VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)

• Status: Suspended
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Salomeh Keyhani MD
• Collaborator: San Francisco VA Health Care System
• Treatments: Azithromycin; Hydroxychloroquine

Criteria

Inclusion Criteria:

• 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 Criteria:

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