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

ArmDescriptionAssigned Intervention
Experimental
Hydroxychloroquine
  • Drug: Hydroxychloroquine
    Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate)<50ml/min). For patients < 45kg, doses will be halved. For patients with GFR<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.
Active Comparator
Azithromycin
  • Drug: Azithromycin
    Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.

Recruiting Locations

More Details

NCT ID
NCT04329832
Status
Completed
Sponsor
Intermountain Health Care, Inc.