Ignite Creation Date:
2025-12-24 @ 1:51 PM
Ignite Modification Date:
2025-12-24 @ 1:51 PM
Study NCT ID:
NCT04426695
Status:
COMPLETED
Last Update Posted:
2023-01-27
First Post:
2020-06-08
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711751', 'term': 'casirivimab and imdevimab drug combination'}, {'id': 'C000711487', 'term': 'casirivimab'}, {'id': 'C000711488', 'term': 'imdevimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643', 'title': 'Clinical Trial Management', 'organization': 'Regeneron Pharmaceuticals, Inc'}, 'certainAgreement': {'otherDetails': "The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug to Day 169', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1 Cohort 1: Placebo IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 1 (Cohort 1).', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 2, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Phase 1 Cohort 1: R10933+R10987 2400mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 milligrams (mg) intravenously on Day 1 in Phase 1 (Cohort 1).', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Phase 1 Cohort 1: R10933+R10987 8000mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1).', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Phase 2 Cohort 1A: Placebo IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1A).', 'otherNumAtRisk': 198, 'deathsNumAtRisk': 198, 'otherNumAffected': 0, 'seriousNumAtRisk': 198, 'deathsNumAffected': 15, 'seriousNumAffected': 43}, {'id': 'EG004', 'title': 'Phase 2 Cohort 1A: R10933+R10987 2400mg IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).', 'otherNumAtRisk': 202, 'deathsNumAtRisk': 202, 'otherNumAffected': 0, 'seriousNumAtRisk': 202, 'deathsNumAffected': 8, 'seriousNumAffected': 29}, {'id': 'EG005', 'title': 'Phase 2 Cohort 1A: R10933+R10987 8000mg IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).', 'otherNumAtRisk': 197, 'deathsNumAtRisk': 197, 'otherNumAffected': 0, 'seriousNumAtRisk': 197, 'deathsNumAffected': 7, 'seriousNumAffected': 32}, {'id': 'EG006', 'title': 'Phase 2 Cohort 1: Placebo IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1).', 'otherNumAtRisk': 204, 'deathsNumAtRisk': 204, 'otherNumAffected': 0, 'seriousNumAtRisk': 204, 'deathsNumAffected': 28, 'seriousNumAffected': 63}, {'id': 'EG007', 'title': 'Phase 2 Cohort 1: R10933+R10987 2400mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1).', 'otherNumAtRisk': 206, 'deathsNumAtRisk': 206, 'otherNumAffected': 0, 'seriousNumAtRisk': 206, 'deathsNumAffected': 25, 'seriousNumAffected': 47}, {'id': 'EG008', 'title': 'Phase 2 Cohort 1: R10933+R10987 8000mg IV', 'description': 'Participants with O2 saturation \\> 93% on 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'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 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'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 1, 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'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 247, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 247, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 247, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 247, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 247, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 247, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 247, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}, {'value': '310', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.03', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-1.28', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '-1.34', 'spread': '0.09', 'groupId': 'OG002'}, {'value': '-1.31', 'spread': '0.06', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0663', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.02', 'pValueComment': 'P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0204', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Square (LS) Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.05', 'pValueComment': 'P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0172', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '-0.05', 'pValueComment': 'P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.', 'groupDescription': 'To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 to Day 7', 'description': 'Time-weighted average daily change from Day 1 to Day 7 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.', 'unitOfMeasure': 'log10 copies/milliliter (mL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'PRIMARY', 'title': 'Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}, {'value': '225', 'groupId': 'OG002'}, {'value': '445', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '18.6'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '11.5'}, {'value': '12.4', 'groupId': 'OG002', 'lowerLimit': '8.4', 'upperLimit': '17.5'}, {'value': '9.9', 'groupId': 'OG003', 'lowerLimit': '7.3', 'upperLimit': '13.0'}]}]}], 'analyses': [{'pValue': '0.0431', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value was based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7975', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value was based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2048', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value was based on Fisher Exact Test.', 'groupDescription': 'To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 6 to Day 29', 'description': 'Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on high viral load mFAS were reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\\>) 10\\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'PRIMARY', 'title': 'Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '21.8'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '9.5'}, {'value': '10.6', 'groupId': 'OG002', 'lowerLimit': '6.5', 'upperLimit': '16.1'}, {'value': '7.9', 'groupId': 'OG003', 'lowerLimit': '5.3', 'upperLimit': '11.3'}]}]}], 'analyses': [{'pValue': '0.0039', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value was based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2415', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value was based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0195', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value was based on Fisher Exact Test.', 'groupDescription': 'To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 6 to Day 29', 'description': 'Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on seronegative mFAS were reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'PRIMARY', 'title': 'Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}, {'value': '383', 'groupId': 'OG002'}, {'value': '770', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '14.2'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '8.2'}, {'value': '10.7', 'groupId': 'OG002', 'lowerLimit': '7.8', 'upperLimit': '14.2'}, {'value': '8.1', 'groupId': 'OG003', 'lowerLimit': '6.2', 'upperLimit': '10.2'}]}]}], 'analyses': [{'pValue': '0.0085', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< = 5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9902', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< = 5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1486', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< = 5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'groupDescription': 'To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 6 to Day 29', 'description': 'Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on overall FAS were reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.'}, {'type': 'PRIMARY', 'title': 'Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '236', 'groupId': 'OG002'}, {'value': '467', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '24.4'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '14.6'}, {'value': '14.4', 'groupId': 'OG002', 'lowerLimit': '10.2', 'upperLimit': '19.5'}, {'value': '12.2', 'groupId': 'OG003', 'lowerLimit': '9.4', 'upperLimit': '15.5'}]}]}], 'analyses': [{'pValue': '0.0092', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< = 5 or n(1-p) \\<= 5 in any treatment group, p-value was based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2210', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< = 5 or n(1-p) \\<= 5 in any treatment group, p-value was based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0249', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< = 5 or n(1-p) \\<= 5 in any treatment group, p-value was based on Fisher Exact Test.', 'groupDescription': 'To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 29', 'description': 'Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on high viral load mFAS were reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \\> 10\\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'PRIMARY', 'title': 'Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}, {'value': '360', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000', 'lowerLimit': '13.6', 'upperLimit': '26.4'}, {'value': '8.1', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '13.3'}, {'value': '12.2', 'groupId': 'OG002', 'lowerLimit': '7.9', 'upperLimit': '17.8'}, {'value': '10.3', 'groupId': 'OG003', 'lowerLimit': '7.3', 'upperLimit': '13.9'}]}]}], 'analyses': [{'pValue': '0.0045', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< = 5 or n(1-p) \\<= 5 in any treatment group, p-value was based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0714', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< = 5 or n(1-p) \\<= 5 in any treatment group, p-value was based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0061', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< = 5 or n(1-p) \\<= 5 in any treatment group, p-value was based on Fisher Exact Test.', 'groupDescription': 'To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 29', 'description': 'Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on seronegative mFAS were reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'PRIMARY', 'title': 'Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}, {'value': '804', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '18.7'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '10.9'}, {'value': '12.6', 'groupId': 'OG002', 'lowerLimit': '9.5', 'upperLimit': '16.2'}, {'value': '10.2', 'groupId': 'OG003', 'lowerLimit': '8.2', 'upperLimit': '12.5'}]}]}], 'analyses': [{'pValue': '0.0023', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< = 5 or n(1-p) \\<= 5 in any treatment group, p-value was based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3544', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< = 5 or n(1-p) \\<= 5 in any treatment group, p-value was based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0212', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< = 5 or n(1-p) \\<= 5 in any treatment group, p-value was based on Fisher Exact Test.', 'groupDescription': 'To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 29', 'description': 'Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on overall mFAS were reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.'}, {'type': 'PRIMARY', 'title': 'Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '225', 'groupId': 'OG002'}, {'value': '449', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1'}, {'id': 'OG001', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1'}, {'id': 'OG002', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1'}, {'id': 'OG003', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 169', 'description': 'Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the observation period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.'}, {'type': 'PRIMARY', 'title': 'Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '225', 'groupId': 'OG002'}, {'value': '449', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1'}, {'id': 'OG001', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1'}, {'id': 'OG002', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1'}, {'id': 'OG003', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 4', 'description': 'Infusion-related reactions are defined as any relevant adverse event that occurs during the infusion or up to day 4. The severity of adverse events (including test findings classified as adverse events) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.'}, {'type': 'PRIMARY', 'title': 'Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '225', 'groupId': 'OG002'}, {'value': '449', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1'}, {'id': 'OG001', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1'}, {'id': 'OG002', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1'}, {'id': 'OG003', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 29', 'description': 'Hypersensitivity reactions are defined as any relevant adverse event that occurs during the infusion or up to study day 29. The severity of adverse events (including test findings classified as adverse events) were graded according to NCI-CTCAE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.'}, {'type': 'PRIMARY', 'title': 'Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1'}, {'id': 'OG001', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1'}, {'id': 'OG002', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1'}, {'id': 'OG003', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '16.9', 'upperLimit': '30.9'}, {'value': '15.1', 'groupId': 'OG001', 'lowerLimit': '10.5', 'upperLimit': '21.4'}, {'value': '20.3', 'groupId': 'OG002', 'lowerLimit': '14.7', 'upperLimit': '27.8'}, {'value': '17.6', 'groupId': 'OG003', 'lowerLimit': '13.8', 'upperLimit': '22.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 29', 'description': 'Cumulative incidence percentage was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'Cumulative Incidence Percentage', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 \\[Cohort 1\\] and Phase 2 \\[Cohort 1\\].'}, {'type': 'PRIMARY', 'title': 'Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1'}, {'id': 'OG001', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1'}, {'id': 'OG002', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1'}, {'id': 'OG003', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000', 'lowerLimit': '15.7', 'upperLimit': '26.9'}, {'value': '18.9', 'groupId': 'OG001', 'lowerLimit': '14.3', 'upperLimit': '24.8'}, {'value': '11.6', 'groupId': 'OG002', 'lowerLimit': '8.0', 'upperLimit': '16.8'}, {'value': '15.3', 'groupId': 'OG003', 'lowerLimit': '12.2', 'upperLimit': '19.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 29', 'description': 'Cumulative incidence percentage was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'Cumulative Incidence Percentage', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\\>) 10\\^6 copies per milliliter (mL). As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 \\[Cohort 1\\] and Phase 2 \\[Cohort 1\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '236', 'groupId': 'OG002'}, {'value': '467', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '16.2'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '10.0'}, {'value': '8.5', 'groupId': 'OG002', 'lowerLimit': '5.3', 'upperLimit': '12.8'}, {'value': '7.3', 'groupId': 'OG003', 'lowerLimit': '5.1', 'upperLimit': '10.0'}]}]}], 'analyses': [{'pValue': '0.0575', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3133', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0849', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who went on mechanical ventilation by Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \\> 10\\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}, {'value': '360', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '15.7'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '10.4'}, {'value': '7.4', 'groupId': 'OG002', 'lowerLimit': '4.1', 'upperLimit': '12.2'}, {'value': '6.7', 'groupId': 'OG003', 'lowerLimit': '4.3', 'upperLimit': '9.8'}]}]}], 'analyses': [{'pValue': '0.2167', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4123', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2206', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who went on mechanical ventilation at Day 29 based on Seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '454', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '18.2'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '11.2'}, {'value': '10.1', 'groupId': 'OG002', 'lowerLimit': '6.5', 'upperLimit': '14.8'}, {'value': '8.6', 'groupId': 'OG003', 'lowerLimit': '6.2', 'upperLimit': '11.6'}]}]}], 'analyses': [{'pValue': '0.0383', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3296', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0766', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 6 to Day 29', 'description': 'Percentage of participants who died from Day 6 through Day 29 based on high viral load mFAS were reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \\> 10\\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '348', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '20.2'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '9.2'}, {'value': '7.2', 'groupId': 'OG002', 'lowerLimit': '3.9', 'upperLimit': '12.0'}, {'value': '6.0', 'groupId': 'OG003', 'lowerLimit': '3.8', 'upperLimit': '9.1'}]}]}], 'analyses': [{'pValue': '0.0070', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0507', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0051', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 6 to Day 29', 'description': 'Percentage of participants who died from Day 6 through Day 29 Based on seronegative mFAS in pooled analysis phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '236', 'groupId': 'OG002'}, {'value': '467', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '19.6'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '11.5'}, {'value': '11.0', 'groupId': 'OG002', 'lowerLimit': '7.3', 'upperLimit': '15.7'}, {'value': '9.2', 'groupId': 'OG003', 'lowerLimit': '6.7', 'upperLimit': '12.2'}]}]}], 'analyses': [{'pValue': '0.0174', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2900', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0454', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 29', 'description': 'Percentage of participants who died from Day 1 through Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \\> 10\\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}, {'value': '360', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '21.5'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '9.7'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '4.5', 'upperLimit': '12.8'}, {'value': '6.7', 'groupId': 'OG003', 'lowerLimit': '4.3', 'upperLimit': '9.8'}]}]}], 'analyses': [{'pValue': '0.0040', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0413', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0032', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 29', 'description': 'Percentage of participants who died from Day 1 through Day 29 based on seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '236', 'groupId': 'OG002'}, {'value': '467', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '80.3', 'groupId': 'OG000', 'lowerLimit': '74.6', 'upperLimit': '85.3'}, {'value': '89.2', 'groupId': 'OG001', 'lowerLimit': '84.4', 'upperLimit': '92.9'}, {'value': '86.9', 'groupId': 'OG002', 'lowerLimit': '81.9', 'upperLimit': '90.9'}, {'value': '88.0', 'groupId': 'OG003', 'lowerLimit': '84.7', 'upperLimit': '90.8'}]}]}], 'analyses': [{'pValue': '0.0105', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0622', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0088', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who were discharged by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \\> 10\\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}, {'value': '360', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000', 'lowerLimit': '74.3', 'upperLimit': '87.0'}, {'value': '90.1', 'groupId': 'OG001', 'lowerLimit': '84.6', 'upperLimit': '94.1'}, {'value': '89.9', 'groupId': 'OG002', 'lowerLimit': '84.7', 'upperLimit': '93.8'}, {'value': '90.0', 'groupId': 'OG003', 'lowerLimit': '86.4', 'upperLimit': '92.9'}]}]}], 'analyses': [{'pValue': '0.0275', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0223', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0072', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who were discharged by Day 29 based on seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '236', 'groupId': 'OG002'}, {'value': '467', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000', 'lowerLimit': '15.9', 'upperLimit': '26.8'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '20.4'}, {'value': '17.4', 'groupId': 'OG002', 'lowerLimit': '12.8', 'upperLimit': '22.8'}, {'value': '16.3', 'groupId': 'OG003', 'lowerLimit': '13.0', 'upperLimit': '19.9'}]}]}], 'analyses': [{'pValue': '0.1032', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3350', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1314', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 29', 'description': 'Percentage of participants who died or were readmitted to hospital over time based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)were reported. Readmission to hospital was based on investigator report.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \\> 10\\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}, {'value': '360', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '31.8'}, {'value': '11.6', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '17.4'}, {'value': '12.8', 'groupId': 'OG002', 'lowerLimit': '8.4', 'upperLimit': '18.4'}, {'value': '12.2', 'groupId': 'OG003', 'lowerLimit': '9.0', 'upperLimit': '16.1'}]}]}], 'analyses': [{'pValue': '0.00024', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0054', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who died or were readmitted to hospital at Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Readmission to hospital was based on investigator report.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '391', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '20.3'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '12.1'}, {'value': '11.7', 'groupId': 'OG002', 'lowerLimit': '8.1', 'upperLimit': '16.7'}, {'value': '9.7', 'groupId': 'OG003', 'lowerLimit': '7.3', 'upperLimit': '12.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'Cumulative Incidence Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \\> 10\\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}, {'value': '308', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '22.7'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '10.5'}, {'value': '8.4', 'groupId': 'OG002', 'lowerLimit': '5.1', 'upperLimit': '13.5'}, {'value': '7.0', 'groupId': 'OG003', 'lowerLimit': '4.8', 'upperLimit': '10.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A)were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'Cumulative Incidence Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}, {'value': '377', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '16.8'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '10.3'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': '13.8'}, {'value': '7.7', 'groupId': 'OG003', 'lowerLimit': '5.5', 'upperLimit': '10.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Number of participants with cumulative incidence of mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'Cumulative Incidence Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \\> 10\\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '295', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '16.8'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '11.0'}, {'value': '7.9', 'groupId': 'OG002', 'lowerLimit': '4.8', 'upperLimit': '13.0'}, {'value': '7.0', 'groupId': 'OG003', 'lowerLimit': '4.8', 'upperLimit': '10.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants with cumulative incidence of mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'Cumulative Incidence Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}, {'value': '377', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000', 'lowerLimit': '14.6', 'upperLimit': '24.9'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '15.0'}, {'value': '15.0', 'groupId': 'OG002', 'lowerLimit': '11.0', 'upperLimit': '20.4'}, {'value': '12.7', 'groupId': 'OG003', 'lowerLimit': '9.9', 'upperLimit': '16.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'Cumulative Incidence Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \\> 10\\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '295', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000', 'lowerLimit': '14.6', 'upperLimit': '27.3'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '13.8'}, {'value': '12.7', 'groupId': 'OG002', 'lowerLimit': '8.7', 'upperLimit': '18.6'}, {'value': '10.7', 'groupId': 'OG003', 'lowerLimit': '7.9', 'upperLimit': '14.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'Cumulative Incidence Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '236', 'groupId': 'OG002'}, {'value': '467', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '6.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '5.0'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': '5.0'}, {'value': '4.0', 'groupId': 'OG003', 'lowerLimit': '4.0', 'upperLimit': '5.0'}]}]}], 'analyses': [{'pValue': '0.0533', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0411', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0229', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 56', 'description': 'Time to discharge from hospital based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \\> 10\\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}, {'value': '360', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG001', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG002', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '6.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '5.0'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': '4.0'}, {'value': '4.0', 'groupId': 'OG003', 'lowerLimit': '3.0', 'upperLimit': '4.0'}]}]}], 'analyses': [{'pValue': '0.0218', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Stratified Log Rank Test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0156', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Stratified Log Rank Test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0067', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Stratified Log Rank Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 56', 'description': 'Time to discharge from hospital based on Seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '730', 'groupId': 'OG000'}, {'value': '740', 'groupId': 'OG001'}, {'value': '733', 'groupId': 'OG002'}, {'value': '1473', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1'}, {'id': 'OG001', 'title': 'Pooled R10933+R10987 2400 mg IV', 'description': 'Participants received a single dose of R10933+R10987 2400 mg intravenously on Day 1'}, {'id': 'OG002', 'title': 'Pooled R10933+R10987 8000 mg IV', 'description': 'Participants received a single dose of R10933+R10987 8000 mg intravenously on Day 1.'}, {'id': 'OG003', 'title': 'Pooled Combined R10933+R10987 IV', 'description': 'Participants received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 169', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '730', 'groupId': 'OG000'}, {'value': '740', 'groupId': 'OG001'}, {'value': '733', 'groupId': 'OG002'}, {'value': '1473', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1'}, {'id': 'OG001', 'title': 'Pooled R10933+R10987 2400 mg IV', 'description': 'Participants received a single dose of R10933+R10987 2400 mg intravenously on Day 1'}, {'id': 'OG002', 'title': 'Pooled R10933+R10987 8000 mg IV', 'description': 'Participants received a single dose of R10933+R10987 8000 mg intravenously on Day 1'}, {'id': 'OG003', 'title': 'Pooled Combined R10933+R10987 IV', 'description': 'Participants received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 4', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.'}, {'type': 'SECONDARY', 'title': 'Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '730', 'groupId': 'OG000'}, {'value': '740', 'groupId': 'OG001'}, {'value': '733', 'groupId': 'OG002'}, {'value': '1473', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1'}, {'id': 'OG001', 'title': 'Pooled R10933+R10987 2400 mg IV', 'description': 'Participants received a single dose of R10933+R10987 2400 mg intravenously on Day 1'}, {'id': 'OG002', 'title': 'Pooled R10933+R10987 8000 mg IV', 'description': 'Participants received a single dose of R10933+R10987 8000 mg intravenously on Day 1'}, {'id': 'OG003', 'title': 'Pooled Combined R10933+R10987 IV', 'description': 'Participants received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 29', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}, {'value': '92', 'groupId': 'OG005'}, {'value': '106', 'groupId': 'OG006'}, {'value': '198', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '28.0'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '17.2'}, {'value': '17.1', 'groupId': 'OG002', 'lowerLimit': '9.7', 'upperLimit': '27.0'}, {'value': '13.0', 'groupId': 'OG003', 'lowerLimit': '8.2', 'upperLimit': '19.1'}, {'value': '4.4', 'groupId': 'OG004', 'lowerLimit': '1.2', 'upperLimit': '11.0'}, {'value': '3.3', 'groupId': 'OG005', 'lowerLimit': '0.7', 'upperLimit': '9.2'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '1.5', 'groupId': 'OG007', 'lowerLimit': '0.3', 'upperLimit': '4.4'}]}]}], 'analyses': [{'pValue': '0.2162', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8783', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5583', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7189', 'groupIds': ['OG004', 'OG005'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0429', 'groupIds': ['OG004', 'OG006'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2103', 'groupIds': ['OG004', 'OG007'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '159', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}, {'value': '88', 'groupId': 'OG005'}, {'value': '101', 'groupId': 'OG006'}, {'value': '189', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '30.9'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '14.2'}, {'value': '10.0', 'groupId': 'OG002', 'lowerLimit': '4.4', 'upperLimit': '13.6'}, {'value': '8.2', 'groupId': 'OG003', 'lowerLimit': '4.4', 'upperLimit': '13.6'}, {'value': '9.3', 'groupId': 'OG004', 'lowerLimit': '4.1', 'upperLimit': '17.5'}, {'value': '3.4', 'groupId': 'OG005', 'lowerLimit': '0.7', 'upperLimit': '9.6'}, {'value': '5.0', 'groupId': 'OG006', 'lowerLimit': '1.6', 'upperLimit': '11.2'}, {'value': '4.2', 'groupId': 'OG007', 'lowerLimit': '1.8', 'upperLimit': '8.2'}]}]}], 'analyses': [{'pValue': '0.0223', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1256', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0230', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1298', 'groupIds': ['OG004', 'OG005'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2642', 'groupIds': ['OG004', 'OG006'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0970', 'groupIds': ['OG004', 'OG007'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 6 to Day 29', 'description': 'Percentage of participants who died from Day 6 through Day 29 in phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}, {'value': '92', 'groupId': 'OG005'}, {'value': '106', 'groupId': 'OG006'}, {'value': '198', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000', 'lowerLimit': '13.7', 'upperLimit': '34.4'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '15.6'}, {'value': '11.0', 'groupId': 'OG002', 'lowerLimit': '5.1', 'upperLimit': '19.8'}, {'value': '9.3', 'groupId': 'OG003', 'lowerLimit': '5.3', 'upperLimit': '14.8'}, {'value': '8.9', 'groupId': 'OG004', 'lowerLimit': '3.9', 'upperLimit': '16.8'}, {'value': '3.3', 'groupId': 'OG005', 'lowerLimit': '0.7', 'upperLimit': '9.2'}, {'value': '5.7', 'groupId': 'OG006', 'lowerLimit': '2.1', 'upperLimit': '11.9'}, {'value': '4.5', 'groupId': 'OG007', 'lowerLimit': '2.1', 'upperLimit': '8.5'}]}]}], 'analyses': [{'pValue': '0.0147', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0669', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0094', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1306', 'groupIds': ['OG004', 'OG005'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3576', 'groupIds': ['OG004', 'OG006'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1476', 'groupIds': ['OG004', 'OG007'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 29', 'description': 'Percentage of participants who died from Day 1 through Day 29 in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}, {'value': '92', 'groupId': 'OG005'}, {'value': '106', 'groupId': 'OG006'}, {'value': '198', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '57.9', 'upperLimit': '80.4'}, {'value': '85.0', 'groupId': 'OG001', 'lowerLimit': '75.3', 'upperLimit': '92.0'}, {'value': '84.1', 'groupId': 'OG002', 'lowerLimit': '74.4', 'upperLimit': '91.3'}, {'value': '84.6', 'groupId': 'OG003', 'lowerLimit': '78.1', 'upperLimit': '89.8'}, {'value': '90.0', 'groupId': 'OG004', 'lowerLimit': '81.9', 'upperLimit': '95.3'}, {'value': '94.6', 'groupId': 'OG005', 'lowerLimit': '87.8', 'upperLimit': '98.2'}, {'value': '94.3', 'groupId': 'OG006', 'lowerLimit': '88.1', 'upperLimit': '97.9'}, {'value': '94.4', 'groupId': 'OG007', 'lowerLimit': '90.3', 'upperLimit': '97.2'}]}]}], 'analyses': [{'pValue': '0.0481', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0535', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0199', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2784', 'groupIds': ['OG004', 'OG005'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2510', 'groupIds': ['OG004', 'OG006'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1702', 'groupIds': ['OG004', 'OG007'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who were discharged in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}, {'value': '92', 'groupId': 'OG005'}, {'value': '106', 'groupId': 'OG006'}, {'value': '198', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '39.1'}, {'value': '13.8', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '23.3'}, {'value': '14.6', 'groupId': 'OG002', 'lowerLimit': '7.8', 'upperLimit': '24.2'}, {'value': '14.2', 'groupId': 'OG003', 'lowerLimit': '9.2', 'upperLimit': '20.5'}, {'value': '22.2', 'groupId': 'OG004', 'lowerLimit': '14.1', 'upperLimit': '32.2'}, {'value': '9.8', 'groupId': 'OG005', 'lowerLimit': '4.6', 'upperLimit': '17.8'}, {'value': '11.3', 'groupId': 'OG006', 'lowerLimit': '6.0', 'upperLimit': '18.9'}, {'value': '10.6', 'groupId': 'OG007', 'lowerLimit': '6.7', 'upperLimit': '15.8'}]}]}], 'analyses': [{'pValue': '0.0500', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0663', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0229', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0208', 'groupIds': ['OG004', 'OG005'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0388', 'groupIds': ['OG004', 'OG006'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0092', 'groupIds': ['OG004', 'OG007'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 29', 'description': 'Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) by Day 29 were reported. Readmission to hospital was based on investigator report.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}, {'value': '90', 'groupId': 'OG006'}, {'value': '168', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A'}, {'id': 'OG007', 'title': 'Phase 2: Cohort 1A Combined R10933+R10987', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg or 8000 mg) intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '35.6'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '16.5'}, {'value': '11.4', 'groupId': 'OG002', 'lowerLimit': '6.1', 'upperLimit': '20.7'}, {'value': '9.6', 'groupId': 'OG003', 'lowerLimit': '5.9', 'upperLimit': '15.4'}, {'value': '9.6', 'groupId': 'OG004', 'lowerLimit': '4.9', 'upperLimit': '18.3'}, {'value': '3.6', 'groupId': 'OG005', 'lowerLimit': '1.2', 'upperLimit': '10.9'}, {'value': '5.9', 'groupId': 'OG006', 'lowerLimit': '2.7', 'upperLimit': '12.8'}, {'value': '4.8', 'groupId': 'OG007', 'lowerLimit': '2.6', 'upperLimit': '9.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 29', 'description': 'Percentage of participants with cumulative incidence of death in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) up to Day 29 from randomization were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'Cumulative Incidence Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '77', 'groupId': 'OG005'}, {'value': '90', 'groupId': 'OG006'}, {'value': '167', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '30.0'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '17.8'}, {'value': '17.6', 'groupId': 'OG002', 'lowerLimit': '10.8', 'upperLimit': '27.9'}, {'value': '13.4', 'groupId': 'OG003', 'lowerLimit': '8.9', 'upperLimit': '19.8'}, {'value': '4.7', 'groupId': 'OG004', 'lowerLimit': '1.8', 'upperLimit': '12.1'}, {'value': '3.5', 'groupId': 'OG005', 'lowerLimit': '1.1', 'upperLimit': '10.5'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '1.7', 'groupId': 'OG007', 'lowerLimit': '0.5', 'upperLimit': '5.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants with cumulative incidence of mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'Cumulative Incidence Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '77', 'groupId': 'OG005'}, {'value': '90', 'groupId': 'OG006'}, {'value': '167', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000', 'lowerLimit': '21.0', 'upperLimit': '42.7'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '22.3'}, {'value': '21.2', 'groupId': 'OG002', 'lowerLimit': '13.8', 'upperLimit': '31.9'}, {'value': '17.0', 'groupId': 'OG003', 'lowerLimit': '12.0', 'upperLimit': '23.8'}, {'value': '11.8', 'groupId': 'OG004', 'lowerLimit': '6.5', 'upperLimit': '20.8'}, {'value': '4.7', 'groupId': 'OG005', 'lowerLimit': '1.8', 'upperLimit': '12.1'}, {'value': '5.9', 'groupId': 'OG006', 'lowerLimit': '2.7', 'upperLimit': '12.8'}, {'value': '5.4', 'groupId': 'OG007', 'lowerLimit': '2.9', 'upperLimit': '9.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants with cumulative incidence of death or mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'Cumulative Incidence Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}, {'value': '86', 'groupId': 'OG005'}, {'value': '99', 'groupId': 'OG006'}, {'value': '198', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '15.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '7.0'}, {'value': '6.0', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '9.0'}, {'value': '6.0', 'groupId': 'OG003', 'lowerLimit': '4.0', 'upperLimit': '7.0'}, {'value': '4.0', 'groupId': 'OG004', 'lowerLimit': '3.0', 'upperLimit': '4.0'}, {'value': '3.0', 'groupId': 'OG005', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '3.0', 'groupId': 'OG006', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '3.0', 'groupId': 'OG007', 'lowerLimit': '2.0', 'upperLimit': '4.0'}]}]}], 'analyses': [{'pValue': '0.0370', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1596', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0444', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1802', 'groupIds': ['OG004', 'OG005'], 'statisticalMethod': 'stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0407', 'groupIds': ['OG004', 'OG006'], 'statisticalMethod': 'stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0523', 'groupIds': ['OG004', 'OG007'], 'statisticalMethod': 'stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 56', 'description': 'Time to discharge from hospital up to Day 56 was reported.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}, {'value': '80', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}, {'value': '88', 'groupId': 'OG006'}, {'value': '167', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.52', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-2.03', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-1.95', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '-2.00', 'spread': '0.10', 'groupId': 'OG003'}, {'value': '-1.28', 'spread': '0.14', 'groupId': 'OG004'}, {'value': '-1.88', 'spread': '0.14', 'groupId': 'OG005'}, {'value': '-2.01', 'spread': '0.14', 'groupId': 'OG006'}, {'value': '-1.95', 'spread': '0.10', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.0245', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0554', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0179', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0035', 'groupIds': ['OG004', 'OG005'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG004', 'OG006'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG004', 'OG007'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 to Day 11', 'description': 'TWA change from baseline in viral load up to Day 11 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 11, was measured by RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}, {'value': '82', 'groupId': 'OG005'}, {'value': '93', 'groupId': 'OG006'}, {'value': '175', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.72', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-3.68', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '-3.69', 'spread': '0.20', 'groupId': 'OG002'}, {'value': '-3.69', 'spread': '0.14', 'groupId': 'OG003'}, {'value': '-2.66', 'spread': '0.21', 'groupId': 'OG004'}, {'value': '-3.31', 'spread': '0.21', 'groupId': 'OG005'}, {'value': '-3.58', 'spread': '0.20', 'groupId': 'OG006'}, {'value': '-3.45', 'spread': '0.14', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.0013', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0010', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0250', 'groupIds': ['OG004', 'OG005'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0012', 'groupIds': ['OG004', 'OG006'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0014', 'groupIds': ['OG004', 'OG007'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 to Day 29', 'description': 'TWA change from baseline in viral load up to Day 29 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 29, was measured by quantitative RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}, {'value': '92', 'groupId': 'OG005'}, {'value': '106', 'groupId': 'OG006'}, {'value': '198', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'title': 'Change at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '76', 'groupId': 'OG006'}, {'value': '144', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-1.10', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '-0.93', 'spread': '0.19', 'groupId': 'OG002'}, {'value': '-0.92', 'spread': '0.14', 'groupId': 'OG003'}, {'value': '-0.85', 'spread': '0.21', 'groupId': 'OG004'}, {'value': '-1.03', 'spread': '0.20', 'groupId': 'OG005'}, {'value': '-1.41', 'spread': '0.19', 'groupId': 'OG006'}, {'value': '-1.23', 'spread': '0.14', 'groupId': 'OG007'}]}]}, {'title': 'Change at Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}, {'value': '97', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-1.97', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-2.28', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '-1.91', 'spread': '0.25', 'groupId': 'OG002'}, {'value': '-2.11', 'spread': '0.17', 'groupId': 'OG003'}, {'value': '-1.55', 'spread': '0.25', 'groupId': 'OG004'}, {'value': '-2.21', 'spread': '0.26', 'groupId': 'OG005'}, {'value': '-2.24', 'spread': '0.24', 'groupId': 'OG006'}, {'value': '-2.21', 'spread': '0.18', 'groupId': 'OG007'}]}]}, {'title': 'Change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '91', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-1.97', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-2.92', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '-3.22', 'spread': '0.25', 'groupId': 'OG002'}, {'value': '-3.09', 'spread': '0.18', 'groupId': 'OG003'}, {'value': '-2.29', 'spread': '0.26', 'groupId': 'OG004'}, {'value': '-3.06', 'spread': '0.25', 'groupId': 'OG005'}, {'value': '-3.49', 'spread': '0.24', 'groupId': 'OG006'}, {'value': '-3.27', 'spread': '0.17', 'groupId': 'OG007'}]}]}, {'title': 'Change at Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '49', 'groupId': 'OG006'}, {'value': '91', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-2.56', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-3.89', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '-4.16', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '-4.03', 'spread': '0.19', 'groupId': 'OG003'}, {'value': '-2.90', 'spread': '0.28', 'groupId': 'OG004'}, {'value': '-3.75', 'spread': '0.26', 'groupId': 'OG005'}, {'value': '-3.85', 'spread': '0.24', 'groupId': 'OG006'}, {'value': '-3.80', 'spread': '0.18', 'groupId': 'OG007'}]}]}, {'title': 'Change at Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '47', 'groupId': 'OG006'}, {'value': '85', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-3.22', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '-4.23', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '-4.57', 'spread': '0.30', 'groupId': 'OG002'}, {'value': '-4.41', 'spread': '0.21', 'groupId': 'OG003'}, {'value': '-3.88', 'spread': '0.32', 'groupId': 'OG004'}, {'value': '-4.76', 'spread': '0.30', 'groupId': 'OG005'}, {'value': '-4.34', 'spread': '0.27', 'groupId': 'OG006'}, {'value': '-4.52', 'spread': '0.2', 'groupId': 'OG007'}]}]}, {'title': 'Change at Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '50', 'groupId': 'OG006'}, {'value': '93', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-3.76', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '-5.18', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '-5.00', 'spread': '0.29', 'groupId': 'OG002'}, {'value': '-5.10', 'spread': '0.21', 'groupId': 'OG003'}, {'value': '-4.22', 'spread': '0.31', 'groupId': 'OG004'}, {'value': '-4.56', 'spread': '0.29', 'groupId': 'OG005'}, {'value': '-5.05', 'spread': '0.27', 'groupId': 'OG006'}, {'value': '-4.82', 'spread': '0.20', 'groupId': 'OG007'}]}]}, {'title': 'Change at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}, {'value': '57', 'groupId': 'OG006'}, {'value': '104', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-4.42', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-5.41', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '-5.25', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '-5.34', 'spread': '0.19', 'groupId': 'OG003'}, {'value': '-4.14', 'spread': '0.28', 'groupId': 'OG004'}, {'value': '-5.03', 'spread': '0.27', 'groupId': 'OG005'}, {'value': '-5.23', 'spread': '0.25', 'groupId': 'OG006'}, {'value': '-5.14', 'spread': '0.18', 'groupId': 'OG007'}]}]}, {'title': 'Change at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}, {'value': '93', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-5.29', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-5.74', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '-5.95', 'spread': '0.24', 'groupId': 'OG002'}, {'value': '-5.85', 'spread': '0.17', 'groupId': 'OG003'}, {'value': '-5.37', 'spread': '0.30', 'groupId': 'OG004'}, {'value': '-5.75', 'spread': '0.29', 'groupId': 'OG005'}, {'value': '-5.77', 'spread': '0.25', 'groupId': 'OG006'}, {'value': '-5.75', 'spread': '0.19', 'groupId': 'OG007'}]}]}, {'title': 'Change at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}, {'value': '62', 'groupId': 'OG006'}, {'value': '109', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-5.90', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-6.46', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-6.60', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '-6.54', 'spread': '0.13', 'groupId': 'OG003'}, {'value': '-5.77', 'spread': '0.27', 'groupId': 'OG004'}, {'value': '-6.34', 'spread': '0.26', 'groupId': 'OG005'}, {'value': '-6.36', 'spread': '0.23', 'groupId': 'OG006'}, {'value': '-6.35', 'spread': '0.17', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.0623', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Difference vs. Placebo by Day 29', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0203', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Difference vs. Placebo by Day 29', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0193', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Difference vs. Placebo by Day 29', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1206', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Difference vs. Placebo by Day 29', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0911', 'groupIds': ['OG004', 'OG006'], 'groupDescription': 'Difference vs. Placebo by Day 29', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0645', 'groupIds': ['OG004', 'OG007'], 'groupDescription': 'Difference vs. Placebo by Day 29', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Days 3, 5, 7, 9, 11, 13, 15, 22 and 29', 'description': 'Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. "Number of Participants Analyzed" = participants with measurements at baseline. "Number Analyzed" = participants with measurements for both baseline and the specific study day. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}, {'value': '92', 'groupId': 'OG005'}, {'value': '106', 'groupId': 'OG006'}, {'value': '198', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'title': 'Percent change at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '76', 'groupId': 'OG006'}, {'value': '144', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-92.04', 'groupId': 'OG000', 'lowerLimit': '-97.12', 'upperLimit': '-78.01'}, {'value': '-87.52', 'groupId': 'OG001', 'lowerLimit': '-94.82', 'upperLimit': '-69.93'}, {'value': '-88.15', 'groupId': 'OG002', 'lowerLimit': '-95.07', 'upperLimit': '-71.52'}, {'value': '-87.94', 'groupId': 'OG003', 'lowerLimit': '-93.51', 'upperLimit': '-77.61'}, {'value': '-85.92', 'groupId': 'OG004', 'lowerLimit': '-94.47', 'upperLimit': '-64.12'}, {'value': '-90.65', 'groupId': 'OG005', 'lowerLimit': '-96.19', 'upperLimit': '-77.01'}, {'value': '-96.15', 'groupId': 'OG006', 'lowerLimit': '-98.37', 'upperLimit': '-90.90'}, {'value': '-94.15', 'groupId': 'OG007', 'lowerLimit': '-96.86', 'upperLimit': '-89.09'}]}]}, {'title': 'Percent change at Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}, {'value': '97', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-98.92', 'groupId': 'OG000', 'lowerLimit': '-99.68', 'upperLimit': '-96.35'}, {'value': '-99.48', 'groupId': 'OG001', 'lowerLimit': '-99.82', 'upperLimit': '-98.50'}, {'value': '-98.76', 'groupId': 'OG002', 'lowerLimit': '-99.59', 'upperLimit': '-96.20'}, {'value': '-99.23', 'groupId': 'OG003', 'lowerLimit': '-99.64', 'upperLimit': '-98.34'}, {'value': '-97.18', 'groupId': 'OG004', 'lowerLimit': '-99.09', 'upperLimit': '-91.23'}, {'value': '-99.38', 'groupId': 'OG005', 'lowerLimit': '-99.81', 'upperLimit': '-97.96'}, {'value': '-99.42', 'groupId': 'OG006', 'lowerLimit': '-99.81', 'upperLimit': '-98.26'}, {'value': '-99.39', 'groupId': 'OG007', 'lowerLimit': '-99.73', 'upperLimit': '-98.63'}]}]}, {'title': 'Percent change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '91', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-98.92', 'groupId': 'OG000', 'lowerLimit': '-99.73', 'upperLimit': '-95.76'}, {'value': '-99.88', 'groupId': 'OG001', 'lowerLimit': '-99.96', 'upperLimit': '-99.62'}, {'value': '-99.94', 'groupId': 'OG002', 'lowerLimit': '-99.98', 'upperLimit': '-99.82'}, {'value': '-99.92', 'groupId': 'OG003', 'lowerLimit': '-99.96', 'upperLimit': '-99.82'}, {'value': '-99.49', 'groupId': 'OG004', 'lowerLimit': '-99.84', 'upperLimit': '-98.36'}, {'value': '-99.91', 'groupId': 'OG005', 'lowerLimit': '-99.97', 'upperLimit': '-99.73'}, {'value': '-99.97', 'groupId': 'OG006', 'lowerLimit': '-99.99', 'upperLimit': '-99.90'}, {'value': '-99.95', 'groupId': 'OG007', 'lowerLimit': '-99.98', 'upperLimit': '-99.88'}]}]}, {'title': 'Percent change at Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '49', 'groupId': 'OG006'}, {'value': '91', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-99.72', 'groupId': 'OG000', 'lowerLimit': '-99.94', 'upperLimit': '-98.80'}, {'value': '-99.99', 'groupId': 'OG001', 'lowerLimit': '-100.00', 'upperLimit': '-99.96'}, {'value': '-99.99', 'groupId': 'OG002', 'lowerLimit': '-100.00', 'upperLimit': '-99.98'}, {'value': '-99.99', 'groupId': 'OG003', 'lowerLimit': '-100.00', 'upperLimit': '-99.98'}, {'value': '-99.87', 'groupId': 'OG004', 'lowerLimit': '-99.96', 'upperLimit': '-99.56'}, {'value': '-99.98', 'groupId': 'OG005', 'lowerLimit': '-99.99', 'upperLimit': '-99.94'}, {'value': '-99.99', 'groupId': 'OG006', 'lowerLimit': '-100.00', 'upperLimit': '-99.96'}, {'value': '-99.98', 'groupId': 'OG007', 'lowerLimit': '-99.99', 'upperLimit': '-99.97'}]}]}, {'title': 'Percent change at Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '47', 'groupId': 'OG006'}, {'value': '85', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-99.94', 'groupId': 'OG000', 'lowerLimit': '-99.99', 'upperLimit': '-99.70'}, {'value': '-99.99', 'groupId': 'OG001', 'lowerLimit': '-100.00', 'upperLimit': '-99.98'}, {'value': '-100.00', 'groupId': 'OG002', 'lowerLimit': '-100.00', 'upperLimit': '-99.99'}, {'value': '-100.00', 'groupId': 'OG003', 'lowerLimit': '-100.00', 'upperLimit': '-99.99'}, {'value': '-99.99', 'groupId': 'OG004', 'lowerLimit': '-100.00', 'upperLimit': '-99.94'}, {'value': '-100.00', 'groupId': 'OG005', 'lowerLimit': '-100.00', 'upperLimit': '-99.99'}, {'value': '-100.00', 'groupId': 'OG006', 'lowerLimit': '-100.00', 'upperLimit': '-99.98'}, {'value': '-100.00', 'groupId': 'OG007', 'lowerLimit': '-100.00', 'upperLimit': '-99.99'}]}]}, {'title': 'Percent change at Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '50', 'groupId': 'OG006'}, {'value': '93', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-99.98', 'groupId': 'OG000', 'lowerLimit': '-100.00', 'upperLimit': '-99.91'}, {'value': '-100.00', 'groupId': 'OG001', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG002', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG003', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-99.99', 'groupId': 'OG004', 'lowerLimit': '-100.00', 'upperLimit': '-99.98'}, {'value': '-100.00', 'groupId': 'OG005', 'lowerLimit': '-100.00', 'upperLimit': '-99.99'}, {'value': '-100.00', 'groupId': 'OG006', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG007', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}]}]}, {'title': 'Percent change at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}, {'value': '57', 'groupId': 'OG006'}, {'value': '104', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-100.00', 'groupId': 'OG000', 'lowerLimit': '-100.00', 'upperLimit': '-99.98'}, {'value': '-100.00', 'groupId': 'OG001', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG002', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG003', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-99.99', 'groupId': 'OG004', 'lowerLimit': '-100.00', 'upperLimit': '-99.97'}, {'value': '-100.00', 'groupId': 'OG005', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG006', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG007', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}]}]}, {'title': 'Percent change at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}, {'value': '93', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-100.00', 'groupId': 'OG000', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG001', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG002', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG003', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG004', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG005', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG006', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG007', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}]}]}, {'title': 'Percent change at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}, {'value': '62', 'groupId': 'OG006'}, {'value': '109', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-100.00', 'groupId': 'OG000', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG001', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG002', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG003', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG004', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG005', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG006', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}, {'value': '-100.00', 'groupId': 'OG007', 'lowerLimit': '-100.00', 'upperLimit': '-100.00'}]}]}], 'analyses': [{'pValue': '0.0623', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Percent Difference vs. Placebo at Day 29', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0203', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Percent Difference vs. Placebo at Day 29', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0193', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Percent Difference vs. Placebo at Day 29', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1206', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Percent Difference vs. Placebo at Day 29', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0911', 'groupIds': ['OG004', 'OG006'], 'groupDescription': 'Percent Difference vs. Placebo at Day 29', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0645', 'groupIds': ['OG004', 'OG007'], 'groupDescription': 'Percent Difference vs. Placebo at Day 29', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Days 3, 5, 7, 9, 11, 13, 15, 22 and 29', 'description': 'Percent change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Number of Participants Analyzed" = participants with measurements at baseline. "Number Analyzed" = participants with measurements for both baseline and the specific study day. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '247', 'groupId': 'OG003'}, {'value': '103', 'groupId': 'OG004'}, {'value': '102', 'groupId': 'OG005'}, {'value': '118', 'groupId': 'OG006'}, {'value': '220', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '25.2'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '14.7'}, {'value': '16.9', 'groupId': 'OG002', 'lowerLimit': '10.7', 'upperLimit': '25.0'}, {'value': '12.6', 'groupId': 'OG003', 'lowerLimit': '8.7', 'upperLimit': '17.3'}, {'value': '3.9', 'groupId': 'OG004', 'lowerLimit': '1.1', 'upperLimit': '9.6'}, {'value': '2.9', 'groupId': 'OG005', 'lowerLimit': '0.6', 'upperLimit': '8.4'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '1.4', 'groupId': 'OG007', 'lowerLimit': '0.3', 'upperLimit': '3.9'}]}]}], 'analyses': [{'pValue': '0.0481', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9880', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2498', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0000', 'groupIds': ['OG004', 'OG005'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0457', 'groupIds': ['OG004', 'OG006'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2153', 'groupIds': ['OG004', 'OG007'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\\>) 10\\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '243', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '98', 'groupId': 'OG005'}, {'value': '113', 'groupId': 'OG006'}, {'value': '211', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '26.0'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '16.7'}, {'value': '15.7', 'groupId': 'OG002', 'lowerLimit': '9.5', 'upperLimit': '23.6'}, {'value': '12.8', 'groupId': 'OG003', 'lowerLimit': '8.8', 'upperLimit': '17.6'}, {'value': '7.0', 'groupId': 'OG004', 'lowerLimit': '2.9', 'upperLimit': '13.9'}, {'value': '3.1', 'groupId': 'OG005', 'lowerLimit': '0.6', 'upperLimit': '8.7'}, {'value': '4.4', 'groupId': 'OG006', 'lowerLimit': '1.5', 'upperLimit': '10.0'}, {'value': '3.8', 'groupId': 'OG007', 'lowerLimit': '1.7', 'upperLimit': '7.3'}]}]}], 'analyses': [{'pValue': '0.0811', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6701', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2006', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3313', 'groupIds': ['OG004', 'OG005'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5542', 'groupIds': ['OG004', 'OG006'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2214', 'groupIds': ['OG004', 'OG007'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 6 to Day 29', 'description': 'Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\\>) 10\\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '247', 'groupId': 'OG003'}, {'value': '103', 'groupId': 'OG004'}, {'value': '102', 'groupId': 'OG005'}, {'value': '118', 'groupId': 'OG006'}, {'value': '220', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '28.8'}, {'value': '10.9', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '17.5'}, {'value': '16.9', 'groupId': 'OG002', 'lowerLimit': '10.7', 'upperLimit': '25.0'}, {'value': '13.8', 'groupId': 'OG003', 'lowerLimit': '9.7', 'upperLimit': '18.7'}, {'value': '6.8', 'groupId': 'OG004', 'lowerLimit': '2.8', 'upperLimit': '13.5'}, {'value': '2.9', 'groupId': 'OG005', 'lowerLimit': '0.6', 'upperLimit': '8.4'}, {'value': '5.1', 'groupId': 'OG006', 'lowerLimit': '1.9', 'upperLimit': '10.7'}, {'value': '4.1', 'groupId': 'OG007', 'lowerLimit': '1.9', 'upperLimit': '7.6'}]}]}], 'analyses': [{'pValue': '0.0389', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5208', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1079', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3315', 'groupIds': ['OG004', 'OG005'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5797', 'groupIds': ['OG004', 'OG006'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3036', 'groupIds': ['OG004', 'OG007'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 29', 'description': 'Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\\>) 10\\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '247', 'groupId': 'OG003'}, {'value': '103', 'groupId': 'OG004'}, {'value': '102', 'groupId': 'OG005'}, {'value': '118', 'groupId': 'OG006'}, {'value': '220', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000', 'lowerLimit': '63.5', 'upperLimit': '79.8'}, {'value': '83.7', 'groupId': 'OG001', 'lowerLimit': '76.2', 'upperLimit': '89.6'}, {'value': '78.8', 'groupId': 'OG002', 'lowerLimit': '70.3', 'upperLimit': '85.8'}, {'value': '81.4', 'groupId': 'OG003', 'lowerLimit': '76.0', 'upperLimit': '86.0'}, {'value': '90.3', 'groupId': 'OG004', 'lowerLimit': '82.9', 'upperLimit': '95.2'}, {'value': '96.1', 'groupId': 'OG005', 'lowerLimit': '90.3', 'upperLimit': '98.9'}, {'value': '94.9', 'groupId': 'OG006', 'lowerLimit': '89.3', 'upperLimit': '98.1'}, {'value': '95.5', 'groupId': 'OG007', 'lowerLimit': '91.8', 'upperLimit': '97.8'}]}]}], 'analyses': [{'pValue': '0.0364', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2795', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0588', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0364', 'groupIds': ['OG004', 'OG005'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2795', 'groupIds': ['OG004', 'OG006'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0588', 'groupIds': ['OG004', 'OG007'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who were discharged in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\\>) 10\\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '247', 'groupId': 'OG003'}, {'value': '103', 'groupId': 'OG004'}, {'value': '102', 'groupId': 'OG005'}, {'value': '118', 'groupId': 'OG006'}, {'value': '220', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000', 'lowerLimit': '17.4', 'upperLimit': '33.1'}, {'value': '18.6', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '26.4'}, {'value': '22.9', 'groupId': 'OG002', 'lowerLimit': '15.7', 'upperLimit': '31.5'}, {'value': '20.6', 'groupId': 'OG003', 'lowerLimit': '15.8', 'upperLimit': '26.2'}, {'value': '16.5', 'groupId': 'OG004', 'lowerLimit': '9.9', 'upperLimit': '25.1'}, {'value': '10.8', 'groupId': 'OG005', 'lowerLimit': '5.5', 'upperLimit': '18.5'}, {'value': '11.9', 'groupId': 'OG006', 'lowerLimit': '6.6', 'upperLimit': '19.1'}, {'value': '11.4', 'groupId': 'OG007', 'lowerLimit': '7.5', 'upperLimit': '16.3'}]}]}], 'analyses': [{'pValue': '0.2635', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8013', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4160', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2194', 'groupIds': ['OG004', 'OG005'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3240', 'groupIds': ['OG004', 'OG006'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1981', 'groupIds': ['OG004', 'OG007'], 'pValueComment': 'P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \\< =5 or n(1-p) \\<= 5 in any treatment group, p-value is based on Fisher Exact Test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 29', 'description': 'Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) over time were reported. Readmission to hospital was based on investigator report.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\\>) 10\\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '200', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}, {'value': '91', 'groupId': 'OG005'}, {'value': '100', 'groupId': 'OG006'}, {'value': '191', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000', 'lowerLimit': '14.9', 'upperLimit': '29.4'}, {'value': '11.2', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '18.2'}, {'value': '17.9', 'groupId': 'OG002', 'lowerLimit': '11.9', 'upperLimit': '26.3'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '10.5', 'upperLimit': '19.5'}, {'value': '7.2', 'groupId': 'OG004', 'lowerLimit': '3.5', 'upperLimit': '14.4'}, {'value': '3.1', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '9.4'}, {'value': '5.3', 'groupId': 'OG006', 'lowerLimit': '2.4', 'upperLimit': '11.5'}, {'value': '4.3', 'groupId': 'OG007', 'lowerLimit': '2.3', 'upperLimit': '8.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 29', 'description': 'Cumulative Incidence of Death Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'Cumulative Incidence Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\\>) 10\\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '187', 'groupId': 'OG003'}, {'value': '83', 'groupId': 'OG004'}, {'value': '90', 'groupId': 'OG005'}, {'value': '100', 'groupId': 'OG006'}, {'value': '190', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000', 'lowerLimit': '12.3', 'upperLimit': '26.2'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '15.3'}, {'value': '18.0', 'groupId': 'OG002', 'lowerLimit': '12.0', 'upperLimit': '26.5'}, {'value': '13.1', 'groupId': 'OG003', 'lowerLimit': '9.4', 'upperLimit': '18.1'}, {'value': '4.0', 'groupId': 'OG004', 'lowerLimit': '1.5', 'upperLimit': '10.4'}, {'value': '3.1', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '9.2'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '1.5', 'groupId': 'OG007', 'lowerLimit': '0.5', 'upperLimit': '4.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 29', 'description': 'Cumulative Incidence of Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'Cumulative Incidence Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\\>) 10\\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '187', 'groupId': 'OG003'}, {'value': '83', 'groupId': 'OG004'}, {'value': '90', 'groupId': 'OG005'}, {'value': '100', 'groupId': 'OG006'}, {'value': '190', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'groupId': 'OG000', 'lowerLimit': '20.2', 'upperLimit': '35.9'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '9.8', 'upperLimit': '22.5'}, {'value': '24.4', 'groupId': 'OG002', 'lowerLimit': '17.6', 'upperLimit': '33.4'}, {'value': '19.5', 'groupId': 'OG003', 'lowerLimit': '15.0', 'upperLimit': '25.1'}, {'value': '9.1', 'groupId': 'OG004', 'lowerLimit': '4.9', 'upperLimit': '16.8'}, {'value': '4.1', 'groupId': 'OG005', 'lowerLimit': '1.6', 'upperLimit': '10.5'}, {'value': '5.3', 'groupId': 'OG006', 'lowerLimit': '2.4', 'upperLimit': '11.5'}, {'value': '4.8', 'groupId': 'OG007', 'lowerLimit': '2.6', 'upperLimit': '8.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 29', 'description': 'Cumulative Incidence of Death or Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'Cumulative Incidence Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\\>) 10\\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '247', 'groupId': 'OG003'}, {'value': '103', 'groupId': 'OG004'}, {'value': '102', 'groupId': 'OG005'}, {'value': '118', 'groupId': 'OG006'}, {'value': '220', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1'}, {'id': 'OG001', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG002', 'title': 'Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG003', 'title': 'Phase 3 (Cohort 1): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.'}, {'id': 'OG004', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 1A): Combined R10933+R10987 IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '10.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '8.0'}, {'value': '7.0', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '8.0'}, {'value': '7.0', 'groupId': 'OG003', 'lowerLimit': '6.0', 'upperLimit': '8.0'}, {'value': '4.0', 'groupId': 'OG004', 'lowerLimit': '3.0', 'upperLimit': '4.0'}, {'value': '3.0', 'groupId': 'OG005', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '3.0', 'groupId': 'OG006', 'lowerLimit': '2.0', 'upperLimit': '3.0'}, {'value': '3.0', 'groupId': 'OG007', 'lowerLimit': '3.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 56', 'description': 'Time to Discharge in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\\>) 10\\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \\[Cohort 1\\] and Phase 2 \\[Cohort 1A\\].'}, {'type': 'SECONDARY', 'title': 'Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '149', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1'}, {'id': 'OG001', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1'}, {'id': 'OG002', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1'}, {'id': 'OG003', 'title': 'Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 Combined IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1'}], 'classes': [{'title': 'Time-weighted average change from baseline from Day 1 to Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '-0.60', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '-0.50', 'spread': '0.08', 'groupId': 'OG003'}]}]}, {'title': 'Time-weighted average change from baseline from Day 1 to Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.92', 'spread': '0.14', 'groupId': 'OG002'}, {'value': '-0.89', 'spread': '0.10', 'groupId': 'OG003'}]}]}, {'title': 'Time-weighted average change from baseline from Day 1 to Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.23', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-1.23', 'spread': '0.14', 'groupId': 'OG002'}, {'value': '-1.23', 'spread': '0.10', 'groupId': 'OG003'}]}]}, {'title': 'Time-weighted average change from baseline from Day 1 to Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.93', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.47', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-1.58', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '-1.52', 'spread': '0.11', 'groupId': 'OG003'}]}]}, {'title': 'Time-weighted average change from baseline from Day 1 to Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.12', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.72', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '-1.78', 'spread': '0.17', 'groupId': 'OG002'}, {'value': '-1.75', 'spread': '0.12', 'groupId': 'OG003'}]}]}, {'title': 'Time-weighted average change from baseline from Day 1 to Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.33', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-1.96', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-1.95', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '-1.96', 'spread': '0.12', 'groupId': 'OG003'}]}]}, {'title': 'Time-weighted average change from baseline from Day 1 to Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.50', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-2.19', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-2.16', 'spread': '0.19', 'groupId': 'OG002'}, {'value': '-2.18', 'spread': '0.13', 'groupId': 'OG003'}]}]}, {'title': 'Time-weighted average change from baseline from Day 1 to Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.89', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-2.62', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '-2.64', 'spread': '0.22', 'groupId': 'OG002'}, {'value': '-2.63', 'spread': '0.15', 'groupId': 'OG003'}]}]}, {'title': 'Time-weighted average change from baseline from Day 1 to Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.35', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-2.98', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '-2.95', 'spread': '0.24', 'groupId': 'OG002'}, {'value': '-2.97', 'spread': '0.17', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to Day 29', 'description': 'Time-weighted average daily change over time up to Day 29 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.', 'unitOfMeasure': 'log10 copies/milliliter (mL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Seronegative modified full analysis set (mFAS) = all participants in mFAS with documented seroneg status at baseline. "Number of Participants Analyzed" = participants with measurements at baseline. "Number Analyzed" = participants with measurements at both baseline and specific study day. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected/reported for Phase 1 \\[Cohort 1\\] and Phase 2 \\[Cohort 1\\].'}, {'type': 'SECONDARY', 'title': 'Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '149', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1'}, {'id': 'OG001', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1'}, {'id': 'OG002', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1'}, {'id': 'OG003', 'title': 'Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 Combined IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1'}], 'classes': [{'title': 'Time-weighted average change from baseline from Day 1 to Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '-1.08', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '-0.94', 'spread': '0.16', 'groupId': 'OG003'}]}]}, {'title': 'Time-weighted average change from baseline from Day 1 to Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.18', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-2.08', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '-2.28', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '-2.18', 'spread': '0.19', 'groupId': 'OG003'}]}]}, {'title': 'Time-weighted average change from baseline from Day 1 to Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.62', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-2.76', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '-2.56', 'spread': '0.29', 'groupId': 'OG002'}, {'value': '-2.67', 'spread': '0.20', 'groupId': 'OG003'}]}]}, {'title': 'Time-weighted average change from baseline from Day 1 to Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.68', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '-3.24', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '-3.16', 'spread': '0.32', 'groupId': 'OG002'}, {'value': '-3.20', 'spread': '0.22', 'groupId': 'OG003'}]}]}, {'title': 'Time-weighted average change from baseline from Day 1 to Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.55', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-3.74', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '-3.94', 'spread': '0.37', 'groupId': 'OG002'}, {'value': '-3.87', 'spread': '0.26', 'groupId': 'OG003'}]}]}, {'title': 'Time-weighted average change from baseline from Day 1 to Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.04', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-5.01', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '-4.25', 'spread': '0.39', 'groupId': 'OG002'}, {'value': '-4.68', 'spread': '0.26', 'groupId': 'OG003'}]}]}, {'title': 'Time-weighted average change from baseline from Day 1 to Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.60', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-4.67', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '-5.01', 'spread': '0.36', 'groupId': 'OG002'}, {'value': '-4.84', 'spread': '0.25', 'groupId': 'OG003'}]}]}, {'title': 'Time-weighted average change from baseline from Day 1 to Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.89', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-5.21', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '-5.25', 'spread': '0.32', 'groupId': 'OG002'}, {'value': '-5.23', 'spread': '0.22', 'groupId': 'OG003'}]}]}, {'title': 'Time-weighted average change from baseline from Day 1 to Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.01', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-6.04', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '-6.16', 'spread': '0.28', 'groupId': 'OG002'}, {'value': '-6.10', 'spread': '0.20', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Days 3, 5, 7, 9, 11, 13, 15, 22 and 29', 'description': 'Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.', 'unitOfMeasure': 'log10 copies/milliliter (mL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Seronegative modified full analysis set (mFAS) = all participants in mFAS with documented seroneg status at baseline. "Number of Participants Analyzed" = participants with measurements at baseline. "Number Analyzed" = participants with measurements at both baseline and specific study day. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected/reported for Phase 1 \\[Cohort 1\\] and Phase 2 \\[Cohort 1\\].'}, {'type': 'SECONDARY', 'title': 'Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1'}, {'id': 'OG001', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1'}, {'id': 'OG002', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1'}, {'id': 'OG003', 'title': 'Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of 2400mg or 8000 mg R10933+R10987 intravenously on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '34.8'}, {'value': '17.7', 'groupId': 'OG001', 'lowerLimit': '11.5', 'upperLimit': '24.0'}, {'value': '22.0', 'groupId': 'OG002', 'lowerLimit': '15.1', 'upperLimit': '28.9'}, {'value': '19.8', 'groupId': 'OG003', 'lowerLimit': '15.2', 'upperLimit': '24.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through Day 29', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 \\[Cohort 1\\] and Phase 2 \\[Cohort 1\\].'}, {'type': 'SECONDARY', 'title': 'Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1'}, {'id': 'OG001', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1'}, {'id': 'OG002', 'title': 'Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1'}, {'id': 'OG003', 'title': 'Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of 2400mg or 8000 mg R10933+R10987 intravenously on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '29.2'}, {'value': '23.4', 'groupId': 'OG001', 'lowerLimit': '17.2', 'upperLimit': '29.6'}, {'value': '13.8', 'groupId': 'OG002', 'lowerLimit': '8.8', 'upperLimit': '18.7'}, {'value': '18.5', 'groupId': 'OG003', 'lowerLimit': '14.5', 'upperLimit': '22.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through Day 29', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\\>) 10\\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 \\[Cohort 1\\] and Phase 2 \\[Cohort 1\\].'}, {'type': 'SECONDARY', 'title': 'Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 [Cohort 1]: R10983+10987 2400mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1'}, {'id': 'OG001', 'title': 'Phase 1 [Cohort 1]: R10983+10987 8000mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1'}], 'classes': [{'title': 'AUC0-28 of Casirivimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3026', 'spread': '719', 'groupId': 'OG000'}, {'value': '9678', 'spread': '3362', 'groupId': 'OG001'}]}]}, {'title': 'AUC0-28 of Imdevimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2582', 'spread': '581', 'groupId': 'OG000'}, {'value': '8680', 'spread': '2930', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 28', 'unitOfMeasure': 'day*mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Phase 1 (Cohort 1) who received any study drug of casirivimab and imdevimab and who had at least 1 non-missing drug concentration measurement following the first dose of study drug'}, {'type': 'SECONDARY', 'title': 'Concentration at the End of Infusion (Ceoi)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '155', 'groupId': 'OG003'}, {'value': '181', 'groupId': 'OG004'}, {'value': '178', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '214', 'groupId': 'OG010'}, {'value': '207', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 [Cohort 1]: R10983+10987 2400mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 1 (Cohort 1).'}, {'id': 'OG001', 'title': 'Phase 1 [Cohort 1]: R10983+10987 8000mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1).'}, {'id': 'OG002', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 2400mg IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 8000mg IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG004', 'title': 'Phase 2 (Cohort 1): R10933+R10987 2400mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1).'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1): R10933+R10987 8000mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1).'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 2): R10933+R10987 2400mg IV', 'description': 'Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 2): R10933+R10987 8000mg IV', 'description': 'Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).'}, {'id': 'OG008', 'title': 'Phase 2 (Cohort 3): R10933+R10987 2400mg IV', 'description': 'Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).'}, {'id': 'OG009', 'title': 'Phase 2 (Cohort 3): R10933+R10987 8000mg IV', 'description': 'Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).'}, {'id': 'OG010', 'title': 'Phase 3 (Cohort 1): R10933+R10987 2400mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 3 (Cohort 1).'}, {'id': 'OG011', 'title': 'Phase 3 (Cohort 1): R10933+R10987 8000mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 3 (Cohort 1).'}], 'classes': [{'title': 'Ceoi of Casirivimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '155', 'groupId': 'OG003'}, {'value': '181', 'groupId': 'OG004'}, {'value': '178', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '214', 'groupId': 'OG010'}, {'value': '207', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '231', 'spread': '110', 'groupId': 'OG000'}, {'value': '776', 'spread': '372', 'groupId': 'OG001'}, {'value': '272', 'spread': '124', 'groupId': 'OG002'}, {'value': '847', 'spread': '300', 'groupId': 'OG003'}, {'value': '288', 'spread': '86.8', 'groupId': 'OG004'}, {'value': '848', 'spread': '261', 'groupId': 'OG005'}, {'value': '286', 'spread': '93.5', 'groupId': 'OG006'}, {'value': '921', 'spread': '262', 'groupId': 'OG007'}, {'value': '284', 'spread': '69.3', 'groupId': 'OG008'}, {'value': '708', 'spread': '128', 'groupId': 'OG009'}, {'value': '307', 'spread': '153', 'groupId': 'OG010'}, {'value': '908', 'spread': '338', 'groupId': 'OG011'}]}]}, {'title': 'Ceoi of Imdevimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '155', 'groupId': 'OG003'}, {'value': '181', 'groupId': 'OG004'}, {'value': '178', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '214', 'groupId': 'OG010'}, {'value': '207', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '243', 'spread': '117', 'groupId': 'OG000'}, {'value': '795', 'spread': '371', 'groupId': 'OG001'}, {'value': '283', 'spread': '127', 'groupId': 'OG002'}, {'value': '868', 'spread': '298', 'groupId': 'OG003'}, {'value': '300', 'spread': '87.3', 'groupId': 'OG004'}, {'value': '880', 'spread': '268', 'groupId': 'OG005'}, {'value': '302', 'spread': '94.0', 'groupId': 'OG006'}, {'value': '946', 'spread': '244', 'groupId': 'OG007'}, {'value': '290', 'spread': '81.7', 'groupId': 'OG008'}, {'value': '738', 'spread': '124', 'groupId': 'OG009'}, {'value': '312', 'spread': '157', 'groupId': 'OG010'}, {'value': '945', 'spread': '351', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'unitOfMeasure': 'milligrams per liter (mg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received any study drug of casirivimab and imdevimab'}, {'type': 'SECONDARY', 'title': 'Concentration at Day 28 (C28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}, {'value': '91', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}, {'value': '26', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '149', 'groupId': 'OG010'}, {'value': '146', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 [Cohort 1]: R10983+10987 2400mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 1 (Cohort 1).'}, {'id': 'OG001', 'title': 'Phase 1 [Cohort 1]: R10983+10987 8000mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1)'}, {'id': 'OG002', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 2400mg IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG003', 'title': 'Phase 2 (Cohort 1A): R10933+R10987 8000mg IV', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'OG004', 'title': 'Phase 2 (Cohort 1): R10933+R10987 2400mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1).'}, {'id': 'OG005', 'title': 'Phase 2 (Cohort 1): R10933+R10987 8000mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1).'}, {'id': 'OG006', 'title': 'Phase 2 (Cohort 2): R10933+R10987 2400mg IV', 'description': 'Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).'}, {'id': 'OG007', 'title': 'Phase 2 (Cohort 2): R10933+R10987 8000mg IV', 'description': 'Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).'}, {'id': 'OG008', 'title': 'Phase 2 (Cohort 3): R10933+R10987 2400mg IV', 'description': 'Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).'}, {'id': 'OG009', 'title': 'Phase 2 (Cohort 3): R10933+R10987 8000mg IV', 'description': 'Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).'}, {'id': 'OG010', 'title': 'Phase 3 (Cohort 1): R10933+R10987 2400mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 3 (Cohort 1).'}, {'id': 'OG011', 'title': 'Phase 3 (Cohort 1): R10933+R10987 8000mg IV', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 3 (Cohort 1).'}], 'classes': [{'title': 'C28 of Casirivimab', 'categories': [{'measurements': [{'value': '50.7', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '166', 'spread': '108', 'groupId': 'OG001'}, {'value': '64.8', 'spread': '35.9', 'groupId': 'OG002'}, {'value': '174', 'spread': '65.1', 'groupId': 'OG003'}, {'value': '50.0', 'spread': '20.4', 'groupId': 'OG004'}, {'value': '144', 'spread': '89.8', 'groupId': 'OG005'}, {'value': '26.4', 'spread': '18.5', 'groupId': 'OG006'}, {'value': '79.4', 'spread': '61.4', 'groupId': 'OG007'}, {'value': '9.06', 'spread': '2.64', 'groupId': 'OG008'}, {'value': '67.8', 'spread': '31.1', 'groupId': 'OG009'}, {'value': '49.1', 'spread': '40.4', 'groupId': 'OG010'}, {'value': '140', 'spread': '66.1', 'groupId': 'OG011'}]}]}, {'title': 'C28 of Imdevimab', 'categories': [{'measurements': [{'value': '36.1', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '131', 'spread': '84.1', 'groupId': 'OG001'}, {'value': '54.7', 'spread': '37.6', 'groupId': 'OG002'}, {'value': '150', 'spread': '62.9', 'groupId': 'OG003'}, {'value': '39.8', 'spread': '18.9', 'groupId': 'OG004'}, {'value': '113', 'spread': '68.8', 'groupId': 'OG005'}, {'value': '18.7', 'spread': '14.7', 'groupId': 'OG006'}, {'value': '60.0', 'spread': '53.9', 'groupId': 'OG007'}, {'value': '5.25', 'spread': '4.12', 'groupId': 'OG008'}, {'value': '52.4', 'spread': '24.7', 'groupId': 'OG009'}, {'value': '40.8', 'spread': '48.3', 'groupId': 'OG010'}, {'value': '114', 'spread': '62.6', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received any study drug of casirivimab and imdevimab and who had at least 1 non-missing drug concentration measurement following the first dose of study drug'}, {'type': 'SECONDARY', 'title': 'Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}, {'value': '497', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1'}, {'id': 'OG001', 'title': 'Pooled R10933+R10987 2400mg IV', 'description': 'Participants received a single 2400mg intravenous dose of R10933+R10987'}, {'id': 'OG002', 'title': 'Pooled REGN10933+REGN10987 8000mg IV', 'description': 'Participants received a single 8000 mg intravenous dose of R10933+R10987'}], 'classes': [{'categories': [{'measurements': [{'value': '489', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}, {'value': '484', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 169', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ADA analysis set includes all treated participants from all phases/cohorts who received any amount of study drug and had at least one non-missing antibody variables result following the first dose of study drug or placebo.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}, {'value': '497', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received a single intravenous dose of placebo matching R10933+R10987'}, {'id': 'OG001', 'title': 'Pooled R10933+R10987 2400mg IV', 'description': 'Participants received a single 2400mg dose of R10933+R10987 intravenously on Day 1'}, {'id': 'OG002', 'title': 'Pooled REGN10933+REGN10987 8000mg IV', 'description': 'Participants received a single 8000 mg dose of R10933+R10987 intravenously on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '467', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}, {'value': '463', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 169', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ADA analysis set includes all treated participants from all phases/cohorts who received any amount of study drug and had at least one non-missing antibody variables result following the first dose of study drug or placebo.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}, {'value': '497', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 2/3) Placebo', 'description': 'Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1'}, {'id': 'OG001', 'title': 'Pooled (Phase 2/3) R10933+R10987 2400mg IV', 'description': 'Participants received a single 2400mg intravenous dose of R10933+R10987'}, {'id': 'OG002', 'title': 'Pooled (Phase 2/3) REGN10933+REGN10987 8000mg IV', 'description': 'Participants received a single 8000 mg intravenous dose of R10933+R10987'}], 'classes': [{'title': 'Anti-drug Antibody (ADA) Negative', 'categories': [{'measurements': [{'value': '489', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}, {'value': '484', 'groupId': 'OG002'}]}]}, {'title': 'Neutralizing antibody (NAb) Positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 57', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'NAb analysis set includes all Phase 2/3 treated participants who received any study drug, had at least one non-missing antibody result following the first dose of study drug, and either tested negative at all ADA sampling times or tested positive for ADA with at least one non-missing NAb result after first dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}, {'value': '497', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled (Phase 2/3) Placebo', 'description': 'Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1'}, {'id': 'OG001', 'title': 'Pooled (Phase 2/3) R10933+R10987 2400mg IV', 'description': 'Participants received a single 2400mg intravenous dose of R10933+R10987'}, {'id': 'OG002', 'title': 'Pooled (Phase 2/3) REGN10933+REGN10987 8000mg IV', 'description': 'Participants received a single 8000 mg intravenous dose of R10933+R10987'}], 'classes': [{'title': 'Anti-drug Antibody (ADA) Negative', 'categories': [{'measurements': [{'value': '467', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}, {'value': '463', 'groupId': 'OG002'}]}]}, {'title': 'Neutralizing antibody (NAb) Positive', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 57', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'NAb analysis set includes all Phase 2/3 treated participants who received any study drug, had at least one non-missing antibody result following the first dose of study drug, and either tested negative at all ADA sampling times or tested positive for ADA with at least one non-missing NAb result after first dose of the study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 1 (Cohort 1).'}, {'id': 'FG001', 'title': 'Phase 1: Cohort 1 (R10933+R10987 2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 milligrams (mg) intravenously on Day 1 in Phase 1 (Cohort 1).'}, {'id': 'FG002', 'title': 'Phase 1: Cohort 1 (R10933+R10987 8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1).'}, {'id': 'FG003', 'title': 'Phase 2: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1)'}, {'id': 'FG004', 'title': 'Phase 2: Cohort 1 (R10933+R10987 2400 mg', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 milligrams (mg) intravenously on Day 1 in Phase 2 (Cohort 1)'}, {'id': 'FG005', 'title': 'Phase 2: Cohort 1 (R10933+R10987 8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1)'}, {'id': 'FG006', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1)'}, {'id': 'FG007', 'title': 'Phase 3: Cohort 1 (R10933+R10987 2400 mg)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 milligrams (mg) intravenously on Day 1 in Phase 3 (Cohort 1)'}, {'id': 'FG008', 'title': 'Phase 3: Cohort 1 (R10933+R10987 8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 3 (Cohort 1)'}, {'id': 'FG009', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'FG010', 'title': 'Phase 2: Cohort 1A (R10933+R10987 2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'FG011', 'title': 'Phase 2: Cohort 1A (R10933+R10987 8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'FG012', 'title': 'Phase 2: Cohort 2 (Placebo)', 'description': 'Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 2).'}, {'id': 'FG013', 'title': 'Phase 2: Cohort 2 (R10933+R10987 2400 mg IV)', 'description': 'Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).'}, {'id': 'FG014', 'title': 'Phase 2: Cohort 2 (R10933+R10987 8000 mg IV)', 'description': 'Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).'}, {'id': 'FG015', 'title': 'Phase 2: Cohort 3 (Placebo)', 'description': 'Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).'}, {'id': 'FG016', 'title': 'Phase 2: Cohort 3 (R10933+R10987 2400 mg IV)', 'description': 'Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).'}, {'id': 'FG017', 'title': 'Phase 2: Cohort 3 (R10933+R10987 8000 mg IV)', 'description': 'Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '208'}, {'groupId': 'FG004', 'numSubjects': '211'}, {'groupId': 'FG005', 'numSubjects': '210'}, {'groupId': 'FG006', 'numSubjects': '251'}, {'groupId': 'FG007', 'numSubjects': '252'}, {'groupId': 'FG008', 'numSubjects': '252'}, {'groupId': 'FG009', 'numSubjects': '201'}, {'groupId': 'FG010', 'numSubjects': '205'}, {'groupId': 'FG011', 'numSubjects': '203'}, {'groupId': 'FG012', 'numSubjects': '52'}, {'groupId': 'FG013', 'numSubjects': '58'}, {'groupId': 'FG014', 'numSubjects': '54'}, {'groupId': 'FG015', 'numSubjects': '12'}, {'groupId': 'FG016', 'numSubjects': '12'}, {'groupId': 'FG017', 'numSubjects': '11'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '204'}, {'groupId': 'FG004', 'numSubjects': '206'}, {'groupId': 'FG005', 'numSubjects': '205'}, {'groupId': 'FG006', 'numSubjects': '247'}, {'groupId': 'FG007', 'numSubjects': '246'}, {'groupId': 'FG008', 'numSubjects': '246'}, {'groupId': 'FG009', 'numSubjects': '198'}, {'groupId': 'FG010', 'numSubjects': '202'}, {'groupId': 'FG011', 'numSubjects': '197'}, {'groupId': 'FG012', 'numSubjects': '51'}, {'groupId': 'FG013', 'numSubjects': '56'}, {'groupId': 'FG014', 'numSubjects': '54'}, {'groupId': 'FG015', 'numSubjects': '12'}, {'groupId': 'FG016', 'numSubjects': '12'}, {'groupId': 'FG017', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '146'}, {'groupId': 'FG004', 'numSubjects': '153'}, {'groupId': 'FG005', 'numSubjects': '148'}, {'groupId': 'FG006', 'numSubjects': '186'}, {'groupId': 'FG007', 'numSubjects': '195'}, {'groupId': 'FG008', 'numSubjects': '189'}, {'groupId': 'FG009', 'numSubjects': '157'}, {'groupId': 'FG010', 'numSubjects': '165'}, {'groupId': 'FG011', 'numSubjects': '166'}, {'groupId': 'FG012', 'numSubjects': '33'}, {'groupId': 'FG013', 'numSubjects': '28'}, {'groupId': 'FG014', 'numSubjects': '31'}, {'groupId': 'FG015', 'numSubjects': '5'}, {'groupId': 'FG016', 'numSubjects': '4'}, {'groupId': 'FG017', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '62'}, {'groupId': 'FG004', 'numSubjects': '58'}, {'groupId': 'FG005', 'numSubjects': '62'}, {'groupId': 'FG006', 'numSubjects': '65'}, {'groupId': 'FG007', 'numSubjects': '57'}, {'groupId': 'FG008', 'numSubjects': '63'}, {'groupId': 'FG009', 'numSubjects': '44'}, {'groupId': 'FG010', 'numSubjects': '40'}, {'groupId': 'FG011', 'numSubjects': '37'}, {'groupId': 'FG012', 'numSubjects': '19'}, {'groupId': 'FG013', 'numSubjects': '30'}, {'groupId': 'FG014', 'numSubjects': '23'}, {'groupId': 'FG015', 'numSubjects': '7'}, {'groupId': 'FG016', 'numSubjects': '8'}, {'groupId': 'FG017', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '25'}, {'groupId': 'FG005', 'numSubjects': '21'}, {'groupId': 'FG006', 'numSubjects': '42'}, {'groupId': 'FG007', 'numSubjects': '23'}, {'groupId': 'FG008', 'numSubjects': '37'}, {'groupId': 'FG009', 'numSubjects': '14'}, {'groupId': 'FG010', 'numSubjects': '8'}, {'groupId': 'FG011', 'numSubjects': '7'}, {'groupId': 'FG012', 'numSubjects': '13'}, {'groupId': 'FG013', 'numSubjects': '25'}, {'groupId': 'FG014', 'numSubjects': '19'}, {'groupId': 'FG015', 'numSubjects': '7'}, {'groupId': 'FG016', 'numSubjects': '8'}, {'groupId': 'FG017', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '14'}, {'groupId': 'FG008', 'numSubjects': '10'}, {'groupId': 'FG009', 'numSubjects': '11'}, {'groupId': 'FG010', 'numSubjects': '12'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Participant Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '22'}, {'groupId': 'FG006', 'numSubjects': '13'}, {'groupId': 'FG007', 'numSubjects': '13'}, {'groupId': 'FG008', 'numSubjects': '10'}, {'groupId': 'FG009', 'numSubjects': '15'}, {'groupId': 'FG010', 'numSubjects': '16'}, {'groupId': 'FG011', 'numSubjects': '17'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Sponsor Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Randomized but Never Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 2324 participants were screened and 2203 participants randomized and treated, 49 participants were randomized but not treated, and 72 discontinued at the screening phase. Reasons for discontinuation at screening phase: 54 - Screen Failure, 10 - Subject Decision, 1- Sponsor Request, 7- Other.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '204', 'groupId': 'BG003'}, {'value': '206', 'groupId': 'BG004'}, {'value': '205', 'groupId': 'BG005'}, {'value': '247', 'groupId': 'BG006'}, {'value': '246', 'groupId': 'BG007'}, {'value': '246', 'groupId': 'BG008'}, {'value': '198', 'groupId': 'BG009'}, {'value': '202', 'groupId': 'BG010'}, {'value': '197', 'groupId': 'BG011'}, {'value': '51', 'groupId': 'BG012'}, {'value': '56', 'groupId': 'BG013'}, {'value': '54', 'groupId': 'BG014'}, {'value': '12', 'groupId': 'BG015'}, {'value': '12', 'groupId': 'BG016'}, {'value': '11', 'groupId': 'BG017'}, {'value': '2203', 'groupId': 'BG018'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 1 (Cohort 1)'}, {'id': 'BG001', 'title': 'Phase 1: Cohort 1 (R10933+R10987 2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 1 (Cohort 1)'}, {'id': 'BG002', 'title': 'Phase 1: Cohort 1 (R10933+R10987 8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1)'}, {'id': 'BG003', 'title': 'Phase 2: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1)'}, {'id': 'BG004', 'title': 'Phase 2: Cohort 1 (R10933+R10987 2400 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1)'}, {'id': 'BG005', 'title': 'Phase 2: Cohort 1 (R10933+R10987 8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1)'}, {'id': 'BG006', 'title': 'Phase 3: Cohort 1 (Placebo)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1).'}, {'id': 'BG007', 'title': 'Phase 3: Cohort 1 (R10933+R10987 2400 mg IV)', 'description': 'Phase 1: Cohort 1 (R10933+R10987 2400 mg IV)Edit Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1.'}, {'id': 'BG008', 'title': 'Phase 3: Cohort 1 (R10933+R10987 8000 mg IV)', 'description': 'Participants with O2 saturation \\> 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 3 (Cohort 1)'}, {'id': 'BG009', 'title': 'Phase 2: Cohort 1A (Placebo)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'BG010', 'title': 'Phase 2: Cohort 1A (R10933+R10987 2400 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'BG011', 'title': 'Phase 2: Cohort 1A (R10933+R10987 8000 mg IV)', 'description': 'Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).'}, {'id': 'BG012', 'title': 'Phase 2: Cohort 2 (Placebo)', 'description': 'Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 2).'}, {'id': 'BG013', 'title': 'Phase 2: Cohort 2 (R10933+R10987 2400 mg IV)', 'description': 'Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).'}, {'id': 'BG014', 'title': 'Phase 2: Cohort 2 (R10933+R10987 8000 mg IV)', 'description': 'Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).'}, {'id': 'BG015', 'title': 'Phase 2: Cohort 3 (Placebo)', 'description': 'Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).'}, {'id': 'BG016', 'title': 'Phase 2: Cohort 3 (R10933+R10987 2400 mg IV)', 'description': 'Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).'}, {'id': 'BG017', 'title': 'Phase 2: Cohort 3 (R10933+R10987 8000 mg IV)', 'description': 'Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).'}, {'id': 'BG018', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age: 18- <40 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}, {'value': '14', 'groupId': 'BG008'}, {'value': '22', 'groupId': 'BG009'}, {'value': '20', 'groupId': 'BG010'}, {'value': '20', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}, {'value': '4', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '1', 'groupId': 'BG016'}, {'value': '1', 'groupId': 'BG017'}, {'value': '212', 'groupId': 'BG018'}]}]}, {'title': 'Age: 40- <65 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, 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'17', 'groupId': 'BG012'}, {'value': '20', 'groupId': 'BG013'}, {'value': '20', 'groupId': 'BG014'}, {'value': '8', 'groupId': 'BG015'}, {'value': '4', 'groupId': 'BG016'}, {'value': '2', 'groupId': 'BG017'}, {'value': '990', 'groupId': 'BG018'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}, {'value': '108', 'groupId': 'BG004'}, {'value': '107', 'groupId': 'BG005'}, {'value': '134', 'groupId': 'BG006'}, {'value': '134', 'groupId': 'BG007'}, {'value': '131', 'groupId': 'BG008'}, {'value': '107', 'groupId': 'BG009'}, {'value': '115', 'groupId': 'BG010'}, {'value': '108', 'groupId': 'BG011'}, {'value': '34', 'groupId': 'BG012'}, {'value': '36', 'groupId': 'BG013'}, {'value': '34', 'groupId': 'BG014'}, {'value': '4', 'groupId': 'BG015'}, {'value': '8', 'groupId': 'BG016'}, {'value': '9', 'groupId': 'BG017'}, {'value': '1213', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '52', 'groupId': 'BG005'}, {'value': '92', 'groupId': 'BG006'}, {'value': '94', 'groupId': 'BG007'}, {'value': '82', 'groupId': 'BG008'}, {'value': '38', 'groupId': 'BG009'}, {'value': '53', 'groupId': 'BG010'}, {'value': '40', 'groupId': 'BG011'}, {'value': '13', 'groupId': 'BG012'}, {'value': '22', 'groupId': 'BG013'}, {'value': '18', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '5', 'groupId': 'BG016'}, {'value': '4', 'groupId': 'BG017'}, {'value': '647', 'groupId': 'BG018'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}, {'value': '148', 'groupId': 'BG004'}, {'value': '146', 'groupId': 'BG005'}, {'value': '146', 'groupId': 'BG006'}, {'value': '140', 'groupId': 'BG007'}, {'value': '155', 'groupId': 'BG008'}, {'value': '148', 'groupId': 'BG009'}, {'value': '138', 'groupId': 'BG010'}, {'value': '143', 'groupId': 'BG011'}, {'value': '35', 'groupId': 'BG012'}, {'value': '33', 'groupId': 'BG013'}, {'value': '30', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '7', 'groupId': 'BG016'}, {'value': '7', 'groupId': 'BG017'}, {'value': '1453', 'groupId': 'BG018'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '11', 'groupId': 'BG010'}, {'value': '14', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '103', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '36', 'groupId': 'BG018'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '11', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '1', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '78', 'groupId': 'BG018'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '10', 'groupId': 'BG018'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}, {'value': '32', 'groupId': 'BG007'}, {'value': '25', 'groupId': 'BG008'}, {'value': '27', 'groupId': 'BG009'}, {'value': '32', 'groupId': 'BG010'}, {'value': '25', 'groupId': 'BG011'}, {'value': '7', 'groupId': 'BG012'}, {'value': '6', 'groupId': 'BG013'}, {'value': '9', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '1', 'groupId': 'BG016'}, {'value': '3', 'groupId': 'BG017'}, {'value': '295', 'groupId': 'BG018'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}, {'value': '146', 'groupId': 'BG004'}, {'value': '134', 'groupId': 'BG005'}, {'value': '159', 'groupId': 'BG006'}, {'value': '151', 'groupId': 'BG007'}, {'value': '158', 'groupId': 'BG008'}, {'value': '111', 'groupId': 'BG009'}, {'value': '116', 'groupId': 'BG010'}, {'value': '131', 'groupId': 'BG011'}, {'value': '33', 'groupId': 'BG012'}, {'value': '39', 'groupId': 'BG013'}, {'value': '36', 'groupId': 'BG014'}, {'value': '8', 'groupId': 'BG015'}, {'value': '9', 'groupId': 'BG016'}, {'value': '5', 'groupId': 'BG017'}, {'value': '1406', 'groupId': 'BG018'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}, {'value': '47', 'groupId': 'BG006'}, {'value': '43', 'groupId': 'BG007'}, {'value': '40', 'groupId': 'BG008'}, {'value': '49', 'groupId': 'BG009'}, {'value': '46', 'groupId': 'BG010'}, {'value': '34', 'groupId': 'BG011'}, {'value': '7', 'groupId': 'BG012'}, {'value': '8', 'groupId': 'BG013'}, {'value': '8', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '1', 'groupId': 'BG016'}, {'value': '3', 'groupId': 'BG017'}, {'value': '378', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set (FAS) included all randomized participants who received at least one dose (full or partial) of the study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-27', 'size': 1458162, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-05-05T13:06', 'hasProtocol': True}, {'date': '2021-07-07', 'size': 844869, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-27T10:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase 1/Phase 2/Phase 3'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-25', 'studyFirstSubmitDate': '2020-06-08', 'resultsFirstSubmitDate': '2022-05-05', 'studyFirstSubmitQcDate': '2020-06-10', 'lastUpdatePostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-28', 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS', 'timeFrame': 'Day 1 to Day 7', 'description': 'Time-weighted average daily change from Day 1 to Day 7 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.'}, {'measure': 'Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS', 'timeFrame': 'Day 6 to Day 29', 'description': 'Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on high viral load mFAS were reported.'}, {'measure': 'Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS', 'timeFrame': 'Day 6 to Day 29', 'description': 'Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on seronegative mFAS were reported.'}, {'measure': 'Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS', 'timeFrame': 'Day 6 to Day 29', 'description': 'Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on overall FAS were reported.'}, {'measure': 'Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS', 'timeFrame': 'Day 1 to Day 29', 'description': 'Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on high viral load mFAS were reported.'}, {'measure': 'Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS', 'timeFrame': 'Day 1 to Day 29', 'description': 'Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on seronegative mFAS were reported.'}, {'measure': 'Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS', 'timeFrame': 'Day 1 to Day 29', 'description': 'Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on overall mFAS were reported.'}, {'measure': 'Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events', 'timeFrame': 'Up to Day 169', 'description': 'Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the observation period.'}, {'measure': 'Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4', 'timeFrame': 'Up to Day 4', 'description': 'Infusion-related reactions are defined as any relevant adverse event that occurs during the infusion or up to day 4. The severity of adverse events (including test findings classified as adverse events) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).'}, {'measure': 'Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29', 'timeFrame': 'Up to Day 29', 'description': 'Hypersensitivity reactions are defined as any relevant adverse event that occurs during the infusion or up to study day 29. The severity of adverse events (including test findings classified as adverse events) were graded according to NCI-CTCAE.'}, {'measure': 'Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS', 'timeFrame': 'Up to Day 29', 'description': 'Cumulative incidence percentage was estimated using Kaplan-Meier method.'}, {'measure': 'Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS', 'timeFrame': 'Up to Day 29', 'description': 'Cumulative incidence percentage was estimated using Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who went on mechanical ventilation by Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who went on mechanical ventilation at Day 29 based on Seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS', 'timeFrame': 'Day 6 to Day 29', 'description': 'Percentage of participants who died from Day 6 through Day 29 based on high viral load mFAS were reported.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS', 'timeFrame': 'Day 6 to Day 29', 'description': 'Percentage of participants who died from Day 6 through Day 29 Based on seronegative mFAS in pooled analysis phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS', 'timeFrame': 'Day 1 to Day 29', 'description': 'Percentage of participants who died from Day 1 through Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS', 'timeFrame': 'Day 1 to Day 29', 'description': 'Percentage of participants who died from Day 1 through Day 29 based on seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who were discharged by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who were discharged by Day 29 based on seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS', 'timeFrame': 'Up to Day 29', 'description': 'Percentage of participants who died or were readmitted to hospital over time based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)were reported. Readmission to hospital was based on investigator report.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who died or were readmitted to hospital at Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Readmission to hospital was based on investigator report.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS', 'timeFrame': 'by Day 29', 'description': 'Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS', 'timeFrame': 'by Day 29', 'description': 'Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A)were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS', 'timeFrame': 'by Day 29', 'description': 'Number of participants with cumulative incidence of mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants with cumulative incidence of mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS', 'timeFrame': 'Up to Day 56', 'description': 'Time to discharge from hospital based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.'}, {'measure': 'Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS', 'timeFrame': 'Up to Day 56', 'description': 'Time to discharge from hospital based on Seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.'}, {'measure': 'Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events', 'timeFrame': 'Up to Day 169'}, {'measure': 'Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4', 'timeFrame': 'Up to Day 4'}, {'measure': 'Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29', 'timeFrame': 'Up to Day 29'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS', 'timeFrame': 'Day 6 to Day 29', 'description': 'Percentage of participants who died from Day 6 through Day 29 in phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS', 'timeFrame': 'Day 1 to Day 29', 'description': 'Percentage of participants who died from Day 1 through Day 29 in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who were discharged in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS', 'timeFrame': 'Up to Day 29', 'description': 'Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) by Day 29 were reported. Readmission to hospital was based on investigator report.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS', 'timeFrame': 'Up to Day 29', 'description': 'Percentage of participants with cumulative incidence of death in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) up to Day 29 from randomization were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants with cumulative incidence of mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants with cumulative incidence of death or mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS', 'timeFrame': 'Up to Day 56', 'description': 'Time to discharge from hospital up to Day 56 was reported.'}, {'measure': 'Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS', 'timeFrame': 'Day 1 to Day 11', 'description': 'TWA change from baseline in viral load up to Day 11 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 11, was measured by RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.'}, {'measure': 'Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29', 'timeFrame': 'Day 1 to Day 29', 'description': 'TWA change from baseline in viral load up to Day 29 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 29, was measured by quantitative RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.'}, {'measure': 'Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time', 'timeFrame': 'Days 3, 5, 7, 9, 11, 13, 15, 22 and 29', 'description': 'Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.'}, {'measure': 'Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time', 'timeFrame': 'Days 3, 5, 7, 9, 11, 13, 15, 22 and 29', 'description': 'Percent change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS', 'timeFrame': 'Day 6 to Day 29', 'description': 'Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS', 'timeFrame': 'Day 1 to Day 29', 'description': 'Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS', 'timeFrame': 'by Day 29', 'description': 'Percentage of participants who were discharged in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS', 'timeFrame': 'Up to Day 29', 'description': 'Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) over time were reported. Readmission to hospital was based on investigator report.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS', 'timeFrame': 'Up to Day 29', 'description': 'Cumulative Incidence of Death Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS', 'timeFrame': 'Up to Day 29', 'description': 'Cumulative Incidence of Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS', 'timeFrame': 'Up to Day 29', 'description': 'Cumulative Incidence of Death or Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.'}, {'measure': 'Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS', 'timeFrame': 'Up to Day 56', 'description': 'Time to Discharge in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.'}, {'measure': 'Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS', 'timeFrame': 'Up to Day 29', 'description': 'Time-weighted average daily change over time up to Day 29 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.'}, {'measure': 'Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS', 'timeFrame': 'Days 3, 5, 7, 9, 11, 13, 15, 22 and 29', 'description': 'Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.'}, {'measure': 'Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS', 'timeFrame': 'Through Day 29'}, {'measure': 'Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS', 'timeFrame': 'Through Day 29'}, {'measure': 'Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28)', 'timeFrame': 'Up to Day 28'}, {'measure': 'Concentration at the End of Infusion (Ceoi)', 'timeFrame': 'Day 1'}, {'measure': 'Concentration at Day 28 (C28)', 'timeFrame': 'Day 28'}, {'measure': 'Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933', 'timeFrame': 'Through Day 169'}, {'measure': 'Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987', 'timeFrame': 'Through Day 169'}, {'measure': 'Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933', 'timeFrame': 'Through Day 57'}, {'measure': 'Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987', 'timeFrame': 'Through Day 57'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronavirus disease 2019 (COVID-19)', 'Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)', 'coronavirus', 'acute respiratory distress syndrome'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '37229174', 'type': 'DERIVED', 'citation': "Somersan-Karakaya S, Mylonakis E, Mou J, Oviedo-Orta E, O'Brien MP, Mas Casullo V, Mahmood A, Hooper AT, Hussein M, Ali S, Marty FM, Forleo-Neto E, Bhore R, Hamilton JD, Herman GA, Hirshberg B, Weinreich DM. Effectiveness of Casirivimab and Imdevimab Antibody Combination in Immunocompromised Hospitalized Patients With Coronavirus Disease 2019: A Post Hoc Analysis in a Phase 1/2/3 Double-Blind Trial. Open Forum Infect Dis. 2023 Apr 19;10(5):ofad211. doi: 10.1093/ofid/ofad211. eCollection 2023 May."}, {'pmid': '36255239', 'type': 'DERIVED', 'citation': 'Hooper AT, Somersan-Karakaya S, McCarthy SE, Mylonakis E, Ali S, Mei J, Bhore R, Mahmood A, Geba GP, Dakin P, Weinreich DM, Yancopoulos GD, Herman GA, Hamilton JD; COVID-19 Phase 2/3 Hospitalized Trial Team. Casirivimab and Imdevimab Treatment Reduces Viral Load and Improves Clinical Outcomes in Seropositive Hospitalized COVID-19 Patients with Nonneutralizing or Borderline Neutralizing Antibodies. mBio. 2022 Dec 20;13(6):e0169922. doi: 10.1128/mbio.01699-22. Epub 2022 Oct 18.'}, {'pmid': '35895508', 'type': 'DERIVED', 'citation': 'Somersan-Karakaya S, Mylonakis E, Menon VP, Wells JC, Ali S, Sivapalasingam S, Sun Y, Bhore R, Mei J, Miller J, Cupelli L, Forleo-Neto E, Hooper AT, Hamilton JD, Pan C, Pham V, Zhao Y, Hosain R, Mahmood A, Davis JD, Turner KC, Kim Y, Cook A, Kowal B, Soo Y, DiCioccio AT, Geba GP, Stahl N, Lipsich L, Braunstein N, Herman GA, Yancopoulos GD, Weinreich DM; COVID-19 Phase 2/3 Hospitalized Trial Team. Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19. J Infect Dis. 2022 Dec 28;227(1):23-34. doi: 10.1093/infdis/jiac320.'}, {'pmid': '35713300', 'type': 'DERIVED', 'citation': 'Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.'}, {'pmid': '34473343', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives are:\n\nPooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)\n\n* To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2\n* To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation\n\nPhase 1/2 (Cohort 1)\n\n* To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation\n* To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal \\[OP\\], or saliva) ≤72 hours prior to randomization and no alternative explanation for current clinical condition. A historical record of positive result from test conducted ≤72 hours prior to randomization is acceptable.\n* Has symptoms consistent with COVID-19, as determined by investigator, with onset ≤10 days before randomization\n* Hospitalized for ≤72 hours with at least 1 of the following at randomization; patients meeting more than one criterion will be categorized in the most severely affected category:\n\n 1. Cohort 1A: With COVID-19 symptoms but not requiring supplemental oxygen\n 2. Cohort 1: Maintains O2 saturation \\>93% on low-flow oxygen as defined in the protocol\n 3. Cohort 2: High-intensity oxygen therapy without mechanical ventilation as defined in the protocol\n 4. Cohort 3: On mechanical ventilation\n\nKey Exclusion Criteria:\n\n* Phase 1 Only: Patients maintaining O2 saturation \\>94% on room air\n* In the opinion of the investigator, unlikely to survive for \\>48 hours from screening\n* Receiving extracorporeal membrane oxygenation (ECMO)\n* Has new-onset stroke or seizure disorder during hospitalization\n* Initiated on renal replacement therapy due to COVID-19\n\nNOTE: Other protocol defined inclusion / exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04426695', 'briefTitle': 'Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients With COVID-19', 'orgStudyIdInfo': {'id': 'R10933-10987-COV-2066'}, 'secondaryIdInfos': [{'id': '2020-002537-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'On Low-Flow Oxygen', 'description': 'Cohort 1 (C1): O2 saturation \\>93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device', 'interventionNames': ['Drug: REGN10933+REGN10987 combination therapy', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'With COVID-19 symptoms but not requiring supplemental O2', 'description': 'Cohort 1A (C1A): With COVID-19 symptoms but not requiring supplemental oxygen', 'interventionNames': ['Drug: REGN10933+REGN10987 combination therapy', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'High O2 No Mechanical Ventilation', 'description': 'Cohort 2 (C2): On high-intensity oxygen (O2) therapy but not on mechanical ventilation', 'interventionNames': ['Drug: REGN10933+REGN10987 combination therapy', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'On Mechanical Ventilation', 'description': 'Cohort 3 (C3): On mechanical ventilation', 'interventionNames': ['Drug: REGN10933+REGN10987 combination therapy', 'Drug: Placebo']}], 'interventions': [{'name': 'REGN10933+REGN10987 combination therapy', 'type': 'DRUG', 'otherNames': ['REGN-COV2', 'REGEN-COV™', 'Ronapreve™', 'casirivimab', 'imdevimab'], 'description': 'Administered intravenously (IV) single dose', 'armGroupLabels': ['High O2 No Mechanical Ventilation', 'On Low-Flow Oxygen', 'On Mechanical Ventilation', 'With COVID-19 symptoms but not requiring supplemental O2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo IV Single Dose', 'armGroupLabels': ['High O2 No Mechanical Ventilation', 'On Low-Flow Oxygen', 'On Mechanical Ventilation', 'With COVID-19 symptoms but not requiring supplemental O2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Regeneron Study Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Regeneron Study Site', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Regeneron Study Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Regeneron Study Site 1', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Regeneron Study Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'Regeneron Study Site', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Regeneron Study Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Regeneron Study Site', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Regeneron Study Site', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Regeneron Study Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Regeneron Study Site', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '34982', 'city': 'Ft. 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