Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19
- Registration Number
- NCT04334382
- Lead Sponsor
- Intermountain Health Care, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1550
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Azithromycin Azithromycin - Hydroxychloroquine Hydroxychloroquine -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Duration of COVID-19-attributable symptoms From enrollment to 14 days after enrollment 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
Trial Locations
- Locations (2)
Intermountain Medical Center
🇺🇸Murray, Utah, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States