COVID-19
Conditions
Keywords
SARS-Co-V-2, Hydroxychloroquine, Azithromycin
Brief summary
This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating outpatients with suspected or confirmed COVID-19.
Interventions
DRUGHydroxychloroquine
Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400mg po BID x 1 day, then 200mg po BID x 4 days (dose reductions for weight \< 45kg). The drug dose (2.4 gm over 5 days) chosen falls at the lower end of doses proposed in various international trials, but it has proven in vitro efficacy, with a ratio of lung tissue trough concentrations to the EC50 (effective concentration to suppress 50% of viral activity) of \>20.
DRUGAzithromycin
Patients in the azithromycin arm will receive azithromycin 500mg PO on day 1 plus 250mg PO daily on days 2-5.
Sponsors
University of Utah
Utah Department of Health
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult, Age\>44 years, competent to provide consent * Confirmed COVID-19, via a positive nucleic acid assay for COVID-19 within the last 7 days
Exclusion criteria
* Participants already prescribed chloroquine, hydroxychloroquine, or azithromycin * Allergy to hydroxychloroquine or azithromycin * History of bone marrow transplant * Known G6PD (Glucose-6-Phosphate Dehydrogenase Deficiency) deficiency * Chronic hemodialysis, peritoneal dialysis, continuous renal replacement therapy or Glomerular Filtration Rate \< 20ml/min/1.73m2 * Liver disease (e.g. Child Pugh score ≥ B or AST (Aspartate Transaminase)\>2 times upper limit) * Psoriasis * Porphyria * Known cardiac conduction delay (QTc \> 500mSec) or taking any prescription medications known to prolong QT interval * Concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone * Prisoner * Weight \< 35kg * Inability to follow-up - no cell phone or no address or not Spanish or English speaking * Receipt of any experimental treatment for SARS-CoV-2 (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation * No symptoms attributable to COVID-19 * Pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization within 14 days of enrollment | From enrollment to 14 days after enrollment | Admitted to a hospital (not merely kept for emergency room observation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of COVID-19-attributable symptoms | From enrollment to 14 days after enrollment | — |
| Hospital-free days at 28 days | Admission (day 1) to 28 days after admission (day 28) | Hospital-free days at 28 days (number of days patient not in hospital); calculated as worst-rank ordinal with mortality by day 28 assigned the worst score |
| Ventilator-free days at 28 days | Admission (day 1) to 28 days after admission (day 28) | Ventilator-free days at 28 days (number of days patient not on a ventilator); calculated as worst-rank ordinal with mortality by day 28 assigned the worst score |
| ICU-free days at 28 days | Admission (day 1) to 28 days after admission (day 28) | ICU-free days at 28 days, calculated as worst-rank ordinal with mortality by day 28 assigned the worst score |
Countries
United States
Contacts
Primary ContactValerie T Aston, MBA
Backup ContactDavid P Tomer, MS
Outcome results
None listed