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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intermountain Health Care, Inc.
• Collaborators: University of Utah; Utah Department of Health
• Treatments: Azithromycin; Hydroxychloroquine

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