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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2021

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 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.

Interventions

  • Drug: 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.
  • Drug: Azithromycin
    • Azithromycin: 2x250mg by mouth (PO) in the AM on Day 1, followed by 250mg PO every day on Days 2-5.
  • Drug: Placebo oral tablet
    • Placebo in pill packs identical to study drugs

Arms, Groups and Cohorts

  • Active Comparator: 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
  • Active Comparator: Azithromycin
    • Azithromycin: 2x250mg by mouth (PO) in the AM followed by 250mg PO every day on days 2-5
  • Placebo Comparator: Placebo
    • The pills packs for the 3 arms are identical.

Clinical Trial Outcome Measures

Primary Measures

  • Days to resolution of cough, fever and shortness of breath
    • Time Frame: 30-days

Secondary Measures

  • Days to resolution of all COVID-19 symptoms
    • Time Frame: 30-days
  • All cause hospitalization
    • Time Frame: 30-days
  • All cause mortality
    • Time Frame: 30-days
  • COVID-19 specific mortality
    • Time Frame: 30-days
  • COVID-19 specific hospitalization
    • Time Frame: 30-days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 216 Months

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Salomeh Keyhani MD
  • Collaborator
    • San Francisco VA Health Care System
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Salomeh Keyhani MD, Professor of Medicine, University of California San Francisco – San Francisco VA Health Care System
  • Overall Official(s)
    • Salomeh Keyhani, MD MPH, Principal Investigator, San Francisco VA/University of California, San Francisco

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