Status:
SUSPENDED
VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)
Lead Sponsor:
Salomeh Keyhani MD
Collaborating Sponsors:
San Francisco VA Health Care System
Conditions:
SARS-CoV-2
COVID-19
Eligibility:
All Genders
216+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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 car...
Eligibility Criteria
Inclusion
- willingness to take the study drug and ability to take oral medications
- able to be contacted by phone
- 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
Exclusion
- Exclusion Criteria Based on National VA Data:
- We will exclude individuals based on the following national VA data and chart review criteria:
- eGFR \<30mL/min or dialysis
- aspartate transaminase (AST) or alanine transaminase (ALT) \>5 times the upper limit of normal or cirrhosis in past 2 years
- hypersensitivity to chloroquine, hydroxychloroquine or other 4-aminoquinolines (e.g., amodiaquine), azithromycin or macrolides
- already taking hydroxychloroquine or azithromycin
- congestive heart failure with an ejection fraction (EF) \<35% in past 2 years or hospitalization within past 6 months
- concomitant treatment with any QT prolonging drug
- history of cardiac arrest, ventricular fibrillation or ventricular tachycardia in past 5 years
- QT prolongation on any ECG in past 5 years
- potassium \<3.5 meq/l in labs in past 2 years
- magnesium\< 1/5 meq/l in any lab in past 2 years
- any patient who has not had follow-up with their primary care doctors in past 2 years
- 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
- G6PD deficiency
- Exclusions Based on Baseline Interview:
- any female who is breastfeeding or pregnant or planning to become pregnant.
- any Veteran who receives most of their care in non-VA settings
- Veteran enrolled in another COVID Trial
- Veteran received a prescription for azithromycin and hydroxychloroquine
- Veteran allergic to azithromycin and or hydroxychloroquine
- Veteran receiving QT prolonging drugs from non-VA pharmacy
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04363203
Start Date
April 30 2020
End Date
August 1 2021
Last Update
June 22 2020
Active Locations (1)
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1
San Francisco VA
San Francisco, California, United States, 94121