This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating hospitalized patients with suspected or confirmed COVID-19.
Drug: Hydroxychloroquine
Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate)<50ml/min). For patients < 45kg, doses will be halved. For patients with GFR<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.
Drug: Azithromycin
Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.
Inclusion Criteria:
- Adult (age ≥ 18 years)
- Confirmed OR suspected COVID-19,
- Confirmed: Positive assay for COVID-19 within the last 10 days
- Suspected: Pending assay for COVID-19 WITH high clinical suspicion
- Scheduled for admission or already admitted to an inpatient bed
Exclusion Criteria:
- Allergy to hydroxychloroquine or azithromycin
- History of bone marrow transplant
- Known G6PD deficiency
- Chronic hemodialysis or Glomerular Filtration Rate < 20ml/min
- Psoriasis
- Porphyria
- Concomitant use of digitalis, flecainide, amiodarone, procainamide, propafenone,
cimetidine, dofetilide, phenobarbital, phenytoin, or sotalol
- Known history of long QT syndrome
- Current known QTc>500 msec
- Pregnant or nursing
- Prisoner
- Weight < 35kg
- Seizure disorder
- Severe liver disease
- Outpatient use of hydroxychloroquine for treatment of a disease other than COVID-19 OR
has received more than 2 days of hydroxychloroquine or azithromycin for suspected or
confirmed COVID-19
- Patient has recovered from COVID-19 and/or is being discharged from the hospital on
day of enrollment.
- Treating physician refuses to allow patient participation in the study
- Unable to obtain informed consent
- Prior enrollment in this study
Intermountain Medical Center
Murray, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Samuel M Brown, MD MS, Principal Investigator
Intermountain Health Care, Inc.