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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
Sponsor:
Collaborator:
San Francisco VA Health Care System
Information provided by (Responsible Party):
Salomeh Keyhani MD, San Francisco VA Health Care System

Study Description
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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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin Drug: Placebo oral tablet Phase 3

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.
Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
 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
 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.
 Drug: Placebo oral tablet
Placebo in pill packs identical to study drugs


Outcome Measures
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Primary Outcome Measures :
  1. Days to resolution of cough, fever and shortness of breath [ Time Frame: 30-days ]

Secondary Outcome Measures :
  1. Days to resolution of all COVID-19 symptoms [ Time Frame: 30-days ]
  2. All cause hospitalization [ Time Frame: 30-days ]
  3. All cause mortality [ Time Frame: 30-days ]
  4. COVID-19 specific mortality [ Time Frame: 30-days ]
  5. COVID-19 specific hospitalization [ Time Frame: 30-days ]

Eligibility Criteria
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Ages Eligible for Study:   216 Months and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
San Francisco VA
San Francisco, California, United States, 94121
Sponsors and Collaborators
Salomeh Keyhani MD
San Francisco VA Health Care System
Investigators
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Principal Investigator: Salomeh Keyhani, MD MPH San Francisco VA/University of California, San Francisco
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
 Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents