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

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Hydroxychloroquine	Hydroxychloroquine	-
Azithromycin	Azithromycin	-

Primary Outcome Measures

Name	Time	Method
COVID Ordinal Outcomes Scale at 14 Days	Assessed once on day 14 after enrollment (enrollment is day 0)	Improvement of clinical condition of the patient defined by the COVID-19 WHO ordinal Outcomes score. This scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".

Secondary Outcome Measures

Name	Time	Method
Hospital-free Days at 28 Days	Admission (day 1) to 28 days after admission (day 28)	Calculated as number of days patient not in hospital
Time to a 1-point Decrease in the WHO Ordinal Recovery Score	Admission (day 1) to 14 days after admission (day 14)	Time to 1-point decrease in the WHO ordinal recovery score is defined as the number of days until the ordinal outcome score drops by 1 relative to baseline on the 8-point WHO COVID Ordinal Outcomes scale, which reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".
Ventilator-free Days at 28 Days (Number of Days Patient Not on a Ventilator)	Admission (day 1) to 28 days after admission (day 28)	Calculated as number of days that patient is not on a ventilator up to day 28 days after admission
ICU-free Days at 28 Days	Admission (day 1) to 28 days after admission (day 28)	Calculated as number of days patient not in an ICU