Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19

Study Overview
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Brief Summary
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This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating outpatients with suspected or confirmed COVID-19.

Official Title
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Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT): A Prospective Pragmatic Trial

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Hydroxychloroquine
* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult, Age>44 years, competent to provide consent Confirmed COVID-19, via a positive nucleic acid assay for COVID-19 within the last 7 days Exclusion Criteria: Participants already prescribed chloroquine, hydroxychloroquine, or azithromycin Allergy to hydroxychloroquine or azithromycin History of bone marrow transplant Known G6PD (Glucose-6-Phosphate Dehydrogenase Deficiency) deficiency Chronic hemodialysis, peritoneal dialysis, continuous renal replacement therapy or Glomerular Filtration Rate < 20ml/min/1.73m2 Liver disease (e.g. Child Pugh score ≥ B or AST (Aspartate Transaminase)>2 times upper limit) Psoriasis Porphyria Known cardiac conduction delay (QTc > 500mSec) or taking any prescription medications known to prolong QT interval Concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone Prisoner Weight < 35kg Inability to follow-up - no cell phone or no address or not Spanish or English speaking Receipt of any experimental treatment for SARS-CoV-2 (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation No symptoms attributable to COVID-19 Pregnant or nursing

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxychloroquine<br> | Drug: Hydroxychloroquine<br>* Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400mg po BID x 1 day, then 200mg po BID x 4 days (dose reductions for weight < 45kg). The drug dose (2.4 gm over 5 days) chosen falls at the lower end of doses proposed in various international trials, but it has proven in vitro efficacy, with a ratio of lung tissue trough concentrations to the EC50 (effective concentration to suppress 50% of viral activity) of >20.<br>|
| Active Comparator: Azithromycin<br> | Drug: Azithromycin<br>* Patients in the azithromycin arm will receive azithromycin 500mg PO on day 1 plus 250mg PO daily on days 2-5.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization within 14 days of enrollment | Admitted to a hospital (not merely kept for emergency room observation) | From enrollment to 14 days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of COVID-19-attributable symptoms |  | From enrollment to 14 days after enrollment | 
| Hospital-free days at 28 days | Hospital-free days at 28 days (number of days patient not in hospital); calculated as worst-rank ordinal with mortality by day 28 assigned the worst score | Admission (day 1) to 28 days after admission (day 28) | 
| Ventilator-free days at 28 days | Ventilator-free days at 28 days (number of days patient not on a ventilator); calculated as worst-rank ordinal with mortality by day 28 assigned the worst score | Admission (day 1) to 28 days after admission (day 28) | 
| ICU-free days at 28 days | ICU-free days at 28 days, calculated as worst-rank ordinal with mortality by day 28 assigned the worst score | Admission (day 1) to 28 days after admission (day 28) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-Co-V-2, Hydroxychloroquine, Azithromycin