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.
Drug: Hydroxychloroquine
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.
Drug: Azithromycin
Patients in the azithromycin arm will receive azithromycin 500mg PO on day 1 plus 250mg PO daily on days 2-5.
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
Intermountain Medical Center
Murray, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Valerie T Aston, MBA
8015074606
Valerie.Aston@imail.org
David P Tomer, MS
801-507-4694
David.Tomer@imail.org
Brandon Webb, MD, Principal Investigator
Intermountain Health Care, Inc.