Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
Study NCT ID:
NCT04308668
Status:
COMPLETED
Last Update Posted:
2021-05-13
First Post:
2020-03-11
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006886', 'term': 'Hydroxychloroquine'}], 'ancestors': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'covid19@umn.edu', 'phone': '6125552020', 'title': 'David Boulware, MD, MPH', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately 30-days', 'description': 'Reporting period was for onset of adverse events within 14 days. All hospitalizations were followed for up to 90 days for final resolution of outcome. Approximately 30 days was the maximal duration needed to capture final outcome.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'Participants in this arm will receive the study drug.\n\nHydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days', 'otherNumAtRisk': 658, 'deathsNumAtRisk': 658, 'otherNumAffected': 367, 'seriousNumAtRisk': 658, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive a placebo treatment.\n\nPlacebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days', 'otherNumAtRisk': 654, 'deathsNumAtRisk': 654, 'otherNumAffected': 148, 'seriousNumAtRisk': 654, 'deathsNumAffected': 1, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Nausea or upset stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numEvents': 146, 'numAffected': 146}, {'groupId': 'EG001', 'numAtRisk': 654, 'numEvents': 53, 'numAffected': 53}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea, abdominal pain, vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numEvents': 131, 'numAffected': 131}, {'groupId': 'EG001', 'numAtRisk': 654, 'numEvents': 35, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability, dizziness, vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numEvents': 39, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 654, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 654, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 654, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 654, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 654, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Taste change or dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 654, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction (non-anaphylaxis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 654, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flashes, night sweats, palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 654, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 654, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Panic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 654, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 654, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'COVID-related hospitalization', 'notes': 'n=5 vs. n=8 hospitalizations in early treatment population, n=1 vs. n=1 hospitalizations in postexposure prophylaxis population', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 654, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalizations not related to COVID or study medicine', 'notes': 'Adjudication was conducted by blinded investigators.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 654, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Active COVID-19 Disease at Day 14 Among Those Who Were Asymptomatic at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '414', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Participants in this arm will receive the study drug.\n\nHydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive a placebo treatment.\n\nPlacebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-7.0', 'ciUpperLimit': '2.2', 'estimateComment': 'Values represent percentages. Experimental treatment arm compared with the placebo control arm.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'Number of participants at 14 days post enrollment with active COVID19 disease among those who were asymptomatic at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Disease Severity Over 14 Days Among Those Who Are Symptomatic at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Participants in this arm will receive the study drug.\n\nHydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive a placebo treatment.\n\nPlacebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'spread': '.12', 'groupId': 'OG000'}, {'value': '-2.33', 'spread': '.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.117', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '0.27', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 14 days', 'description': 'Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '645', 'groupId': 'OG000'}, {'value': '641', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Participants in this arm will receive the study drug.\n\nHydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive a placebo treatment.\n\nPlacebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '645', 'groupId': 'OG000'}, {'value': '641', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Participants in this arm will receive the study drug.\n\nHydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive a placebo treatment.\n\nPlacebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 30 days', 'description': "Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease through study completion of 14 days. For those hospitalized within the 14-day study period, the protocol specified follow up would occur for up to 90 days to capture the final outcome of participants' hospitalization. Approximately 30-days was the maximal follow up for hospitalization outcome needed in the trial.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Confirmed SARS-CoV-2 Detection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '414', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Participants in this arm will receive the study drug.\n\nHydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive a placebo treatment.\n\nPlacebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'Outcome reported as the number of participants in each arm who have confirmed SARS-CoV-2 infection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Occurrence of Symptoms Compatible With COVID-19 (Possible Disease)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '414', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Participants in this arm will receive the study drug.\n\nHydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive a placebo treatment.\n\nPlacebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'Outcome reported as the number of participants in each arm who self-report symptoms compatible with COVID-19 infection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of All-Cause Study Medicine Discontinuation or Withdrawal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '645', 'groupId': 'OG000'}, {'value': '641', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Participants in this arm will receive the study drug.\n\nHydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive a placebo treatment.\n\nPlacebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Symptom Severity at 5 and 14 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Participants in this arm will receive the study drug.\n\nHydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive a placebo treatment.\n\nPlacebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days'}], 'classes': [{'title': 'Day 5', 'categories': [{'measurements': [{'value': '-2.22', 'groupId': 'OG000', 'lowerLimit': '-2.53', 'upperLimit': '-1.9'}, {'value': '-2.05', 'groupId': 'OG001', 'lowerLimit': '-2.37', 'upperLimit': '-1.73'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '-3.36', 'groupId': 'OG000', 'lowerLimit': '-3.62', 'upperLimit': '-3.09'}, {'value': '-3.08', 'groupId': 'OG001', 'lowerLimit': '-3.35', 'upperLimit': '-2.81'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 and 14 days', 'description': 'Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Early preemptive treatment trial (n=423 symptomatic participants with data)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Severe COVID-19 Disease at 14 Days Among Those Who Are Symptomatic at Trial Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Participants in this arm will receive the study drug.\n\nHydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive a placebo treatment.\n\nPlacebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the number of participants who report a score of 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Participants in this arm will receive the study drug.\n\nHydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive a placebo treatment.\n\nPlacebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '658'}, {'groupId': 'FG001', 'numSubjects': '654'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '622'}, {'groupId': 'FG001', 'numSubjects': '612'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '658', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1312', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Participants in this arm will receive the study drug.\n\nHydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive a placebo treatment.\n\nPlacebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '658', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1312', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '42', 'spread': '12', 'groupId': 'BG000'}, {'value': '42', 'spread': '12', 'groupId': 'BG001'}, {'value': '42', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Sex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '654', 'groupId': 'BG000'}, {'value': '650', 'groupId': 'BG001'}, {'value': '1304', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '354', 'groupId': 'BG000'}, {'value': '336', 'groupId': 'BG001'}, {'value': '690', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '314', 'groupId': 'BG001'}, {'value': '614', 'groupId': 'BG002'}]}]}, {'title': 'Non-binary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'While biological sex at birth was the question, 4 persons in each arm did not identify as male or female.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '658', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1312', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Asian/South Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '658', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1312', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '410', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '658', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1312', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '658', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1312', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '658', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1312', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '363', 'groupId': 'BG000'}, {'value': '379', 'groupId': 'BG001'}, {'value': '742', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '658', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1312', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'Middle Eastern', 'denoms': [{'units': 'Participants', 'counts': [{'value': '658', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1312', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Unknown/Not Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '658', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1312', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants could identify as more than one Race/Ethnicity', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '658', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1312', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '658', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1312', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '628', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1253', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-24', 'size': 1773568, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-02T09:49', 'hasProtocol': True}, {'date': '2020-04-24', 'size': 483118, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-06-02T14:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Asymptomatic participants are randomized and analyzed separate from symptomatic participants.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2020-03-11', 'resultsFirstSubmitDate': '2021-04-26', 'studyFirstSubmitQcDate': '2020-03-11', 'lastUpdatePostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-11', 'studyFirstPostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Active COVID-19 Disease at Day 14 Among Those Who Were Asymptomatic at Baseline', 'timeFrame': '14 days', 'description': 'Number of participants at 14 days post enrollment with active COVID19 disease among those who were asymptomatic at baseline.'}, {'measure': 'Change in Disease Severity Over 14 Days Among Those Who Are Symptomatic at Baseline', 'timeFrame': 'baseline and 14 days', 'description': 'Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)'}], 'secondaryOutcomes': [{'measure': 'Rate of Hospitalization', 'timeFrame': '14 days', 'description': 'Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.'}, {'measure': 'Rate of Death', 'timeFrame': 'Approximately 30 days', 'description': "Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease through study completion of 14 days. For those hospitalized within the 14-day study period, the protocol specified follow up would occur for up to 90 days to capture the final outcome of participants' hospitalization. Approximately 30-days was the maximal follow up for hospitalization outcome needed in the trial."}, {'measure': 'Rate of Confirmed SARS-CoV-2 Detection', 'timeFrame': '14 days', 'description': 'Outcome reported as the number of participants in each arm who have confirmed SARS-CoV-2 infection.'}, {'measure': 'Occurrence of Symptoms Compatible With COVID-19 (Possible Disease)', 'timeFrame': '14 days', 'description': 'Outcome reported as the number of participants in each arm who self-report symptoms compatible with COVID-19 infection.'}, {'measure': 'Rate of All-Cause Study Medicine Discontinuation or Withdrawal', 'timeFrame': '14 days', 'description': 'Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.'}, {'measure': 'Overall Symptom Severity at 5 and 14 Days', 'timeFrame': '5 and 14 days', 'description': 'Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)'}, {'measure': 'Number of Participants With Severe COVID-19 Disease at 14 Days Among Those Who Are Symptomatic at Trial Entry', 'timeFrame': '14 days', 'description': 'Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the number of participants who report a score of 3.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Corona Virus', 'SARS-COV-2', 'Coronavirus'], 'conditions': ['Corona Virus Infection', 'Acute Respiratory Distress Syndrome', 'SARS-CoV Infection', 'Coronavirus', 'Coronavirus Infections']}, 'referencesModule': {'availIpds': [{'url': 'http://www.covidpep.umn.edu/data', 'type': 'Individual Participant Data Set'}], 'references': [{'pmid': '32383125', 'type': 'BACKGROUND', 'citation': 'Lother SA, Abassi M, Agostinis A, Bangdiwala AS, Cheng MP, Drobot G, Engen N, Hullsiek KH, Kelly LE, Lee TC, Lofgren SM, MacKenzie LJ, Marten N, McDonald EG, Okafor EC, Pastick KA, Pullen MF, Rajasingham R, Schwartz I, Skipper CP, Turgeon AF, Zarychanski R, Boulware DR. Post-exposure prophylaxis or pre-emptive therapy for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): study protocol for a pragmatic randomized-controlled trial. Can J Anaesth. 2020 Sep;67(9):1201-1211. doi: 10.1007/s12630-020-01684-7. Epub 2020 May 7.'}, {'pmid': '32363212', 'type': 'BACKGROUND', 'citation': 'Pastick KA, Okafor EC, Wang F, Lofgren SM, Skipper CP, Nicol MR, Pullen MF, Rajasingham R, McDonald EG, Lee TC, Schwartz IS, Kelly LE, Lother SA, Mitja O, Letang E, Abassi M, Boulware DR. Review: Hydroxychloroquine and Chloroquine for Treatment of SARS-CoV-2 (COVID-19). Open Forum Infect Dis. 2020 Apr 15;7(4):ofaa130. doi: 10.1093/ofid/ofaa130. eCollection 2020 Apr.'}, {'pmid': '32344449', 'type': 'BACKGROUND', 'citation': 'Al-Kofahi M, Jacobson P, Boulware DR, Matas A, Kandaswamy R, Jaber MM, Rajasingham R, Young JH, Nicol MR. Finding the Dose for Hydroxychloroquine Prophylaxis for COVID-19: The Desperate Search for Effectiveness. Clin Pharmacol Ther. 2020 Oct;108(4):766-769. doi: 10.1002/cpt.1874. Epub 2020 Jun 1.'}, {'pmid': '32345336', 'type': 'BACKGROUND', 'citation': 'Ingraham NE, Boulware D, Sparks MA, Schacker T, Benson B, Sparks JA, Murray T, Connett J, Chipman JG, Charles A, Tignanelli CJ. Shining a light on the evidence for hydroxychloroquine in SARS-CoV-2. Crit Care. 2020 Apr 28;24(1):182. doi: 10.1186/s13054-020-02894-7. No abstract available.'}, {'pmid': '33553471', 'type': 'BACKGROUND', 'citation': 'Pullen MF, Pastick KA, Williams DA, Nascene AA, Bangdiwala AS, Okafor EC, Hullsiek KH, Skipper CP, Lofgren SM, Engen N, Abassi M, McDonald EG, Lee TC, Rajasingham R, Boulware DR. Lessons Learned From Conducting Internet-Based Randomized Clinical Trials During a Global Pandemic. Open Forum Infect Dis. 2020 Dec 28;8(2):ofaa602. doi: 10.1093/ofid/ofaa602. eCollection 2021 Feb.'}, {'pmid': '32668109', 'type': 'BACKGROUND', 'citation': 'Okafor EC, Pastick KA, Rajasingham R. Hydroxychloroquine as Postexposure Prophylaxis for Covid-19. Reply. N Engl J Med. 2020 Sep 10;383(11):1089. doi: 10.1056/NEJMc2023617. Epub 2020 Jul 15. No abstract available.'}, {'pmid': '32492293', 'type': 'RESULT', 'citation': 'Boulware DR, Pullen MF, Bangdiwala AS, Pastick KA, Lofgren SM, Okafor EC, Skipper CP, Nascene AA, Nicol MR, Abassi M, Engen NW, Cheng MP, LaBar D, Lother SA, MacKenzie LJ, Drobot G, Marten N, Zarychanski R, Kelly LE, Schwartz IS, McDonald EG, Rajasingham R, Lee TC, Hullsiek KH. A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19. N Engl J Med. 2020 Aug 6;383(6):517-525. doi: 10.1056/NEJMoa2016638. Epub 2020 Jun 3.'}, {'pmid': '32673060', 'type': 'RESULT', 'citation': 'Skipper CP, Pastick KA, Engen NW, Bangdiwala AS, Abassi M, Lofgren SM, Williams DA, Okafor EC, Pullen MF, Nicol MR, Nascene AA, Hullsiek KH, Cheng MP, Luke D, Lother SA, MacKenzie LJ, Drobot G, Kelly LE, Schwartz IS, Zarychanski R, McDonald EG, Lee TC, Rajasingham R, Boulware DR. Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial. Ann Intern Med. 2020 Oct 20;173(8):623-631. doi: 10.7326/M20-4207. Epub 2020 Jul 16.'}, {'pmid': '33204764', 'type': 'RESULT', 'citation': 'Lofgren SM, Nicol MR, Bangdiwala AS, Pastick KA, Okafor EC, Skipper CP, Pullen MF, Engen NW, Abassi M, Williams DA, Nascene AA, Axelrod ML, Lother SA, MacKenzie LJ, Drobot G, Marten N, Cheng MP, Zarychanski R, Schwartz IS, Silverman M, Chagla Z, Kelly LE, McDonald EG, Lee TC, Hullsiek KH, Boulware DR, Rajasingham R. Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19. Open Forum Infect Dis. 2020 Oct 19;7(11):ofaa500. doi: 10.1093/ofid/ofaa500. eCollection 2020 Nov.'}, {'pmid': '33721539', 'type': 'RESULT', 'citation': 'Skipper CP, Boulware DR. Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19. Ann Intern Med. 2021 Mar;174(3):434-435. doi: 10.7326/L20-1426. No abstract available.'}, {'pmid': '33274360', 'type': 'RESULT', 'citation': 'Nicol MR, Boulware DR, Rajasingham R. Reply to Neves. Clin Infect Dis. 2021 Oct 5;73(7):e1772-e1774. doi: 10.1093/cid/ciaa1809. No abstract available.'}, {'pmid': '33570583', 'type': 'DERIVED', 'citation': 'Akhtar S, Das JK, Ismail T, Wahid M, Saeed W, Bhutta ZA. Nutritional perspectives for the prevention and mitigation of COVID-19. Nutr Rev. 2021 Feb 11;79(3):289-300. doi: 10.1093/nutrit/nuaa063.'}]}, 'descriptionModule': {'briefSummary': 'Study Objective:\n\n1. To test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus.\n2. To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.', 'detailedDescription': 'Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging viral infection causing COVID19. The current strategy uses a public health model of identifying infected cases, isolation, and quarantine to stop transmission. Once exposed, observation is standard-of-care. Therapy is generally not given to persons who are not hospitalized. The doses of hydroxychloroquine being used are within the normal standard FDA-approved doses.\n\nHydroxychloroquine may have antiviral effects against SARS-COV2 which may prevent COVID-19 disease or early preemptive therapy may decrease disease severity. This trial will use a modification of standard malaria dosing of hydroxychloroquine to provide post-exposure prophylaxis to prevent disease or preemptive therapy for those with early symptoms. People around the the United States and Canada can participate to help answer this critically important question. No in-person visits are needed.\n\nThis trial is targeting 5 groups of people NATIONWIDE to participate:\n\n1. If you are symptomatic with a positive COVID-19 test within the first 4 days of symptoms and are not hospitalized; OR\n2. If you live with someone who has been diagnosed with COVID-19, with your last exposure within the last 4 days, and do not have any symptoms; OR\n3. If you live with someone who has been diagnosed with COVID-19, and your symptoms started within the last 4 days; OR\n4. If you have had occupational exposure with known exposure to someone with lab-confirmed COVID-19 within the last 4 days and do not have symptoms; OR\n5. If you have had occupational exposure with known exposure to someone with lab-confirmed COVID-19 within the last 4 days AND have compatible symptoms starting within the last 4 days;\n\nYou may participate if you live anywhere in the United States (including territories) or in the Canadian Provinces of Quebec, Manitoba, Alberta, or Ontario.\n\nFor information on how to participate in the research trial, go to covidpep.umn.edu or email covid19@umn.edu for instructions. Please check your spam folder if you email.\n\nIn Canada, for trial information, please go to: www.covid-19research.ca'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent\n* Exposure to a COVID19 case within 4 days as either a household contact or occupational exposure, OR\n* Symptomatic COVID19 case with confirmed diagnosis within 4 days of symptom onset OR symptomatic high risk exposure with known COVID19 contact and within 4 days of symptom onset;\n\nExclusion Criteria:\n\n* Current hospitalization\n* Allergy to hydroxychloroquine\n* Retinal eye disease\n* Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency\n* Known chronic kidney disease, stage 4 or 5 or receiving dialysis\n* Structural or ischemic heart disease\n* Personal or Family History of Prolonged QT syndrome\n* Weight \\< 50 kg\n* Known Porphyria\n* Current use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor; amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, Procanbid, propafenone, Rythmal, sotalol;\n* Current use of medicines which prolong the QT interval including:\n\n * Antimicrobials: levofloxacin, ciprofloxacin, moxifloxacin, azithromycin, clarithromycin, erythromycin, ketoconazole, itraconazole, or mefloquine\n * Antidepressants: amitriptyline, citalopram, desipramine, escitalopram, imipramine, doxepin, fluoxetine, wellbutrin, or venlafaxine\n * Antipsychotic or mood stabilizers: haloperidol, droperidol, lithium, quetiapine, thioridazine, ziprasidone\n * Methadone\n * Sumatriptan, zolmitriptan'}, 'identificationModule': {'nctId': 'NCT04308668', 'acronym': 'COVID-19 PEP', 'briefTitle': 'Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'MED-2020-28673'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Participants in this arm will receive the study drug.', 'interventionNames': ['Drug: Hydroxychloroquine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants in this arm will receive a placebo treatment.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Hydroxychloroquine', 'type': 'DRUG', 'otherNames': ['Plaquenil'], 'description': '200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days', 'armGroupLabels': ['Treatment']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Nationwide Enrollment via Internet, please email: covid19@umn.edu', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Institute of the McGill University Heath Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'David Boulware, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'url': 'https://covidpep.umn.edu/data', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'at time of publication', 'ipdSharing': 'YES', 'description': 'De-identified dataset will be available within 1 month of publication.', 'accessCriteria': 'To be publicly provided. Please register at the website to receive the dataset.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, {'name': 'University of Manitoba', 'class': 'OTHER'}, {'name': 'University of Alberta', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}