search
Back to results

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

Primary Purpose

SARS-CoV-2, COVID-19

Status
Suspended
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Azithromycin
Placebo oral tablet
Sponsored by
Salomeh Keyhani MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV-2

Eligibility Criteria

216 Months - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • San Francisco VA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Hydroxychloroquine

Azithromycin

Placebo

Arm 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

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

The pills packs for the 3 arms are identical.

Outcomes

Primary Outcome Measures

Days to resolution of cough, fever and shortness of breath

Secondary Outcome Measures

Days to resolution of all COVID-19 symptoms
All cause hospitalization
All cause mortality
COVID-19 specific mortality
COVID-19 specific hospitalization

Full Information

First Posted
April 23, 2020
Last Updated
June 18, 2020
Sponsor
Salomeh Keyhani MD
Collaborators
San Francisco VA Health Care System
search

1. Study Identification

Unique Protocol Identification Number
NCT04363203
Brief Title
VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)
Acronym
VA-REACH
Official Title
VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Suspended
Why Stopped
concerns related to study drug
Study Start Date
April 30, 2020 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Salomeh Keyhani MD
Collaborators
San Francisco VA Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydroxychloroquine
Arm Type
Active Comparator
Arm 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
Arm Title
Azithromycin
Arm Type
Active Comparator
Arm Description
Azithromycin: 2x250mg by mouth (PO) in the AM followed by 250mg PO every day on days 2-5
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The pills packs for the 3 arms are identical.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
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
Intervention Name(s)
Azithromycin
Intervention Description
Azithromycin: 2x250mg by mouth (PO) in the AM on Day 1, followed by 250mg PO every day on Days 2-5.
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Placebo in pill packs identical to study drugs
Primary Outcome Measure Information:
Title
Days to resolution of cough, fever and shortness of breath
Time Frame
30-days
Secondary Outcome Measure Information:
Title
Days to resolution of all COVID-19 symptoms
Time Frame
30-days
Title
All cause hospitalization
Time Frame
30-days
Title
All cause mortality
Time Frame
30-days
Title
COVID-19 specific mortality
Time Frame
30-days
Title
COVID-19 specific hospitalization
Time Frame
30-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
216 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salomeh Keyhani, MD MPH
Organizational Affiliation
San Francisco VA/University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco VA
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34011199
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs