Official Title
Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19 (HAHPS): A Prospective Pragmatic Trial
Brief Summary

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.

Completed
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.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

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.

University of Utah
NCT Number
Keywords
SARS-CoV-2
hydroxychloroquine
azithromycin
MeSH Terms
COVID-19
Azithromycin
Hydroxychloroquine