VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL) (VA-REACH)
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ClinicalTrials.gov Identifier: NCT04363203 |
Recruitment Status :
Suspended
(concerns related to study drug)
First Posted : April 27, 2020
Last Update Posted : June 22, 2020
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Condition or disease | Intervention/treatment | Phase |
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SARS-CoV-2 COVID-19 | Drug: Hydroxychloroquine Drug: Azithromycin Drug: Placebo oral tablet | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Intervention 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: | Quadruple (Participant, Care Provider, Investigator, Outcomes 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. |
Primary Purpose: | Treatment |
Official Title: | VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL) |
Actual Study Start Date : | April 30, 2020 |
Estimated Primary Completion Date : | March 2021 |
Estimated Study Completion Date : | August 2021 |

Arm | Intervention/treatment |
---|---|
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
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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. |
Active Comparator: Azithromycin
Azithromycin: 2x250mg by mouth (PO) in the AM followed by 250mg PO every day on days 2-5
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Drug: Azithromycin
Azithromycin: 2x250mg by mouth (PO) in the AM on Day 1, followed by 250mg PO every day on Days 2-5. |
Placebo Comparator: Placebo
The pills packs for the 3 arms are identical.
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Drug: Placebo oral tablet
Placebo in pill packs identical to study drugs |
- Days to resolution of cough, fever and shortness of breath [ Time Frame: 30-days ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 216 Months and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04363203
United States, California | |
San Francisco VA | |
San Francisco, California, United States, 94121 |
Principal Investigator: | Salomeh Keyhani, MD MPH | San Francisco VA/University of California, San Francisco |
Responsible Party: | Salomeh Keyhani MD, Professor of Medicine, University of California San Francisco, San Francisco VA Health Care System |
ClinicalTrials.gov Identifier: | NCT04363203 |
Other Study ID Numbers: |
20-30517 |
First Posted: | April 27, 2020 Key Record Dates |
Last Update Posted: | June 22, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases |
Respiratory Tract Diseases Azithromycin Hydroxychloroquine Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |