Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT)

Intermountain Health Care, Inc.

Status and phase

Unknown

Phase 3

Conditions

COVID-19

Treatments

Drug: Hydroxychloroquine

Drug: Azithromycin

Study type

Interventional

Funder types

Other

Identifiers

NCT04334382

1051360

Details and patient eligibility

About

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.

Enrollment

1,550 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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