Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19
Purpose
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.
Condition
- COVID-19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Hydroxychloroquine |
|
|
Active Comparator Azithromycin |
|
Recruiting Locations
More Details
- NCT ID
- NCT04329832
- Status
- Completed
- Sponsor
- Intermountain Health Care, Inc.