Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-28 @ 1:51 PM
Study NCT ID:
NCT04329832
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2020-03-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006886', 'term': 'Hydroxychloroquine'}, {'id': 'D017963', 'term': 'Azithromycin'}], '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'}, {'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': 'naresh.kumar@imail.org', 'phone': '8013827483', 'title': 'Naresh Kumar', 'organization': 'Intermountain Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Hospital discharge of the specific subject. Median length of stay for patients in both arms is 7.8 days. Upper bound of IQR for Hydroxychloroquine arm is 15.55 days and upper bound of IQR for Azithromycin arm is 20.85 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine: Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight \\< 45 kg or GFR (glomerular filtration rate)\\<50ml/min). For patients \\< 45kg, doses will be halved. For patients with GFR\\<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 3, 'seriousNumAtRisk': 42, 'deathsNumAffected': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Azithromycin', 'description': 'Azithromycin: Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 2, 'seriousNumAtRisk': 43, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'QT Prolongation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'COVID Ordinal Outcomes Scale at 14 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 14 WHO COVID Score: Hydroxychloroquine', 'description': 'The median WHO COVID Score at Day 14 for patients in the hydroxychloroquine arm'}, {'id': 'OG001', 'title': 'Day 14 WHO COVID Score: Azithromycin', 'description': 'The median WHO COVID Score at Day 14 for patients in the azithromycin arm'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '3.75'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed once on day 14 after enrollment (enrollment is day 0)', 'description': 'Improvement of clinical condition of the patient defined by the COVID-19 WHO ordinal Outcomes score. This scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital-free Days at 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': 'The median number of hospital-free days for hydroxychloroquine (Interquartile range)'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'The median number of hospital-free days for azithromycin (Interquartile range)'}], 'classes': [{'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '7.25', 'upperLimit': '24.75'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Admission (day 1) to 28 days after admission (day 28)', 'description': 'Calculated as number of days patient not in hospital', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ventilator-free Days at 28 Days (Number of Days Patient Not on a Ventilator)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ventilator-Free Days at Day 28 for Hydroxychloroquine Arm', 'description': 'Number of days that the patient is not on a ventilator up to 28 days following admission for patients in the Hydroxychloroquine Arm'}, {'id': 'OG001', 'title': 'Ventilator-Free Days at Day 28 for Azithromycin Arm', 'description': 'Number of days that the patient is not on a ventilator up to 28 days following admission for patients in the Azithromycin Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '10.75', 'upperLimit': '18'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Admission (day 1) to 28 days after admission (day 28)', 'description': 'Calculated as number of days that patient is not on a ventilator up to day 28 days after admission', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ICU-free Days at 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': 'The median ICU-free days for hydroxychloroquine (Interquartile Range)'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'The median ICU-free days for azithromycin (Interquartile Range)'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '22'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '22'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Admission (day 1) to 28 days after admission (day 28)', 'description': 'Calculated as number of days patient not in an ICU', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to a 1-point Decrease in the WHO Ordinal Recovery Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Days to a 1-point Decrease in WHO COVID Scale in Hydroxychloroquine Arm', 'description': 'Time (in days) until the ordinal outcome score drops by 1 relative to baseline on the 8-point WHO COVID Ordinal Outcomes scale for patients in the Hydroxychloroquine Arm.'}, {'id': 'OG001', 'title': 'Days to a 1-point Decrease in WHO COVID Scale in Azithromycin Arm', 'description': 'Time (in days) until the ordinal outcome score drops by 1 relative to baseline on the 8-point WHO COVID Ordinal Outcomes scale for patients in the Azithromycin Arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '13'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Admission (day 1) to 14 days after admission (day 14)', 'description': 'Time to 1-point decrease in the WHO ordinal recovery score is defined as the number of days until the ordinal outcome score drops by 1 relative to baseline on the 8-point WHO COVID Ordinal Outcomes scale, which reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine: Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight \\< 45 kg or GFR (glomerular filtration rate)\\<50ml/min). For patients \\< 45kg, doses will be halved. For patients with GFR\\<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.'}, {'id': 'FG001', 'title': 'Azithromycin', 'description': 'Azithromycin: Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine: Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight \\< 45 kg or GFR (glomerular filtration rate)\\<50ml/min). For patients \\< 45kg, doses will be halved. For patients with GFR\\<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.'}, {'id': 'BG001', 'title': 'Azithromycin', 'description': 'Azithromycin: Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '60'}, {'value': '58', 'groupId': 'BG001', 'lowerLimit': '43', 'upperLimit': '68'}, {'value': '55', 'groupId': 'BG002', 'lowerLimit': '42', 'upperLimit': '65'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', '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': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Comorbidities', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes found in administrative data, such as hospital abstracts data. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of 0 indicates no comorbidities were found. The higher the score (max 24) the more likely the predicted outcome will result in mortality or higher resource use.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-25', 'size': 855118, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-14T14:54', 'hasProtocol': True}, {'date': '2020-06-29', 'size': 206851, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-14T14:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-18', 'studyFirstSubmitDate': '2020-03-30', 'resultsFirstSubmitDate': '2022-03-14', 'studyFirstSubmitQcDate': '2020-03-30', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-18', 'studyFirstPostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID Ordinal Outcomes Scale at 14 Days', 'timeFrame': 'Assessed once on day 14 after enrollment (enrollment is day 0)', 'description': 'Improvement of clinical condition of the patient defined by the COVID-19 WHO ordinal Outcomes score. This scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".'}], 'secondaryOutcomes': [{'measure': 'Hospital-free Days at 28 Days', 'timeFrame': 'Admission (day 1) to 28 days after admission (day 28)', 'description': 'Calculated as number of days patient not in hospital'}, {'measure': 'Ventilator-free Days at 28 Days (Number of Days Patient Not on a Ventilator)', 'timeFrame': 'Admission (day 1) to 28 days after admission (day 28)', 'description': 'Calculated as number of days that patient is not on a ventilator up to day 28 days after admission'}, {'measure': 'ICU-free Days at 28 Days', 'timeFrame': 'Admission (day 1) to 28 days after admission (day 28)', 'description': 'Calculated as number of days patient not in an ICU'}, {'measure': 'Time to a 1-point Decrease in the WHO Ordinal Recovery Score', 'timeFrame': 'Admission (day 1) to 14 days after admission (day 14)', 'description': 'Time to 1-point decrease in the WHO ordinal recovery score is defined as the number of days until the ordinal outcome score drops by 1 relative to baseline on the 8-point WHO COVID Ordinal Outcomes scale, which reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'Hydroxychloroquine', 'Azithromycin'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'WHO, 2020. WHO R&D Blueprint, novel Coronavirus, COVID-19 Therapeutic Trial Synopsis. https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis'}, {'pmid': '35561317', 'type': 'DERIVED', 'citation': 'Koric A, Chang CP, Mark B, Rowe K, Snyder J, Dodson M, Deshmukh VG, Newman MG, Fraser AM, Smith KR, Date AP, Gren LH, Porucznik CA, Haaland BA, Henry NL, Hashibe M. Cardiovascular disease risk in long-term breast cancer survivors: A population-based cohort study. Cancer. 2022 Jul 15;128(14):2826-2835. doi: 10.1002/cncr.34224. Epub 2022 May 13.'}, {'pmid': '33166179', 'type': 'DERIVED', 'citation': 'Brown SM, Peltan I, Kumar N, Leither L, Webb BJ, Starr N, Grissom CK, Buckel WR, Srivastava R, Butler AM, Groat D, Haaland B, Ying J, Harris E, Johnson S, Paine R 3rd, Greene T. Hydroxychloroquine vs. Azithromycin for Hospitalized Patients with COVID-19 (HAHPS): Results of a Randomized, Active Comparator Trial. Ann Am Thorac Soc. 2020 Nov 9;18(4):590-7. doi: 10.1513/AnnalsATS.202008-940OC. Online ahead of print.'}, {'pmid': '32425051', 'type': 'DERIVED', 'citation': 'Brown SM, Peltan ID, Webb B, Kumar N, Starr N, Grissom C, Buckel WR, Srivastava R, Harris ES, Leither LM, Johnson SA, Paine R 3rd, Greene T. Hydroxychloroquine versus Azithromycin for Hospitalized Patients with Suspected or Confirmed COVID-19 (HAHPS). Protocol for a Pragmatic, Open-Label, Active Comparator Trial. Ann Am Thorac Soc. 2020 Aug;17(8):1008-1015. doi: 10.1513/AnnalsATS.202004-309SD.'}], 'seeAlsoLinks': [{'url': 'https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis', 'label': 'Source for WHO COVID Ordinal Outcomes Scale'}]}, 'descriptionModule': {'briefSummary': 'This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating hospitalized patients with suspected or confirmed COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (age ≥ 18 years)\n* Confirmed OR suspected COVID-19,\n\n * Confirmed: Positive assay for COVID-19 within the last 10 days\n * Suspected: Pending assay for COVID-19 WITH high clinical suspicion\n* Scheduled for admission or already admitted to an inpatient bed\n\nExclusion Criteria:\n\n* Allergy to hydroxychloroquine or azithromycin\n* History of bone marrow transplant\n* Known G6PD deficiency\n* Chronic hemodialysis or Glomerular Filtration Rate \\< 20ml/min\n* Psoriasis\n* Porphyria\n* Concomitant use of digitalis, flecainide, amiodarone, procainamide, propafenone, cimetidine, dofetilide, phenobarbital, phenytoin, or sotalol\n* Known history of long QT syndrome\n* Current known QTc\\>500 msec\n* Pregnant or nursing\n* Prisoner\n* Weight \\< 35kg\n* Seizure disorder\n* Severe liver disease\n* Outpatient use of hydroxychloroquine for treatment of a disease other than COVID-19 OR has received more than 2 days of hydroxychloroquine or azithromycin for suspected or confirmed COVID-19\n* Patient has recovered from COVID-19 and/or is being discharged from the hospital on day of enrollment.\n* Treating physician refuses to allow patient participation in the study\n* Unable to obtain informed consent\n* Prior enrollment in this study'}, 'identificationModule': {'nctId': 'NCT04329832', 'acronym': 'HAHPS', 'briefTitle': 'Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Intermountain Health Care, Inc.'}, 'officialTitle': 'Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19 (HAHPS): A Prospective Pragmatic Trial', 'orgStudyIdInfo': {'id': '1051355'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydroxychloroquine', 'interventionNames': ['Drug: Hydroxychloroquine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Azithromycin', 'interventionNames': ['Drug: Azithromycin']}], 'interventions': [{'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': 'Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight \\< 45 kg or GFR (glomerular filtration rate)\\<50ml/min). For patients \\< 45kg, doses will be halved. For patients with GFR\\<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.', 'armGroupLabels': ['Hydroxychloroquine']}, {'name': 'Azithromycin', 'type': 'DRUG', 'description': 'Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.', 'armGroupLabels': ['Azithromycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Samuel M Brown, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intermountain Health Care, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'In order to protect patient privacy and comply with relevant regulations, identified data are unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intermountain Health Care, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Utah', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Critical Care Research', 'investigatorFullName': 'Samuel Brown', 'investigatorAffiliation': 'Intermountain Health Care, Inc.'}}}}