Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-29 @ 7:34 PM
Study NCT ID:
NCT04363203
Status:
SUSPENDED
Last Update Posted:
2020-06-22
First Post:
2020-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Eligible, consented patients will be randomized to a 1:1:1 treatment allocation, stratifying by age (\\<65, 65 or more) and region, and using randomly permutated blocks (block size of 3) within study site. Pharmacy is unblinded to study drugs.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin compared to placebo in treating mild to moderate COVID-19 among Veterans in the outpatient setting.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'whyStopped': 'concerns related to study drug', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-18', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-04-24', 'lastUpdatePostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days to resolution of cough, fever and shortness of breath', 'timeFrame': '30-days'}], 'secondaryOutcomes': [{'measure': 'Days to resolution of all COVID-19 symptoms', 'timeFrame': '30-days'}, {'measure': 'All cause hospitalization', 'timeFrame': '30-days'}, {'measure': 'All cause mortality', 'timeFrame': '30-days'}, {'measure': 'COVID-19 specific mortality', 'timeFrame': '30-days'}, {'measure': 'COVID-19 specific hospitalization', 'timeFrame': '30-days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV-2', 'COVID-19']}, 'referencesModule': {'references': [{'pmid': '34011199', 'type': 'DERIVED', 'citation': 'Keyhani S, Kelly JD, Bent S, Boscardin WJ, Shlipak MG, Leonard S, Abraham A, Lum E, Lau N, Austin C, Oldenburg CE, Zillich A, Lopez L, Zhang Y, Lietman T, Bravata DM. A telehealth-based randomized controlled trial: A model for outpatient trials of off-label medications during the COVID-19 pandemic. Clin Trials. 2021 Aug;18(4):514-517. doi: 10.1177/17407745211011577. Epub 2021 May 20.'}]}, 'descriptionModule': {'briefSummary': 'We propose a 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among Veterans in the outpatient setting.', 'detailedDescription': 'SARS-CoV-2 is a novel coronavirus disease (COVID-19) that presents with fever, cough, and shortness of breath, and has a mortality rate of 2-4%. Outcomes are worse among the elderly and those with cardiovascular, respiratory, cancer and other co-morbidities. Several treatments are also emerging as promising therapeutic candidates, hydroxychloroquine and azithromycin - both available as generic pills and widely used for other indications - are potential options for treatment. A small randomized controlled trial (RCT) of hospitalized patients suggests chloroquine may be superior to placebo in promoting viral elimination and shortening disease course. Hydroxychloroquine is preferred to chloroquine in the U.S. A small non-randomized trial found azithromycin had a clinical benefit. When azithromycin and hydroxychloroquine are given together, they can cause cardiac side-effects that limit use in the outpatient setting. These drugs, however, have independent potential benefits against COVID-19 that require more rigorous study before either is considered standard of care. We propose a 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among Veterans in the outpatient setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '216 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* willingness to take the study drug and ability to take oral medications\n* able to be contacted by phone\n* willing and able to give informed consent for participation in the study and agrees with its conduct and willing to email the study team a picture of their consent form\n\nExclusion Criteria:\n\nExclusion Criteria Based on National VA Data:\n\nWe will exclude individuals based on the following national VA data and chart review criteria:\n\n* eGFR \\<30mL/min or dialysis\n* aspartate transaminase (AST) or alanine transaminase (ALT) \\>5 times the upper limit of normal or cirrhosis in past 2 years\n* hypersensitivity to chloroquine, hydroxychloroquine or other 4-aminoquinolines (e.g., amodiaquine), azithromycin or macrolides\n* already taking hydroxychloroquine or azithromycin\n* congestive heart failure with an ejection fraction (EF) \\<35% in past 2 years or hospitalization within past 6 months\n* concomitant treatment with any QT prolonging drug\n* history of cardiac arrest, ventricular fibrillation or ventricular tachycardia in past 5 years\n* QT prolongation on any ECG in past 5 years\n* potassium \\<3.5 meq/l in labs in past 2 years\n* magnesium\\< 1/5 meq/l in any lab in past 2 years\n* any patient who has not had follow-up with their primary care doctors in past 2 years\n* any Veteran who cannot follow-up such as those with dementia, home based primary care or those with active psychosis documented in past 2 years\n* G6PD deficiency\n\nExclusions Based on Baseline Interview:\n\n* any female who is breastfeeding or pregnant or planning to become pregnant.\n* any Veteran who receives most of their care in non-VA settings\n* Veteran enrolled in another COVID Trial\n* Veteran received a prescription for azithromycin and hydroxychloroquine\n* Veteran allergic to azithromycin and or hydroxychloroquine\n* Veteran receiving QT prolonging drugs from non-VA pharmacy'}, 'identificationModule': {'nctId': 'NCT04363203', 'acronym': 'VA-REACH', 'briefTitle': 'VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)', 'organization': {'class': 'FED', 'fullName': 'San Francisco VA Health Care System'}, 'officialTitle': 'VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)', 'orgStudyIdInfo': {'id': '20-30517'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine: 2x200mg mg PO in the AM and 2x200mg PO in the PM on Day 1, followed by 200mg capsule in the AM and 200 mg in the PM on Days 2-5', 'interventionNames': ['Drug: Hydroxychloroquine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Azithromycin', 'description': 'Azithromycin: 2x250mg by mouth (PO) in the AM followed by 250mg PO every day on days 2-5', 'interventionNames': ['Drug: Azithromycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The pills packs for the 3 arms are identical.', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': 'Hydroxychloroquine: 2x200mg mg .PO in the AM and 2x200mg PO in the PM on Day 1, followed by 200mg PO in the AM and 200 mg PO in the PM on Days 2-5.', 'armGroupLabels': ['Hydroxychloroquine']}, {'name': 'Azithromycin', 'type': 'DRUG', 'description': 'Azithromycin: 2x250mg by mouth (PO) in the AM on Day 1, followed by 250mg PO every day on Days 2-5.', 'armGroupLabels': ['Azithromycin']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'Placebo in pill packs identical to study drugs', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco VA', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Salomeh Keyhani, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Francisco VA/University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salomeh Keyhani MD', 'class': 'FED'}, 'collaborators': [{'name': 'San Francisco VA Health Care System', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, University of California San Francisco', 'investigatorFullName': 'Salomeh Keyhani MD', 'investigatorAffiliation': 'San Francisco VA Health Care System'}}}}