COVID-19, SARS-CoV-2
Conditions
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.
Interventions
DRUGHydroxychloroquine
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.
DRUGAzithromycin
Azithromycin: 2x250mg by mouth (PO) in the AM on Day 1, followed by 250mg PO every day on Days 2-5.
DRUGPlacebo oral tablet
Placebo in pill packs identical to study drugs
Sponsors
San Francisco VA Health Care System
Salomeh Keyhani MD
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
ALL
Age
216 Months to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days to resolution of cough, fever and shortness of breath | 30-days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed