Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT04328467
Status:
COMPLETED
Last Update Posted:
2021-07-02
First Post:
2020-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pre-exposure Prophylaxis for SARS-Coronavirus-2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': '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': 'radha@umn.edu', 'phone': '612-626-8171', 'title': 'Radha Rajasingham, MD', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Once Weekly', 'description': '400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral', 'otherNumAtRisk': 494, 'deathsNumAtRisk': 494, 'otherNumAffected': 0, 'seriousNumAtRisk': 494, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Intervention Twice Weekly', 'description': '400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral', 'otherNumAtRisk': 495, 'deathsNumAtRisk': 495, 'otherNumAffected': 0, 'seriousNumAtRisk': 495, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Control Group', 'description': 'Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks\n\nPlacebo: Placebo; tablet; oral', 'otherNumAtRisk': 494, 'deathsNumAtRisk': 494, 'otherNumAffected': 0, 'seriousNumAtRisk': 494, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'seriousEvents': [{'term': 'Hysteroscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spinal Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elective Coronary Angiogram', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gall Bladder Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 494, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Motor Vehicle Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 494, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 494, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 494, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperthyroid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 494, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 494, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sarcoidosis Biopsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 494, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Not Specified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 494, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'COVID-19-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}, {'value': '494', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Once Weekly', 'description': '400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'OG001', 'title': 'Intervention Twice Weekly', 'description': '400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks\n\nPlacebo: Placebo; tablet; oral'}], 'classes': [{'categories': [{'measurements': [{'value': '464', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}, {'value': '454', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 12 weeks', 'description': 'Outcome reported as the number of participants in each arm who are COVID-19-free at the end of study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Confirmed SARS-CoV-2 Detection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}, {'value': '494', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Once Weekly', 'description': '400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'OG001', 'title': 'Intervention Twice Weekly', 'description': '400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks\n\nPlacebo: Placebo; tablet; oral'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 12 weeks', 'description': 'Outcome reported as the number of participants in each arm who have a confirmed SARS-CoV-2 infection during study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Possible COVID-19 Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}, {'value': '494', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Once Weekly', 'description': '400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'OG001', 'title': 'Intervention Twice Weekly', 'description': '400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks\n\nPlacebo: Placebo; tablet; oral'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 12 weeks', 'description': 'Outcome reported as the count of participants in each arm who report COVID-19-related symptoms during study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of All-cause Study Medicine Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}, {'value': '494', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Once Weekly', 'description': '400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'OG001', 'title': 'Intervention Twice Weekly', 'description': '400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks\n\nPlacebo: Placebo; tablet; oral'}], 'classes': [{'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 12 weeks', 'description': 'Outcome reported as the count of participants in each arm who discontinue study medication use for any reason during treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ordinal Scale of COVID-19 Disease Maximum Severity if COVID-19 Diagnosed at Study End', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Once Weekly', 'description': '400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'OG001', 'title': 'Intervention Twice Weekly', 'description': '400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks\n\nPlacebo: Placebo; tablet; oral'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'Only one data point was collected, therefore a measure of dispersion could not be calculated.', 'groupId': 'OG001'}, {'value': '1', 'spread': 'NA', 'comment': 'Only one data point was collected, therefore a measure of dispersion could not be calculated.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 12 weeks', 'description': 'Participants will self-report COVID-19 status on an ordinal scale as follows: No illness (score=1), Illness with outpatient observation (score=2), Hospitalization (or post-hospital discharge) (score=3), or Hospitalization with ICU stay or death (score=4). Possible scores range from 1-4 with higher scores indicating greater disease severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Measure was only collected for one participant in the twice-weekly intervention group and one participant in the control group. No participants in the once-weekly intervention group were sampled for this measure.'}, {'type': 'SECONDARY', 'title': 'Incidence of Hospitalization for COVID-19 or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}, {'value': '494', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Once Weekly', 'description': '400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'OG001', 'title': 'Intervention Twice Weekly', 'description': '400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks\n\nPlacebo: Placebo; tablet; oral'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 12 weeks', 'description': 'Outcome reported as the number of participants in each arm who are hospitalized or expire due to COVID-19 during study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Possible Study Medication-related Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}, {'value': '494', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Once Weekly', 'description': '400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'OG001', 'title': 'Intervention Twice Weekly', 'description': '400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks\n\nPlacebo: Placebo; tablet; oral'}], 'classes': [{'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 12 weeks', 'description': 'Outcome reported as the number of participants in each arm who experience possible medication-related side effects during study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Once Weekly', 'description': '400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'FG001', 'title': 'Intervention Twice Weekly', 'description': '400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks\n\nPlacebo: Placebo; tablet; oral'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '494'}, {'groupId': 'FG001', 'numSubjects': '495'}, {'groupId': 'FG002', 'numSubjects': '494'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '490'}, {'groupId': 'FG001', 'numSubjects': '493'}, {'groupId': 'FG002', 'numSubjects': '493'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Did not meet inclusion criteria after randomization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'BG000'}, {'value': '495', 'groupId': 'BG001'}, {'value': '494', 'groupId': 'BG002'}, {'value': '1483', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Once Weekly', 'description': '400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'BG001', 'title': 'Intervention Twice Weekly', 'description': '400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks\n\nHydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks\n\nPlacebo: Placebo; tablet; oral'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000', 'lowerLimit': '35', 'upperLimit': '49'}, {'value': '41', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '49'}, {'value': '40', 'groupId': 'BG002', 'lowerLimit': '34', 'upperLimit': '48'}, {'value': '41', 'groupId': 'BG003', 'lowerLimit': '35', 'upperLimit': '48'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '261', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}, {'value': '760', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}, {'value': '723', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '431', 'groupId': 'BG000'}, {'value': '421', 'groupId': 'BG001'}, {'value': '419', 'groupId': 'BG002'}, {'value': '1271', 'groupId': 'BG003'}]}]}, {'title': 'Black of African', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}, {'title': 'Native American or Alaska Native', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'Middle Eastern', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'South Asian', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '493', 'groupId': 'BG000'}, {'value': '494', 'groupId': 'BG001'}, {'value': '493', 'groupId': 'BG002'}, {'value': '1480', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-27', 'size': 547672, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-25T12:27', 'hasProtocol': True}, {'date': '2020-04-01', 'size': 215644, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-05-05T14:24', '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1483}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-30', 'studyFirstSubmitDate': '2020-03-27', 'resultsFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2020-03-30', 'lastUpdatePostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-25', 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID-19-free Survival', 'timeFrame': 'up to 12 weeks', 'description': 'Outcome reported as the number of participants in each arm who are COVID-19-free at the end of study treatment.'}], 'secondaryOutcomes': [{'measure': 'Number of Confirmed SARS-CoV-2 Detection', 'timeFrame': 'up to 12 weeks', 'description': 'Outcome reported as the number of participants in each arm who have a confirmed SARS-CoV-2 infection during study treatment.'}, {'measure': 'Incidence of Possible COVID-19 Symptoms', 'timeFrame': 'up to 12 weeks', 'description': 'Outcome reported as the count of participants in each arm who report COVID-19-related symptoms during study treatment.'}, {'measure': 'Incidence of All-cause Study Medicine Discontinuation', 'timeFrame': 'up to 12 weeks', 'description': 'Outcome reported as the count of participants in each arm who discontinue study medication use for any reason during treatment.'}, {'measure': 'Ordinal Scale of COVID-19 Disease Maximum Severity if COVID-19 Diagnosed at Study End', 'timeFrame': 'up to 12 weeks', 'description': 'Participants will self-report COVID-19 status on an ordinal scale as follows: No illness (score=1), Illness with outpatient observation (score=2), Hospitalization (or post-hospital discharge) (score=3), or Hospitalization with ICU stay or death (score=4). Possible scores range from 1-4 with higher scores indicating greater disease severity.'}, {'measure': 'Incidence of Hospitalization for COVID-19 or Death', 'timeFrame': 'up to 12 weeks', 'description': 'Outcome reported as the number of participants in each arm who are hospitalized or expire due to COVID-19 during study treatment.'}, {'measure': 'Incidence of Possible Study Medication-related Side Effects', 'timeFrame': 'up to 12 weeks', 'description': 'Outcome reported as the number of participants in each arm who experience possible medication-related side effects during study treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Corona Virus Infection', 'ARDS', 'Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '33068425', 'type': 'RESULT', 'citation': 'Rajasingham R, Bangdiwala AS, Nicol MR, Skipper CP, Pastick KA, Axelrod ML, Pullen MF, Nascene AA, Williams DA, Engen NW, Okafor EC, Rini BI, Mayer IA, McDonald EG, Lee TC, Li P, MacKenzie LJ, Balko JM, Dunlop SJ, Hullsiek KH, Boulware DR, Lofgren SM; COVID PREP team. Hydroxychloroquine as Pre-exposure Prophylaxis for Coronavirus Disease 2019 (COVID-19) in Healthcare Workers: A Randomized Trial. Clin Infect Dis. 2021 Jun 1;72(11):e835-e843. doi: 10.1093/cid/ciaa1571.'}, {'pmid': '33204764', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.', 'detailedDescription': 'The current standard of care is observation and quarantine after exposure to COVID-19. There is no approved treatment or prophylaxis for COVID-19.\n\nAs of March 6, 2020, the CDC estimates that the transmission of SARS-CoV2 after a U.S. household close contract is 10.5% (95%CI, 2.9 to 31.4%). Among all close contacts, the SARS-CoV2 transmission rate is estimated at 0.45% (95%CI, 0.12 to 1.6%) by the CDC. These estimates are based on monitoring of travel-associated COVID19 cases. Conversely, in a setting with community transmission, the secondary attack rate in China was 35% (95%CI, 27-44%) based on 48 transmissions among 137 persons in 9 index patients.\n\nChloroquine or Hydroxychloroquine may have antiviral effects against SARS-COV2 which may prevent COVID-19 disease or reduce disease severity. It is not known at what dosing hydroxychloroquine may be effective for pre-exposure prophylaxis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- A healthcare worker at high risk for COVID-19 exposure (defined below):\n\n* Persons primarily working in emergency departments (physicians, nurses, ancillary staff, triage personnel)\n* Persons primarily working in intensive care units (physicians, nurses, ancillary staff, respiratory therapists)\n* Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse anesthetists (CRNAs)\n* First responders (i.e. EMTs, paramedics)\n\nExclusion Criteria:\n\n* Active COVID-19 disease\n* Prior COVID-19 disease\n* Current fever, cough, shortness of breath\n* Allergy to chloroquine or hydroxychloroquine\n* Prior retinal eye disease\n* Known Chronic Kidney disease, Stage 4 or 5 or dialysis\n* Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency\n* Weight \\<40 kg\n* Prolonged QT syndrome\n* Current use of hydroxychloroquine, chloroquine, or cardiac medicines of flecainide, amiodarone, digoxin, procainamide, or propafenone\n* Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen, or methotrexate.'}, 'identificationModule': {'nctId': 'NCT04328467', 'briefTitle': 'Pre-exposure Prophylaxis for SARS-Coronavirus-2', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Pre-exposure Prophylaxis for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'MED-2020-28720'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Once Weekly', 'description': '400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks', 'interventionNames': ['Drug: Hydroxychloroquine']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Twice Weekly', 'description': '400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks', 'interventionNames': ['Drug: Hydroxychloroquine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Hydroxychloroquine', 'type': 'DRUG', 'otherNames': ['Plaquenil'], 'description': 'Hydroxychloroquine; 200mg tablet; oral', 'armGroupLabels': ['Intervention Once Weekly', 'Intervention Twice Weekly']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo; tablet; oral', 'armGroupLabels': ['Control Group']}]}, '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}}], 'overallOfficials': [{'name': 'Radha Rajasingham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}