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

Paused · Phase 3 · Has a placebo group

Conditions studied: SARS-CoV-2, COVID-19

In brief

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.

Key facts

Study ID

NCT04363203

Run by

Salomeh Keyhani MD

People needed

300

Starts

2020-04-30

Expected to finish

2021-08-01

Last updated by the study team

2020-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• San Francisco VA — San Francisco, California, United States

Full record on ClinicalTrials.gov

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