Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-03-12 @ 2:09 PM
Study NCT ID:
NCT04380961
Status:
COMPLETED
Last Update Posted:
2022-06-21
First Post:
2020-05-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease (COVID)-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Brazil', 'Mexico', 'Russia', 'South Africa', 'Spain'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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': 'D018352', 'term': 'Coronavirus Infections'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568922', 'term': 'sirukumab'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Director 1 Study Responsible Physician', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. Expedited reviews will be arranged for abstracts, poster presentations, or other materials. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16', 'description': 'The All Subjects Treated analysis set consisted of all participants who received the study drug. The number of participants at risk in placebo arm in follow-up phase were 59 participants, however, the data for 2 participants in placebo arms were not collected due to pandemic situation, and were excluded from the analysis. Therefore, here number of participants at risk are 57 participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Sirukumab + Standard of Care (SOC): Treatment Phase', 'description': 'Hospitalized participants with confirmed coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with SOC treatment per the discretion of the Investigator.', 'otherNumAtRisk': 139, 'deathsNumAtRisk': 139, 'otherNumAffected': 24, 'seriousNumAtRisk': 139, 'deathsNumAffected': 18, 'seriousNumAffected': 35}, {'id': 'EG001', 'title': 'Sirukumab + SOC: Follow-up Phase', 'description': 'Hospitalized participants with confirmed COVID-19 received IV single dose infusion of sirukumab 5 mg/kg on Day 1 along with SOC treatment per the discretion of the Investigator.', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 1, 'seriousNumAtRisk': 118, 'deathsNumAffected': 4, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Placebo + SOC: Treatment Phase', 'description': 'Hospitalized participants with confirmed COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 16, 'seriousNumAtRisk': 70, 'deathsNumAffected': 13, 'seriousNumAffected': 22}, {'id': 'EG003', 'title': 'Placebo + SOC: Follow-up Phase', 'description': 'Hospitalized participants with confirmed COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 1, 'seriousNumAtRisk': 57, 'deathsNumAffected': 3, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Transaminases Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Troponin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Blood Loss Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Disseminated Intravascular Coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Acute Left Ventricular Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Cardio-Respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Cardiogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Myocardial Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Lower Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Mallory-Weiss Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Mouth Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Retroperitoneal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Multiple Organ Dysfunction Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Bacterial Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Covid-19 Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Enterobacter Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Enterococcal Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Hiv Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Klebsiella Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Staphylococcal Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Streptococcal Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Viral Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Glomerular Filtration Rate Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Hepatic Enzyme Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Transaminases Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Urine Analysis Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Embolic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Haemorrhage Intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Renal Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Acute Respiratory Distress Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Pneumomediastinum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Pneumothorax Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Subcutaneous Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Haemodialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Sustained Improvement of at Least 2 Categories on 6-point Ordinal Clinical Recovery Scale (CRS): Primary Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.00', 'comment': 'NA stands for data Not available as indicates upper limit of 95% CI was not estimable due to less number of events.', 'groupId': 'OG000', 'lowerLimit': '13.00', 'upperLimit': 'NA'}, {'value': '23.00', 'comment': 'NA stands for data Not available as indicates upper limit of 95% CI was not estimable due to less number of events.', 'groupId': 'OG001', 'lowerLimit': '13.00', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 28', 'description': "Time to sustained improvement is defined as an improvement of at least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale sustained until Day 28. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary Analysis Set consisted of all participants in the Intent-to-Treat (ITT) analysis set (which consisted of all participants who were randomized and treated in the study) with confirmed critical COVID-19 disease defined as score of 4 or 5 on the ordinal CRS at baseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an Improvement of At Least 2 Categories Compared to Baseline on 6-point Ordinal CRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'groupId': 'OG000'}, {'value': '55.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': "Percentage of participants with an improvement of at least 2 Categories compared to baseline on 6-point ordinal CRS were reported. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Primary Analysis Set consisted of all participants in the ITT analysis set with confirmed critical COVID-19 disease defined as score of 4 or 5 on the ordinal CRS at baseline. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With All-cause Mortality Up to 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days', 'description': 'Percentage of participants with all-cause mortality up to 28 days were reported. All-cause mortality included all deaths of participants due to any cause.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Primary Analysis Set consisted of all participants in the ITT analysis set with confirmed critical COVID-19 disease defined as score of 4 or 5 on the ordinal CRS at baseline. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Time to Sustained Improvement of at Least 2 Categories on 6-point Ordinal CRS: Intent-to-Treat (ITT) Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.00', 'groupId': 'OG000', 'lowerLimit': '7.00', 'upperLimit': '10.00'}, {'value': '10.00', 'groupId': 'OG001', 'lowerLimit': '8.00', 'upperLimit': '17.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 28', 'description': "Time to sustained improvement is defined as an improvement of at least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale, sustained until Day 28. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set consisted of all participants who were randomized and treated in the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an Improvement of at Least 2 Categories Compared to Baseline on 6-point Ordinal CRS: ITT Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.9', 'groupId': 'OG000'}, {'value': '70.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': "Percentage of participants with an improvement of at least 2 categories compared to baseline on 6-point ordinal CRS were reported. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set consisted of all participants who were randomized and treated in the study. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure. There were 3 participants in the 'Sirukumab + SOC arm' who discontinued the trial before Day 28 and thus were not evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With All-cause Mortality: ITT Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'Percentage of participants with all-cause mortality were reported. All-cause mortality included all deaths of participants due to any cause.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set consisted of all participants who were randomized and treated in the study. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure. There were 3 participants in the 'Sirukumab + SOC arm' who discontinued the trial before Day 28 and thus were not evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serious Adverse Events (SAEs) (Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'groupId': 'OG000'}, {'value': '31.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 28', 'description': 'Percentage of participants with SAEs were reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects treated analysis set consisted of all participants who received the study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Related Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 28', 'description': 'Percentage of participants with related AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects Treated analysis set consisted of all participants who received the study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Severe or Life-threatening, Bacterial, Invasive Fungal, Viral or Opportunistic Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '11.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 28', 'description': 'Percentage of participants with severe or Life-threatening, bacterial, invasive fungal, viral or opportunistic infections were reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects treated analysis set consisted of all participants who received the study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Grade 3 and 4 Neutropenia and Lymphocytopenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'title': 'Neutropenia: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neutropenia: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytopenia: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '7.2', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytopenia: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '10.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 28', 'description': 'Percentage of participants with Grade 3 and 4 neutropenia and lymphocytopenia were reported. The laboratory abnormalities were determined as per division of microbiology and infectious diseases (DMID) adult toxicity as Grade 1: mild (transient or mild discomfort \\[less than {\\<} 48 hours\\]; no medical intervention/therapy required); Grade 2: moderate (mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required); Grade 3: severe (severe marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible); Grade 4: life-threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The All Subjects Treated analysis set consists of all participants who received the study drug. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Increased Alanine Transaminase (ALT) Greater Than or Equal to (>=)3*Upper Limit Normal (ULN) Combined With Increased Bilirubin Greater Than (>)2*ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 28', 'description': 'Percentage of participants with increased ALT \\>=3\\*ULN combined with increased bilirubin \\>2\\*ULN were reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects Treated analysis set consists of all participants who received the study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Improvement of at Least 1 Category on 6-point Ordinal CRS: Primary Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.00', 'groupId': 'OG000', 'lowerLimit': '7.00', 'upperLimit': '21.00'}, {'value': '15.50', 'comment': 'NA stands for data Not available, indicates upper limit of 90% CI was not estimable due to less number of events.', 'groupId': 'OG001', 'lowerLimit': '8.00', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 28', 'description': "Time to sustained improvement is defined as an improvement of at least 1 category relative to baseline on the 6-point ordinal clinical recovery scale, sustained until Day 28. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.", 'unitOfMeasure': 'Days', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary Analysis Set consisted of all participants in the ITT analysis set with confirmed critical COVID-19 disease defined as score of 4 or 5 on the ordinal CRS at baseline.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Improvement of at Least 1 Category on 6-point Ordinal CRS: ITT Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.00', 'groupId': 'OG000', 'lowerLimit': '6.00', 'upperLimit': '8.00'}, {'value': '7.00', 'groupId': 'OG001', 'lowerLimit': '6.00', 'upperLimit': '9.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 28', 'description': "Time to sustained improvement is defined as an improvement of at least 1 category relative to baseline on the 6-point ordinal clinical recovery scale, sustained until Day 28. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.", 'unitOfMeasure': 'Days', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set consisted of all participants who were randomized and treated in the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an Improvement of at Least 1 Category Compared to Baseline on 6-point Ordinal CRS: Primary Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000'}, {'value': '57.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': "The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6), reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: (category 1) not hospitalized, including participants on low level of oxygen; Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Primary Analysis Set consisted of all participants in the ITT analysis set with confirmed critical COVID-19 disease defined as score of 4 or 5 on the ordinal CRS at baseline. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure. There were 3 participants in the 'Sirukumab + SOC arm' who discontinued the trial before Day 28 and thus were not evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an Improvement of at Least 1 Category on 6-point Ordinal CRS: ITT Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.1', 'groupId': 'OG000'}, {'value': '74.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': "The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set consisted of all participants who were randomized and treated in the study. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure. There were 3 participants in the 'Sirukumab + SOC arm' who discontinued the trial before Day 28 and thus were not evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Time From Study Intervention Administration to End of Oxygen Supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'comment': 'NA indicates data not available as upper limit of 90% CI was not estimable due to less number of events.', 'groupId': 'OG000', 'lowerLimit': '10.00', 'upperLimit': 'NA'}, {'value': '20.00', 'comment': 'NA indicates data not available as upper limit of 90% CI was not estimable due to less number of events.', 'groupId': 'OG001', 'lowerLimit': '9.00', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 28', 'description': 'Time from study intervention administration to end of oxygen supplementation was reported.', 'unitOfMeasure': 'Days', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set consisted of all participants who were randomized and treated in the study.'}, {'type': 'SECONDARY', 'title': 'Time From Study Intervention Administration to Hospital Discharge Among the Surviving Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.00', 'groupId': 'OG000', 'lowerLimit': '7.00', 'upperLimit': '9.00'}, {'value': '9.00', 'groupId': 'OG001', 'lowerLimit': '7.00', 'upperLimit': '10.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 28', 'description': 'Time from study intervention administration to hospital discharge among the surviving participants was reported.', 'unitOfMeasure': 'Days', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population restricted to participants surviving up to Day 28.'}, {'type': 'SECONDARY', 'title': 'Total Length of Hospitalization Among the Surviving Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.42', 'spread': '8.274', 'groupId': 'OG000'}, {'value': '11.19', 'spread': '8.370', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 28', 'description': 'Total length of hospitalization, defined as total duration of hospital stay, among the surviving participants was reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population restricted to participants surviving up to Day 28.'}, {'type': 'SECONDARY', 'title': 'Number of Ventilation Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.82', 'spread': '11.062', 'groupId': 'OG000'}, {'value': '6.63', 'spread': '9.546', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 28', 'description': 'Number of ventilation free days in participants on invasive mechanical ventilation (IVM)/extracorporeal membrane oxygenation (ECMO) at baseline was reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The Primary Analysis Set restricted to participants who were on IVM/ECMO at baseline. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'title': 'Day 7: Category 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Category 1.2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Category 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Category 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Category 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.8', 'groupId': 'OG000'}, {'value': '32.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Category 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.4', 'groupId': 'OG000'}, {'value': '35.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Category 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: Category 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '17.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: Category 1.2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '15.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: Category 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: Category 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '15.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: Category 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: Category 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '27.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: Category 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 21: Category 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21: Category 1.2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}, {'value': '22.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 21: Category 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '7.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 21: Category 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21: Category 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21: Category 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21: Category 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Category 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Category 1.2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Category 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Category 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Category 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Category 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Category 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'On Day 7, 14, 21, 28', 'description': "Percentage of participants with clinical status as assessed by 6-point Ordinal CRS were reported. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: Not hospitalized, not requiring supplemental oxygen (category 1.1); Not hospitalized, requiring supplemental oxygen (category 1.2); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Primary Analysis Set consisted of all participants in the ITT set with confirmed critical COVID-19 disease defined as score of 4 or 5 on ordinal CRS at baseline. Here 'N' (number of participants analyzed) included all participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories at specified timepoints."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'title': 'Day 7: Category 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Category 1.2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Category 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Category 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Category 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Category 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Category 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: Category 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.1', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: Category 1.2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: Category 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: Category 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: Category 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: Category 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '15.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: Category 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 21: Category 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.6', 'groupId': 'OG000'}, {'value': '44.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 21: Category 1.2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 21: Category 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 21: Category 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 21: Category 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 21: Category 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}, {'value': '11.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 21: Category 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '12.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Category 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000'}, {'value': '47.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Category 1.2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000'}, {'value': '22.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Category 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Category 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Category 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Category 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 28: Category 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'On Days 7, 14, 21, 28', 'description': "Percentage of participants with clinical status as assessed by 6-point Ordinal CRS (ITT Set) were reported. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: Not hospitalized, not requiring supplemental oxygen (category 1.1); Not hospitalized, requiring supplemental oxygen (category 1.2); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set consisted of all participants who were randomized and treated in the study. Here 'N' (number of participants analyzed) included all participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories at specified timepoints."}, {'type': 'SECONDARY', 'title': 'Total Time on Invasive Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.18', 'spread': '11.062', 'groupId': 'OG000'}, {'value': '21.37', 'spread': '9.546', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 28', 'description': 'Total time on invasive mechanical ventilation in participants who were on invasive mechanical ventilation at baseline was reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The Primary Analysis Set restricted to participants who were on invasive mechanical ventilation at baseline. Here 'N' (number of participants analyzed) included all participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Worse Category Relative to Baseline on the 6-point Ordinal CRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '31.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 5 up to Day 28', 'description': "Percentage of participants with a worse category relative to baseline on the 6-point ordinal CRS for at least one of the daily assessment during the reporting period Day 5 and Day 28 were reported. he 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set consisted of all participants who were randomized and treated in the study. Here 'N' (number of participants analyzed) included all participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 16', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 17', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 18', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 19', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 20', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 22', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 23', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 25', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 26', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 27', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 up to Day 28', 'description': 'Percentage of participants with ECMO over time were reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population restricted to participants who were on ECMO at baseline.'}, {'type': 'SECONDARY', 'title': 'Total Time on ECMO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 28', 'description': 'Total time for participants on ECMO was reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set restricted to participants who were on ECMO at baseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Alive Participants at Day 28, Week 8, and Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.8', 'groupId': 'OG000'}, {'value': '81.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000'}, {'value': '72.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'On Day 28, Week 8 and Week 16', 'description': 'Percentage of alive participants at Day 28, Week 8, and Week 16 were reported. For this outcome measure, at Week 8, data was not collected for participants due to pandemic situation.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set consisted of all participants who were randomized and treated in the study. Here 'N' (number of participants analyzed) included all participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed for specified timepoints."}, {'type': 'SECONDARY', 'title': 'Percentage of Alive Participants That Required Readmission at Week 8, and Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8 and Week 16', 'description': 'Percentage of alive participants that required readmission at Week 8, and Week 16 were reported. For this outcome measure, at Week 8 and Week 16, data was not collected for participants due to pandemic situation.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set consisted of all participants who were randomized and treated in the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SAEs (Follow-up Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 4 up to Week 16', 'description': 'Percentage of participants with SAEs were reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The All Subjects Treated analysis set consists of all participants who received the study drug. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'FG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'Participants Who Entered the Follow-up Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomized but Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Out of 212 participants who started the study and got randomized, 209 participants (139 in Sirukumab + Standard of Care \\[SOC\\] and 70 in Placebo + SOC arm) were treated. Out of 212, 139 participants (96 in Sirukumab + SOC and 43 in Placebo + SOC arms) completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sirukumab + SOC', 'description': 'Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \\[mg/kg\\]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.'}, {'id': 'BG001', 'title': 'Placebo + SOC', 'description': 'Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'spread': '12.91', 'groupId': 'BG000'}, {'value': '57.8', 'spread': '12.91', 'groupId': 'BG001'}, {'value': '57.8', 'spread': '12.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent-to-Treat (ITT) analysis set consisted of all participants who were randomized and treated in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-17', 'size': 2470566, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-04-08T05:13', 'hasProtocol': True}, {'date': '2021-06-28', 'size': 1857382, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-04-08T05:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-23', 'studyFirstSubmitDate': '2020-05-07', 'resultsFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2020-05-07', 'lastUpdatePostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-23', 'studyFirstPostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Sustained Improvement of at Least 2 Categories on 6-point Ordinal Clinical Recovery Scale (CRS): Primary Analysis Set', 'timeFrame': 'Up to Day 28', 'description': "Time to sustained improvement is defined as an improvement of at least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale sustained until Day 28. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With an Improvement of At Least 2 Categories Compared to Baseline on 6-point Ordinal CRS', 'timeFrame': 'Day 28', 'description': "Percentage of participants with an improvement of at least 2 Categories compared to baseline on 6-point ordinal CRS were reported. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening."}, {'measure': 'Percentage of Participants With All-cause Mortality Up to 28 Days', 'timeFrame': 'Up to 28 days', 'description': 'Percentage of participants with all-cause mortality up to 28 days were reported. All-cause mortality included all deaths of participants due to any cause.'}, {'measure': 'Time to Sustained Improvement of at Least 2 Categories on 6-point Ordinal CRS: Intent-to-Treat (ITT) Set', 'timeFrame': 'Up to Day 28', 'description': "Time to sustained improvement is defined as an improvement of at least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale, sustained until Day 28. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening."}, {'measure': 'Percentage of Participants With an Improvement of at Least 2 Categories Compared to Baseline on 6-point Ordinal CRS: ITT Set', 'timeFrame': 'Day 28', 'description': "Percentage of participants with an improvement of at least 2 categories compared to baseline on 6-point ordinal CRS were reported. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening."}, {'measure': 'Percentage of Participants With All-cause Mortality: ITT Set', 'timeFrame': 'Day 28', 'description': 'Percentage of participants with all-cause mortality were reported. All-cause mortality included all deaths of participants due to any cause.'}, {'measure': 'Percentage of Participants With Serious Adverse Events (SAEs) (Treatment Phase)', 'timeFrame': 'Up to Day 28', 'description': 'Percentage of participants with SAEs were reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.'}, {'measure': 'Percentage of Participants With Related Adverse Events (AEs)', 'timeFrame': 'Up to Day 28', 'description': 'Percentage of participants with related AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.'}, {'measure': 'Percentage of Participants With Severe or Life-threatening, Bacterial, Invasive Fungal, Viral or Opportunistic Infections', 'timeFrame': 'Up to Day 28', 'description': 'Percentage of participants with severe or Life-threatening, bacterial, invasive fungal, viral or opportunistic infections were reported.'}, {'measure': 'Percentage of Participants With Grade 3 and 4 Neutropenia and Lymphocytopenia', 'timeFrame': 'Up to Day 28', 'description': 'Percentage of participants with Grade 3 and 4 neutropenia and lymphocytopenia were reported. The laboratory abnormalities were determined as per division of microbiology and infectious diseases (DMID) adult toxicity as Grade 1: mild (transient or mild discomfort \\[less than {\\<} 48 hours\\]; no medical intervention/therapy required); Grade 2: moderate (mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required); Grade 3: severe (severe marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible); Grade 4: life-threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable).'}, {'measure': 'Percentage of Participants With Increased Alanine Transaminase (ALT) Greater Than or Equal to (>=)3*Upper Limit Normal (ULN) Combined With Increased Bilirubin Greater Than (>)2*ULN', 'timeFrame': 'Up to Day 28', 'description': 'Percentage of participants with increased ALT \\>=3\\*ULN combined with increased bilirubin \\>2\\*ULN were reported.'}, {'measure': 'Time to Sustained Improvement of at Least 1 Category on 6-point Ordinal CRS: Primary Analysis Set', 'timeFrame': 'Up to Day 28', 'description': "Time to sustained improvement is defined as an improvement of at least 1 category relative to baseline on the 6-point ordinal clinical recovery scale, sustained until Day 28. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening."}, {'measure': 'Time to Sustained Improvement of at Least 1 Category on 6-point Ordinal CRS: ITT Set', 'timeFrame': 'Up to Day 28', 'description': "Time to sustained improvement is defined as an improvement of at least 1 category relative to baseline on the 6-point ordinal clinical recovery scale, sustained until Day 28. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening."}, {'measure': 'Percentage of Participants With an Improvement of at Least 1 Category Compared to Baseline on 6-point Ordinal CRS: Primary Analysis Set', 'timeFrame': 'Day 28', 'description': "The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6), reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: (category 1) not hospitalized, including participants on low level of oxygen; Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening."}, {'measure': 'Percentage of Participants With an Improvement of at Least 1 Category on 6-point Ordinal CRS: ITT Set', 'timeFrame': 'Day 28', 'description': "The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening"}, {'measure': 'Time From Study Intervention Administration to End of Oxygen Supplementation', 'timeFrame': 'Up to Day 28', 'description': 'Time from study intervention administration to end of oxygen supplementation was reported.'}, {'measure': 'Time From Study Intervention Administration to Hospital Discharge Among the Surviving Participants', 'timeFrame': 'Up to Day 28', 'description': 'Time from study intervention administration to hospital discharge among the surviving participants was reported.'}, {'measure': 'Total Length of Hospitalization Among the Surviving Participants', 'timeFrame': 'Up to Day 28', 'description': 'Total length of hospitalization, defined as total duration of hospital stay, among the surviving participants was reported.'}, {'measure': 'Number of Ventilation Free Days', 'timeFrame': 'Up to Day 28', 'description': 'Number of ventilation free days in participants on invasive mechanical ventilation (IVM)/extracorporeal membrane oxygenation (ECMO) at baseline was reported.'}, {'measure': 'Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set', 'timeFrame': 'On Day 7, 14, 21, 28', 'description': "Percentage of participants with clinical status as assessed by 6-point Ordinal CRS were reported. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: Not hospitalized, not requiring supplemental oxygen (category 1.1); Not hospitalized, requiring supplemental oxygen (category 1.2); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening."}, {'measure': 'Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set', 'timeFrame': 'On Days 7, 14, 21, 28', 'description': "Percentage of participants with clinical status as assessed by 6-point Ordinal CRS (ITT Set) were reported. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: Not hospitalized, not requiring supplemental oxygen (category 1.1); Not hospitalized, requiring supplemental oxygen (category 1.2); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening."}, {'measure': 'Total Time on Invasive Mechanical Ventilation', 'timeFrame': 'Up to Day 28', 'description': 'Total time on invasive mechanical ventilation in participants who were on invasive mechanical ventilation at baseline was reported.'}, {'measure': 'Percentage of Participants With a Worse Category Relative to Baseline on the 6-point Ordinal CRS', 'timeFrame': 'From Day 5 up to Day 28', 'description': "Percentage of participants with a worse category relative to baseline on the 6-point ordinal CRS for at least one of the daily assessment during the reporting period Day 5 and Day 28 were reported. he 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening."}, {'measure': 'Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time', 'timeFrame': 'From Day 1 up to Day 28', 'description': 'Percentage of participants with ECMO over time were reported.'}, {'measure': 'Total Time on ECMO', 'timeFrame': 'Up to Day 28', 'description': 'Total time for participants on ECMO was reported.'}, {'measure': 'Percentage of Alive Participants at Day 28, Week 8, and Week 16', 'timeFrame': 'On Day 28, Week 8 and Week 16', 'description': 'Percentage of alive participants at Day 28, Week 8, and Week 16 were reported. For this outcome measure, at Week 8, data was not collected for participants due to pandemic situation.'}, {'measure': 'Percentage of Alive Participants That Required Readmission at Week 8, and Week 16', 'timeFrame': 'Week 8 and Week 16', 'description': 'Percentage of alive participants that required readmission at Week 8, and Week 16 were reported. For this outcome measure, at Week 8 and Week 16, data was not collected for participants due to pandemic situation.'}, {'measure': 'Percentage of Participants With SAEs (Follow-up Phase)', 'timeFrame': 'From Week 4 up to Week 16', 'description': 'Percentage of participants with SAEs were reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Confirmed Coronavirus Disease (COVID)-19']}, 'referencesModule': {'references': [{'pmid': '39362933', 'type': 'DERIVED', 'citation': 'Thys K, Loza MJ, Lynn L, Callewaert K, Varma L, Crabbe M, Van Wesenbeeck L, Van Landuyt E, De Meyer S, Aerssens J, Verbrugge I. Pharmacodynamic, prognostic, and predictive biomarkers in severe and critical COVID-19 patients treated with sirukumab. Sci Rep. 2024 Oct 3;14(1):22981. doi: 10.1038/s41598-024-74196-9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical response of sirukumab (administered as a single intravenous dose) plus standard of care (SOC) compared to placebo plus SOC in COVID-19.', 'detailedDescription': 'Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19), is an enveloped, positive-sense, single-stranded ribonucleic acid (RNA) betacoronavirus. Symptoms of COVID-19 infection may appear from 2 to 14 days following exposure, with the spectrum of illnesses ranging from mild symptoms to severe illness or death. The identification of SARS-CoV-2 follows the emergence of 2 other novel betacoronaviruses: SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV). Current management of COVID-19 is supportive, and respiratory failure from acute respiratory distress syndrome (ARDS) is the leading cause of mortality. While an understanding of the epidemiology and clinical spectrum of COVID-19 is still evolving during the ongoing pandemic, the current knowledge of the disease burden highlights the urgent medical need to develop a treatment. Sirukumab (also known as CNTO136) is a human anti-interleukin (IL)-6 immunoglobulin G1 kappa (IgG1k) monoclonal antibody (mAb). Sirukumab binds with high affinity and specificity to human IL-6 and as a result inhibits IL-6-mediated signaling and the biological effects of IL-6. The study will include a Screening Phase (up to 1 Day), a Treatment Phase (Day 1 to Day 28) and a Follow-up Phase (post Day 28, follow-up phone calls on Week 8, Week 12 and Week 16). Safety evaluations will include monitoring of adverse events and serious adverse events, physical examinations, vital sign measurements, electrocardiograms, clinical laboratory tests, pregnancy testing, and checking of vital status. The entire study duration for each participant will be 16 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Hospitalized\n* Has laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by real time-polymerase chain reaction (PCR) at any time before randomization\n* Evidence of infiltrates by chest X-ray, chest computed tomography (CT), lung ultrasound, or chest auscultation (rales, crackles)\n* Informed consent must be obtained from the participant indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study\n* Critical COVID-19 disease, defined as: Requires supplemental oxygen delivered by nonrebreather mask or high-flow nasal cannula or use of non-invasive or invasive ventilation or requiring treatment in an intensive care unit\n\n 1. AND corresponding to category 4 on the 6-point ordinal recovery scale, that is: requires one of the above modalities to sustain a peripheral capillary oxygen saturation (SpO2) greater than (\\>) 93 percent (%) with a fraction of inspired oxygen (FiO2) of 50% or higher. Note, the use of other devices may fit with category 4 if the FiO2 is 50% or higher.\n 2. OR, corresponding to category 5 on the 6-point ordinal recovery scale, that is partial pressure of oxygen in arterial per percentage of inspired oxygen (PaO2/FiO2) ratio \\< 300 millimeter of mercury (mmHg) while on invasive mechanical ventilation or veno-venous extracorporeal membrane oxygenation (ECMO) for less than 48 hours prior to screening\n\nExclusion Criteria:\n\n* On invasive mechanical ventilation or on veno-venous ECMO for \\>48 hours at time of screening\n* Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days before the planned dose of study intervention. Note: the investigator must ensure that the participant is not enrolled in another COVID-19 study with an investigational intervention (apart from the exception specified below) prior to completion of Day 28 of the current study. Exception: participation in a single arm study, a non-blinded controlled study, expanded access, compassionate use program or any other program that is not a blinded study is allowed if it is conducted with one of the following: agents with demonstrated in vitro-effect against SARSCoV- 2, as mentioned in the center of disease control and prevention (CDC) guidelines and convalescent plasma\n* Current confirmed or high suspicion for pulmonary embolus, hemodynamic significant pericardial effusion, myocarditis, or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification AND/OR Current evidence of active cardiac ischemia\n* Has a history of respiratory condition (that is, asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, fibrotic lung disease) that requires home oxygen supplementation, supportive non-invasive ventilation or, is status/post lung volume reduction surgery (LVRS). Exception: Participants with sleep apnea using supportive non-invasive ventilation (continuous positive airway pressure \\[CPAP\\]) at screening may be included\n* On renal replacement therapy (defined as peritoneal dialysis or hemodialysis)\n* Screening laboratory test result as follows: absolute neutrophil count (ANC) \\<1.0\\*10\\^3 cells/microliter; Platelet count \\<50\\*10\\^3 cells/microliter; estimated glomerular filtration rate (eGFR) \\<=30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\\^2); Bilirubin \\>2\\* upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin; alanine aminotransferase/ aspartate aminotransferase (ALT) \\>5\\*ULN; Prothrombin time (PT)/international normalized ratio (INR) \\>1.5\\*ULN or activated partial thromboplastin time (aPTT) \\>1.5\\*ULN related to known coagulopathy or bleeding disorder (the participant can receive anticoagulant therapies for underlying conditions, or as systematic thromboprophylaxis due to COVID-19, or as part of the treatment of complications of COVID-19, but cannot participate in a clinical study with anticoagulants for COVID-19)\n* Pregnant or breastfeeding, unless in the opinion of the investigator, the benefit outweighs the risks\n* Has active hepatitis B or C infection or has human immunodeficiency virus infection or acquired immune deficiency syndrome (HIV/AIDS) based on medical history and/or concomitant medication\n* Known active or latent tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB based on medical history and/or concomitant medication\n* Evidence of active bacterial (including but not limited to bacterial pneumonia), fungal, viral or opportunistic infection (other than SARS-CoV-2)\n* Currently active clinically significant (example, causing hemodynamic instability and/or causing hypoxemia) and uncontrolled arrhythmia"}, 'identificationModule': {'nctId': 'NCT04380961', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease (COVID)-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Pharmaceutica N.V., Belgium'}, 'officialTitle': 'Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical COVID-19 Disease', 'orgStudyIdInfo': {'id': 'CR108820'}, 'secondaryIdInfos': [{'id': 'CNTO136COV2001', 'type': 'OTHER', 'domain': 'Janssen Pharmaceutica N.V., Belgium'}, {'id': '2020-003056-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sirukumab', 'description': 'Participants will receive single intravenously (IV) dose infusion of sirukumab on Day 1 along with standard of care treatment.', 'interventionNames': ['Drug: Sirukumab', 'Other: Standard of Care (SOC)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive IV single dose infusion of placebo on Day 1 along with standard of care treatment.', 'interventionNames': ['Drug: Placebo', 'Other: Standard of Care (SOC)']}], 'interventions': [{'name': 'Sirukumab', 'type': 'DRUG', 'otherNames': ['CNTO136'], 'description': 'Participants will receive single dose infusion of sirukumab on Day 1.', 'armGroupLabels': ['Sirukumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive placebo IV single dose infusion on Day 1.', 'armGroupLabels': ['Placebo']}, {'name': 'Standard of Care (SOC)', 'type': 'OTHER', 'description': 'SOC treatment will be determined by the investigator based on local practice and consists of supportive care.', 'armGroupLabels': ['Placebo', 'Sirukumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "MemorialCare Research Miller Children's and Women's Hospital Long Beach", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Memorial Hospital', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Great Lakes Clinical Trials', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '61637', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois College of Medicine at Peoria', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '70012', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Sciences Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Beaumont Health Systems', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59701', 'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'facility': 'Mercury Street Medical Group, PLLC', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '07102', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Saint Michaels Medical Center - Infectious Disease', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White Research Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor All Saints Medical Center at Fort Worth', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Janssen Pharmaceutica N.V., Belgium Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Pharmaceutica N.V., Belgium'}]}, 'ipdSharingStatementModule': {'url': 'https://www.janssen.com/clinical-trials/transparency', 'ipdSharing': 'YES', 'description': 'The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \\& Johnson is available at www.janssen.com/clinical-trials/transparency.\n\nAs noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Pharmaceutica N.V., Belgium', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}