Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Hydroxychloroquine; Azithromycin
Intervention description: 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.; 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.
Intervention MeSH terms: Azithromycin; Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; Hydroxychloroquine; Azithromycin

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.
    

Eligibility 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