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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
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.
Intermountain Medical Center
Murray, Utah, United States
University of Utah
Salt Lake City, Utah, United States
COVID Ordinal Outcomes Scale at 14 Days
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".
Time frame: Assessed once on day 14 after enrollment (enrollment is day 0)
Hospital-free Days at 28 Days
Calculated as number of days patient not in hospital
Time frame: Admission (day 1) to 28 days after admission (day 28)
Ventilator-free Days at 28 Days (Number of Days Patient Not on a Ventilator)
Calculated as number of days that patient is not on a ventilator up to day 28 days after admission
Time frame: Admission (day 1) to 28 days after admission (day 28)
ICU-free Days at 28 Days
Calculated as number of days patient not in an ICU
Time frame: Admission (day 1) to 28 days after admission (day 28)
Time to a 1-point Decrease in the WHO Ordinal Recovery Score
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".
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Time frame: Admission (day 1) to 14 days after admission (day 14)