Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-29 @ 4:20 PM
Study NCT ID:
NCT04328961
Status:
COMPLETED
Last Update Posted:
2021-12-16
First Post:
2020-03-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)
Sponsor:
Organization:
Raw JSON
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If participants were experiencing symptoms they were contacted by study staff for more information.', 'eventGroups': [{'id': 'EG000', 'title': 'Ascorbic Acid', 'description': 'Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days\n\nAscorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.', 'otherNumAtRisk': 422, 'deathsNumAtRisk': 422, 'otherNumAffected': 46, 'seriousNumAtRisk': 422, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Hydroxychloroquine', 'description': 'Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days\n\nHydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy', 'otherNumAtRisk': 407, 'deathsNumAtRisk': 407, 'otherNumAffected': 66, 'seriousNumAtRisk': 407, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhea, abdominal discomfort, or vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea or upset stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin reaction/rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurologic reaction: irritability, dizziness, or vertifgo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flashes, night sweats, or palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Taste change or dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ascorbic Acid', 'description': 'Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days\n\nAscorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.'}, {'id': 'OG001', 'title': 'Hydroxychloroquine', 'description': 'Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days\n\nHydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through Day 14 after enrolment', 'description': 'Polymerase chain reaction (PCR) confirmed severe acute respiratory syndrome coronavirus 2 of the genus Betacoronavirus (SARS-CoV-2) infection from self-collected samples collected daily for 14 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The above participants qualified for the Modified Intention-to-Treat Cohort'}, {'type': 'PRIMARY', 'title': 'The Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ascorbic Acid', 'description': 'Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days\n\nAscorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.'}, {'id': 'OG001', 'title': 'Hydroxychloroquine', 'description': 'Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days\n\nHydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28 after enrolment', 'description': 'Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Participant-reported Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ascorbic Acid', 'description': 'Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days\n\nAscorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.'}, {'id': 'OG001', 'title': 'Hydroxychloroquine', 'description': 'Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days\n\nHydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days from start of Hydroxychloroquine therapy', 'description': 'Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had COVID-19 Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ascorbic Acid', 'description': 'Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days\n\nAscorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.'}, {'id': 'OG001', 'title': 'Hydroxychloroquine', 'description': 'Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days\n\nHydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days from enrolment', 'description': 'Participants who had a PCR-confirmed SARS-CoV-2 infection and met the Center for Disease Control (CDC) defined criteria for symptomatic COVID-19 disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ascorbic Acid', 'description': 'Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days\n\nAscorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.'}, {'id': 'FG001', 'title': 'Hydroxychloroquine', 'description': 'Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days\n\nHydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '422'}, {'groupId': 'FG001', 'numSubjects': '407'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '336'}, {'groupId': 'FG001', 'numSubjects': '353'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '54'}]}]}], 'preAssignmentDetails': '949 participants were assessed for eligibility, 114 were excluded and 829 were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'BG000'}, {'value': '353', 'groupId': 'BG001'}, {'value': '689', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ascorbic Acid', 'description': 'Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days\n\nAscorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.'}, {'id': 'BG001', 'title': 'Hydroxychloroquine', 'description': 'Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days\n\nHydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy'}, {'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': '307', 'groupId': 'BG000'}, {'value': '322', 'groupId': 'BG001'}, {'value': '629', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '50'}, {'value': '40', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '51'}, {'value': '39', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '51'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '412', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '250', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '534', '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': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '336', 'groupId': 'BG000'}, {'value': '353', 'groupId': 'BG001'}, {'value': '689', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The above participants contributed to the Modified Intention-to-Treat Cohort.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-09', 'size': 910056, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-08T11:13', 'hasProtocol': True}, {'date': '2020-08-22', 'size': 299543, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-08T11:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 943}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-14', 'studyFirstSubmitDate': '2020-03-23', 'resultsFirstSubmitDate': '2021-10-08', 'studyFirstSubmitQcDate': '2020-03-29', 'lastUpdatePostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-14', 'studyFirstPostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection', 'timeFrame': 'Day 1 through Day 14 after enrolment', 'description': 'Polymerase chain reaction (PCR) confirmed severe acute respiratory syndrome coronavirus 2 of the genus Betacoronavirus (SARS-CoV-2) infection from self-collected samples collected daily for 14 days'}, {'measure': 'The Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection', 'timeFrame': 'Day 28 after enrolment', 'description': 'Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit'}], 'secondaryOutcomes': [{'measure': 'Rate of Participant-reported Adverse Events', 'timeFrame': '28 days from start of Hydroxychloroquine therapy', 'description': 'Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults'}, {'measure': 'Number of Participants Who Had COVID-19 Disease', 'timeFrame': '28 days from enrolment', 'description': 'Participants who had a PCR-confirmed SARS-CoV-2 infection and met the Center for Disease Control (CDC) defined criteria for symptomatic COVID-19 disease.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['novel coronavirus', 'post-exposure prophylaxis'], 'conditions': ['COVID-19', 'Corona Virus Infection', 'SARS (Severe Acute Respiratory Syndrome)', 'SARS-CoV-2']}, 'referencesModule': {'references': [{'pmid': '33284679', 'type': 'DERIVED', 'citation': 'Barnabas RV, Brown ER, Bershteyn A, Stankiewicz Karita HC, Johnston C, Thorpe LE, Kottkamp A, Neuzil KM, Laufer MK, Deming M, Paasche-Orlow MK, Kissinger PJ, Luk A, Paolino K, Landovitz RJ, Hoffman R, Schaafsma TT, Krows ML, Thomas KK, Morrison S, Haugen HS, Kidoguchi L, Wener M, Greninger AL, Huang ML, Jerome KR, Wald A, Celum C, Chu HY, Baeten JM; Hydroxychloroquine COVID-19 PEP Study Team. Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection : A Randomized Trial. Ann Intern Med. 2021 Mar;174(3):344-352. doi: 10.7326/M20-6519. Epub 2020 Dec 8.'}, {'pmid': '32493478', 'type': 'DERIVED', 'citation': 'Barnabas RV, Brown E, Bershteyn A, Miller RS, Wener M, Celum C, Wald A, Chu H, Wesche D, Baeten JM; Hydroxychloroquine COVID-19 PEP Study Team. Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 3;21(1):475. doi: 10.1186/s13063-020-04446-4.'}]}, 'descriptionModule': {'briefSummary': 'This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or clinically suspected COVID-19. Eligible participants will be enrolled and randomized to receive the intervention or placebo at the level of the household (all eligible participants in one household will receive the same intervention).', 'detailedDescription': 'This is a randomized, multi-center, placebo-equivalent (ascorbic acid) controlled, blinded study of Hydroxychloroquine (HCQ) post-exposure prophylaxis (PEP) for the prevention of SARS-CoV-2 infection in adults exposed to the virus.The overarching goal of this study is to assess the effectiveness of HCQ PEP on the incidence of SARS-CoV-2 detection by polymerase chain reaction (PCR) to inform public health control strategies.This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with PCR-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test. Eligible participants will be enrolled and randomized 1:1 to HCQ or ascorbic acid at the level of the household (all eligible participants in one household will receive the same intervention). Participants will be counseled about the preliminary in vitro data on HCQ activity against SARS CoV-2 and equipoise regarding efficacy in humans.The duration of study participation will be approximately 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women 18 to 80 years of age inclusive, at the time of signing the informed consent\n* Willing and able to provide informed consent\n* Had a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or who is currently being assessed for COVID-19. Close contact defined as:\n\n 1. Household contact (i.e., residing with the index case in the 14 days prior to index diagnosis)\n 2. Medical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)\n* Less than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection) to the index case\n* Body weight \\< 100 kg (self-reported)\n* Access to device and internet for Telehealth visits\n\nExclusion Criteria:\n\n* Known hypersensitivity to HCQ or other 4-aminoquinoline compounds\n* Currently hospitalized\n* Symptomatic with subjective fever, cough, or sore throat\n* Current medications exclude concomitant use of HCQ\n* Concomitant use of other anti-malarial treatment or chemoprophylaxis\n* History of retinopathy of any etiology\n* Psoriasis\n* Porphyria\n* Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes \\< 1500) or thrombocytopenia (\\< 100 K)\n* Concomitant use of digoxin, cyclosporin, cimetidine, or tamoxifen\n* Known liver disease\n* Known long QT syndrome\n* Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs, or planned use during the study period'}, 'identificationModule': {'nctId': 'NCT04328961', 'briefTitle': 'Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Efficacy of Hydroxychloroquine for Post-exposure Prophylaxis (PEP) to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Adults Exposed to Coronavirus Disease (COVID-19): a Blinded, Randomized Study', 'orgStudyIdInfo': {'id': 'STUDY00009750'}, 'secondaryIdInfos': [{'id': 'INV-016204', 'type': 'OTHER_GRANT', 'domain': 'Bill and Melinda Gates Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Ascorbic Acid', 'description': 'Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days', 'interventionNames': ['Drug: Ascorbic Acid']}, {'type': 'EXPERIMENTAL', 'label': 'Hydroxychloroquine', 'description': 'Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days', 'interventionNames': ['Drug: Hydroxychloroquine Sulfate']}], 'interventions': [{'name': 'Hydroxychloroquine Sulfate', 'type': 'DRUG', 'otherNames': ['HCQ arm'], 'description': 'Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy', 'armGroupLabels': ['Hydroxychloroquine']}, {'name': 'Ascorbic Acid', 'type': 'DRUG', 'otherNames': ['Placebo arm'], 'description': 'Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.', 'armGroupLabels': ['Ascorbic Acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '70118', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland, Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington, Coordinating Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'UW Virology Research Clinic', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Ruanne V. Barnabas, MBChB, DPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'url': 'https://www.gatesfoundation.org/how-we-work/general-information/open-access-policy', 'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Within 3 months of publication of primary results.', 'ipdSharing': 'YES', 'description': "De-identified data from the study will be made available in accordance with the funder's open access policy.", 'accessCriteria': "De-identified data from the study will be made available in accordance with the funder's open access policy."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, School of Medicine: Global Health', 'investigatorFullName': 'Ruanne Barnabas', 'investigatorAffiliation': 'University of Washington'}}}}