Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-01 @ 7:41 PM
Study NCT ID:
NCT04336332
Status:
TERMINATED
Last Update Posted:
2023-02-28
First Post:
2020-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
Sponsor:
Organization:
Raw JSON
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'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'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hussaisa@rwjms.rutgers.edu', 'phone': '+1 732-718-3253', 'title': 'Dr. Sabiha Hussain', 'organization': 'Cancer Institute of New Jersey'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'The period of time over which adverse event data was collected is after six days.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Hydroxychloroquine Sulfate + Azithromycin', 'description': '* Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days\n* Azithromycin 500 mg taken by mouth on Day 1, followed by\n* Azithromycin 250 mg taken by mouth once (1) time a day for four (4) days.\n\nHydroxychloroquine Sulfate + Azithromycin: Given PO\n\nHydroxychloroquine Sulfate: Given PO', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 7, 'seriousNumAtRisk': 16, 'deathsNumAffected': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2: Hydroxychloroquine Sulfate Alone', 'description': '• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days\n\nHydroxychloroquine Sulfate: Given PO', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 13, 'seriousNumAtRisk': 30, 'deathsNumAffected': 4, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Arm 3: Placebo', 'description': '* Placebo pills Days 1-6.\n* If you still have COVID-19 symptoms you will receive Hydroxychloroquine sulfate 200 mg by mouth three (3) times a day for 10 days', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 5, 'seriousNumAtRisk': 29, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood and lymphatic system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Patients Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Hydroxychloroquine Sulfate + Azithromycin', 'description': '* Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days\n* Azithromycin 500 mg taken by mouth on Day 1, followed by\n* Azithromycin 250 mg taken by mouth once (1) time a day for four (4) days.\n\nHydroxychloroquine Sulfate + Azithromycin: Given PO\n\nHydroxychloroquine Sulfate: Given PO'}, {'id': 'OG001', 'title': 'Arm 2: Hydroxychloroquine Sulfate Alone', 'description': '• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days\n\nHydroxychloroquine Sulfate: Given PO'}, {'id': 'OG002', 'title': 'Arm 3: Placebo', 'description': '* Placebo pills Days 1-6.\n* If you still have COVID-19 symptoms you will receive Hydroxychloroquine sulfate 200 mg by mouth three (3) times a day for 10 days'}], 'timeFrame': 'Baseline and day six', 'description': 'Will be assessed at day six compared to baseline between hydroxychloroquine sulfate alone and hydroxychloroquine sulfate plus azithromycin to treat COVID-19.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Hydroxychloroquine Sulfate + Azithromycin', 'description': '* Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days\n* Azithromycin 500 mg taken by mouth on Day 1, followed by\n* Azithromycin 250 mg taken by mouth once (1) time a day for four (4) days.\n\nHydroxychloroquine Sulfate + Azithromycin: Given PO\n\nHydroxychloroquine Sulfate: Given PO'}, {'id': 'FG001', 'title': 'Arm 2: Hydroxychloroquine Sulfate Alone', 'description': '• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days\n\nHydroxychloroquine Sulfate: Given PO'}, {'id': 'FG002', 'title': 'Arm 3: Placebo', 'description': '* Placebo pills Days 1-6.\n* If you still have COVID-19 symptoms you will receive Hydroxychloroquine sulfate 200 mg by mouth three (3) times a day for 10 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: Hydroxychloroquine Sulfate + Azithromycin', 'description': '* Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days\n* Azithromycin 500 mg taken by mouth on Day 1, followed by\n* Azithromycin 250 mg taken by mouth once (1) time a day for four (4) days.\n\nHydroxychloroquine Sulfate + Azithromycin: Given PO\n\nHydroxychloroquine Sulfate: Given PO'}, {'id': 'BG001', 'title': 'Arm 2: Hydroxychloroquine Sulfate Alone', 'description': '• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days\n\nHydroxychloroquine Sulfate: Given PO'}, {'id': 'BG002', 'title': 'Arm 3: Placebo', 'description': '* Placebo pills Days 1-6.\n* If you still have COVID-19 symptoms you will receive Hydroxychloroquine sulfate 200 mg by mouth three (3) times a day for 10 days'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': 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'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-08', 'size': 20641070, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-20T14:54', 'hasProtocol': True}, {'date': '2020-05-08', 'size': 10238487, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-20T15:03', 'hasProtocol': False}, {'date': '2020-04-21', 'size': 9147982, 'label': 'Informed Consent Form: ICF #1', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-15T09:53', 'hasProtocol': False}, {'date': '2020-04-21', 'size': 2919449, 'label': 'Informed Consent Form: ICF #2', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-15T09:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'whyStopped': 'Ineffectiveness of treatment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-06', 'studyFirstSubmitDate': '2020-03-31', 'resultsFirstSubmitDate': '2022-10-14', 'studyFirstSubmitQcDate': '2020-04-02', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-06', 'studyFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Patients Viral Load', 'timeFrame': 'Baseline and day six', 'description': 'Will be assessed at day six compared to baseline between hydroxychloroquine sulfate alone and hydroxychloroquine sulfate plus azithromycin to treat COVID-19.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV-2', 'COVID-19']}, 'descriptionModule': {'briefSummary': 'This is a three-arm randomized trial comparing the efficacy of single agent hydroxychloroquine to the combination of hydroxychloroquine and azithromycin, and to a delayed hydroxychloroquine regimen, which will serve as a contemporaneous Day 1-6 supportive care control, in eliminating detectable SARS-CoV-2 on day 6 following the initiation of treatment in order to determine which regimen is more effective.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Determine change in viral load at day 6 compared to baseline between two regimens to treat COVID-19 and a contemporaneous control group.\n\nSECONDARY OBJECTIVES:\n\nI. Time to resolution of symptoms (symptom questionnaire)\n\nII. Change in the fever curve resulting in shorter time to afebrile for 48 hours\n\nIII. Normalization of vital signs\n\nIV. Time to discharge (if hospitalized)\n\nV. Assessment of agent toxicity as measured by standard metrics\n\nVI. Collection of throat swab and blood for viral load, presence of IgM or IgG antibodies\n\nVII. If feasible on samples collected for quantitative PCR decrease in virus shedding (in oropharyngeal secretions)\n\nVIII. Measures of cytokines in blood including IL6, IL-8, TNF, INF\n\nIX. Routine standard of care labs obtained as part of the care of these patients such as differential white count, CRP, troponin and LFTs will be analyzed for correlative trends'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with proven SARS-CoV-2 infection by an accepted assay with symptoms consistent with COVID-19\n* Ability to measure and quantify viral load by quantitative PCR\n* Age 18 to 89\n* Ability to swallow oral medications\n* Patients must read, understand and sign IRB approved informed consent\n\nExclusion Criteria:\n\n* Pregnancy or women who are breast feeding\n* Two consecutive negative assays for SARS-CoV-2 infection\n* Patients that lack decision-making capacity will not be approached to participate in this study\n* Inability to tolerate oral medications\n* Allergy or prior adverse reaction to either azithromycin or hydroxychloroquine sulfate\n* QTc interval \\> 470 mSEC\n* History of ongoing ventricular cardiac dysrhythmias of grade 2 as described by NCI CTCAE 5.0 criteria\n* History of serious ventricular arrhythmia (VT or VF \\> 3 beats in a row)'}, 'identificationModule': {'nctId': 'NCT04336332', 'briefTitle': 'Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19', 'orgStudyIdInfo': {'id': '002011'}, 'secondaryIdInfos': [{'id': 'Pro2020000712', 'type': 'OTHER', 'domain': 'Rutgers Health Sciences IRB'}, {'id': 'Pro2020000712', 'type': 'OTHER', 'domain': 'Rutgers Cancer Institute of New Jersey'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Hydroxychloroquine Sulfate + Azithromycin', 'description': '* Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days\n* Azithromycin 500 mg taken by mouth on Day 1, followed by\n* Azithromycin 250 mg taken by mouth once (1) time a day for four (4) days.', 'interventionNames': ['Combination Product: Hydroxychloroquine Sulfate + Azithromycin', 'Drug: Hydroxychloroquine Sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Hydroxychloroquine Sulfate alone', 'description': '• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days', 'interventionNames': ['Drug: Hydroxychloroquine Sulfate']}, {'type': 'NO_INTERVENTION', 'label': 'Arm 3: Placebo', 'description': '* Placebo pills Days 1-6.\n* If you still have COVID-19 symptoms you will receive Hydroxychloroquine sulfate 200 mg by mouth three (3) times a day for 10 days'}], 'interventions': [{'name': 'Hydroxychloroquine Sulfate + Azithromycin', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Hydroxychloroquine', 'Plaquenil', 'Z-Pak', 'Zithromax', 'Zmax'], 'description': 'Given PO', 'armGroupLabels': ['Arm 1: Hydroxychloroquine Sulfate + Azithromycin']}, {'name': 'Hydroxychloroquine Sulfate', 'type': 'DRUG', 'otherNames': ['Hydroxychloroquine', 'Plaquenil'], 'description': 'Given PO', 'armGroupLabels': ['Arm 1: Hydroxychloroquine Sulfate + Azithromycin', 'Arm 2: Hydroxychloroquine Sulfate alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07039', 'city': 'Livingston', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Saint Barnabas Medical Center', 'geoPoint': {'lat': 40.79593, 'lon': -74.31487}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Robert Wood Johnson University Hopsital', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The University Hospital', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '07112', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University Hospital-Newark', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}], 'overallOfficials': [{'name': 'Sabiha Hussain, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, The State University of New Jersey'}, {'name': 'Steven K. Libutti, MD, FACS', 'role': 'STUDY_CHAIR', 'affiliation': 'Rutgers Cancer Institute of New Jersey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Sabiha Hussain, MD,MPH', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}