Official Title
Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT): 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 outpatients with suspected or confirmed COVID-19.

Unknown status
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.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 45 Years ~ Maximum: N/A
Countries
United States
Locations

Intermountain Medical Center
Murray, Utah, United States

University of Utah
Salt Lake City, Utah, United States

Contacts

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.

Intermountain Health Care, Inc.
NCT Number
Keywords
SARS-Co-V-2
hydroxychloroquine
azithromycin
MeSH Terms
COVID-19
Azithromycin
Hydroxychloroquine