Status:
UNKNOWN
Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19
Lead Sponsor:
Intermountain Health Care, Inc.
Collaborating Sponsors:
University of Utah
Utah Department of Health
Conditions:
COVID-19
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
1550 Patients enrolled
Trial Details
Trial ID
NCT04334382
Start Date
April 2 2020
End Date
December 31 2021
Last Update
April 9 2020
Active Locations (2)
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1
Intermountain Medical Center
Murray, Utah, United States, 84107
2
University of Utah
Salt Lake City, Utah, United States, 84112