Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-30 @ 2:50 AM
Study NCT ID:
NCT04340557
Status:
COMPLETED
Last Update Posted:
2021-05-26
First Post:
2020-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Do Angiotensin Receptor Blockers Mitigate Progression to Acute Respiratory Distress Syndrome With SARS-CoV-2 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019808', 'term': 'Losartan'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'matthew.geriak@sharp.com', 'phone': '858-939-3717', 'title': 'Matthew Geriak, PharmD', 'organization': 'Sharp HealthCare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The generalizability is limited by small size of the study population, unblinded design, and all the subjects being screened from three hospitals in close proximity in one geographic area in Southern California.'}}, 'adverseEventsModule': {'timeFrame': 'From enrollment into the study until hospital discharge or death, assessed up to 45 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Group A (Study Drug+SOC)', 'description': 'Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate.\n\nLosartan: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 3, 'seriousNumAtRisk': 16, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B (SOC)', 'description': 'Standard of Care', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 5, 'seriousNumAtRisk': 15, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypotension (SBP<100)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Body aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transaminitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Study Drug+SOC)', 'description': 'Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate.\n\nLosartan: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days.'}, {'id': 'OG001', 'title': 'Group B (SOC)', 'description': 'Standard of Care'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days', 'description': 'Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ICU Transfer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Study Drug+SOC)', 'description': 'Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate.\n\nLosartan: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days.'}, {'id': 'OG001', 'title': 'Group B (SOC)', 'description': 'Standard of Care'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days', 'description': 'Number of subjects transferred from non-ICU bed to an ICU bed', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oxygen Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Study Drug+SOC)', 'description': 'Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate.\n\nLosartan: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days.'}, {'id': 'OG001', 'title': 'Group B (SOC)', 'description': 'Standard of Care'}], 'classes': [{'categories': [{'measurements': [{'value': '10,469', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '49,968'}, {'value': '82,734', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '748,984'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days', 'description': 'Mean number of liters of oxygen consumed', 'unitOfMeasure': 'liters', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Study Drug+SOC)', 'description': 'Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate.\n\nLosartan: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days.'}, {'id': 'OG001', 'title': 'Group B (SOC)', 'description': 'Standard of Care'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '30'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '34'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days', 'description': 'Length of hospital stay from admission to discharge', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'In Hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Study Drug+SOC)', 'description': 'Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate.\n\nLosartan: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days.'}, {'id': 'OG001', 'title': 'Group B (SOC)', 'description': 'Standard of Care'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days', 'description': 'Number of subjects who expired while hospitalized', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Losartan + Standard of Care', 'description': 'Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate.\n\nLosartan: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days.'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Patient will receive the hospital Standard of Care for their condition'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Transferred to ICU and/or death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A (Study Drug+SOC)', 'description': 'Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate.\n\nLosartan: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days.'}, {'id': 'BG001', 'title': 'Group B (SOC)', 'description': 'Standard of Care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '95'}, {'value': '54.9', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '91'}, {'value': '57.1', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '95'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '95'}, {'value': '53', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '91'}, {'value': '53', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '95'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Black/African America', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Days from Hospital Admission to Enrollment', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Charlson Comorbidity Index', 'classes': [{'categories': [{'measurements': [{'value': '2.06', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '1.87', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '1.97', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'description': 'The revised Charlson Comorbidity Index is a weighted index to predict risk of death within 10 yrs for patients with specific comorbid conditions. 17 conditions were included in the revised index. Each condition was assigned from 0 to 6 and were summed to produce the score (https://www.mdcalc.com/charlson-comorbidity-index-cci) The lowest to highest possible score is 0 to 102. The higher the score indicates the higher probability of mortality. This scale was utilized to illustrate the clinical similarity between the two groups at baseline.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Comorbidities', 'classes': [{'title': 'Diabetes mellitus', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Obesity (BMI >/= 30 kg/m^2)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Tobacco Use', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Cardiovascular Disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Receipt of Concomitant SARS-CoV-2 Medications', 'classes': [{'title': 'Remdesivir', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Glucocorticoids > 2 doses', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Azithromycin', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Hydroxychloroquine', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Convalescent Plasma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Anti-thrombotics', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-20', 'size': 342588, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-10T16:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomized into one of two groups: Standard of Care or Standard of Care plus an ARB.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-24', 'studyFirstSubmitDate': '2020-04-06', 'resultsFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-24', 'studyFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of Hospital Stay', 'timeFrame': 'from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days', 'description': 'Length of hospital stay from admission to discharge'}, {'measure': 'In Hospital Mortality', 'timeFrame': 'from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days', 'description': 'Number of subjects who expired while hospitalized'}], 'primaryOutcomes': [{'measure': 'Mechanical Ventilation', 'timeFrame': 'from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days', 'description': 'Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure'}], 'secondaryOutcomes': [{'measure': 'ICU Transfer', 'timeFrame': 'from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days', 'description': 'Number of subjects transferred from non-ICU bed to an ICU bed'}, {'measure': 'Oxygen Therapy', 'timeFrame': 'from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days', 'description': 'Mean number of liters of oxygen consumed'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronavirus', 'Angiotensin receptor blocker', 'SARS-CoV-2', 'COVID-19'], 'conditions': ['SARS-CoV Infection']}, 'referencesModule': {'references': [{'pmid': '33977506', 'type': 'DERIVED', 'citation': 'Geriak M, Haddad F, Kullar R, Greenwood KL, Habib M, Habib C, Willms D, Sakoulas G. Randomized Prospective Open Label Study Shows No Impact on Clinical Outcome of Adding Losartan to Hospitalized COVID-19 Patients with Mild Hypoxemia. Infect Dis Ther. 2021 Sep;10(3):1323-1330. doi: 10.1007/s40121-021-00453-3. Epub 2021 May 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to identify whether or not Angiotensin Receptor Blockers (ARB) can halt the progression to respiratory failure requiring transfer into the intensive care unit (ICU), as well as halt mechanical ventilation in subjects with mild to moderate hypoxia due to the corona virus that causes COVID-19. Based on previous animal studies, the researchers hypothesize that the addition of an ARB is beneficial in abating acute lung injury in subjects in early stages of SARS-CoV-2 viral induced hypoxia.', 'detailedDescription': 'This is an investigator initiated, open label, multicenter, two arm, randomized study to compare the impact of adding an ARB to the Standard of Care (SOC) to the SOC without an ARB. Randomization ratio will be 1:1. The goal of this study is to identify whether or not ARBs have an impact on inhibiting the progression to respiratory failure requiring mechanical ventilation in patients with mild to moderate hypoxia in the setting of COVID-19. The addition of an ARB to the standard of care treatment for these patients may be beneficial in abating acute lung injury in patients in early stages of SARS-CoV-2 induced hypoxia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed COVID-19 positive test result\n* Mild to moderate respiratory symptoms of COVID-19.\n* Systolic blood pressure ≥ 105 mmHg.\n* Screen within 3 days of a positive COVID-19 test.\n* Age ≥18 years old.\n* Access to a phone in the hospital room or an electronic device that is capable of receiving phone or video calls.\n* Able to read/write/speak English or Spanish fluently.\n* Subjects must have the capacity to provide consent or an appropriate LAR to provide informed consent.\n* Negative pregnancy test for women of childbearing potential and subject is randomized to the study arm.\n\nExclusion Criteria:\n\n* Severe allergy to any ARB or ACE-inhibitor, including angioedema\n* In the intensive care unit at screening.\n* Home meds include any kind of ACE inhibitor or ARB\n* Acute Kidney Injury (50% reduction in GFR from baseline at admission to any time during treatment in the study treatment arm)\n* Hyperkalemia \\>5.0 mmol/L at baseline or any time during treatment in the study treatment arm\n* Creatinine Clearance \\< 30 ml/min at baseline or any time during treatment in the study treatment arm'}, 'identificationModule': {'nctId': 'NCT04340557', 'briefTitle': 'Do Angiotensin Receptor Blockers Mitigate Progression to Acute Respiratory Distress Syndrome With SARS-CoV-2 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Sharp HealthCare'}, 'officialTitle': 'Randomized Open Label Study of Standard of Care Plus an Angiotensin II Receptor Blocker Compared to Standard of Care Alone to Minimize the Progression to Respiratory Failure in SARS-CoV-2 Infection', 'orgStudyIdInfo': {'id': 'COVID-ARB'}, 'secondaryIdInfos': [{'id': '2003902', 'type': 'OTHER', 'domain': 'Sharp HealthCare Institutional Review Board (SHC IRB)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (Study drug+SOC)', 'description': 'Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate.', 'interventionNames': ['Drug: Losartan']}, {'type': 'NO_INTERVENTION', 'label': 'Group B (SOC)', 'description': 'Standard of Care'}], 'interventions': [{'name': 'Losartan', 'type': 'DRUG', 'otherNames': ['Losartan + Standard of Care'], 'description': "Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days. Upon the treating clinician's discretion, losartan may be continued beyond 10 days for non-COVID-19 indications.", 'armGroupLabels': ['Group A (Study drug+SOC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Grossmont Hospital', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '91911', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Chula Vista Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Memorial Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Matthew Geriak, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sharp HealthCare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sharp HealthCare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigational Pharmacist', 'investigatorFullName': 'Matthew Geriak', 'investigatorAffiliation': 'Sharp HealthCare'}}}}