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Purpose

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

Eligibility

Eligible Ages
Over 216 Months
Eligible Genders
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

Study Design

Phase
Phase 3
Study Type
Interventional
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.
Primary Purpose
Treatment
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.

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04363203
Status
Suspended
Sponsor
Salomeh Keyhani MD

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.