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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2021-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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SARS-CoV-2 COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Hydroxychloroquine

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

Group Type ACTIVE_COMPARATOR

Hydroxychloroquine

Intervention Type DRUG

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.

Azithromycin

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

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

Azithromycin: 2x250mg by mouth (PO) in the AM on Day 1, followed by 250mg PO every day on Days 2-5.

Placebo

The pills packs for the 3 arms are identical.

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Placebo in pill packs identical to study drugs

Interventions

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Hydroxychloroquine

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.

Intervention Type DRUG

Azithromycin

Azithromycin: 2x250mg by mouth (PO) in the AM on Day 1, followed by 250mg PO every day on Days 2-5.

Intervention Type DRUG

Placebo oral tablet

Placebo in pill packs identical to study drugs

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

216 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No