Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19

• Status: Active, not 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 hospitalized patients with suspected or confirmed COVID-19.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

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