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

NCT04363203 | Suspended Phase 3 DMC FDA Drug

• 1 other identifier: 20-30517
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS-CoV-2; COVID-19

Outcome Measures

Primary Outcomes (1)

• Days to resolution of cough, fever and shortness of breath

  30-days

Secondary Outcomes (5)

• Days to resolution of all COVID-19 symptoms

  30-days

• All cause hospitalization

  30-days

• All cause mortality

  30-days

• COVID-19 specific mortality

  30-days

• COVID-19 specific hospitalization

  30-days

Study Arms (3)

Hydroxychloroquine

ACTIVE COMPARATOR

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

Drug: Hydroxychloroquine

Azithromycin

ACTIVE COMPARATOR

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

Drug: Azithromycin

Placebo

PLACEBO COMPARATOR

The pills packs for the 3 arms are identical.

Drug: Placebo oral tablet

Interventions

Hydroxychloroquine 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.

Hydroxychloroquine

Azithromycin DRUG

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

Azithromycin

Placebo oral tablet DRUG

Placebo in pill packs identical to study drugs

Placebo

Eligibility Criteria

• Age: 216 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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
• any female who is breastfeeding or pregnant or planning to become pregnant.

Sponsors & Collaborators

• Salomeh Keyhani MD: lead
• San Francisco VA Health Care System: collaborator

Study Sites (1)

San Francisco VA

San Francisco, California, 94121, United States

Location

Related Publications (1)

• Keyhani S, Kelly JD, Bent S, Boscardin WJ, Shlipak MG, Leonard S, Abraham A, Lum E, Lau N, Austin C, Oldenburg CE, Zillich A, Lopez L, Zhang Y, Lietman T, Bravata DM. A telehealth-based randomized controlled trial: A model for outpatient trials of off-label medications during the COVID-19 pandemic. Clin Trials. 2021 Aug;18(4):514-517. doi: 10.1177/17407745211011577. Epub 2021 May 20.

  PMID: 34011199 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine; Azithromycin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Salomeh Keyhani, MD MPH

  San Francisco VA/University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine, University of California San Francisco

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: April 30, 2020
• Primary Completion: March 1, 2021
• Study Completion: August 1, 2021
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)