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

Salomeh Keyhani MD

Status and phase: Suspended; Phase 3

Conditions: COVID-19; SARS-CoV-2

Treatments: Drug: Placebo oral tablet; Drug: Hydroxychloroquine; Drug: Azithromycin

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04363203

20-30517

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 216+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups, including a placebo group

Hydroxychloroquine

Active Comparator group

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

Treatment:

Drug: Hydroxychloroquine

Azithromycin

Active Comparator group

Description:

Azithromycin: 2x250mg by mouth (PO) in the AM followed by 250mg PO every day on days 2-5

Treatment:

Drug: Azithromycin

Placebo

Placebo Comparator group

Description:

The pills packs for the 3 arms are identical.

Treatment:

Drug: Placebo oral tablet