Status:
COMPLETED
University of Utah COVID-19 Hydrochloroquine Trial
Lead Sponsor:
University of Utah
Conditions:
Coronavirus Infection
Coronavirus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A novel coronavirus, SARS-CoV-2, is responsible for a rapidly spreading pandemic that has reached 160 countries, infecting over 500,000 individuals and killing more than 24,000 people. SARS-CoV-2 caus...
Detailed Description
Background COVID-19 is pandemic with high mortality among hospitalized patients despite a benign course in the large majority of patients infected. Limited data are available from small outpatient stu...
Eligibility Criteria
Inclusion
- Patient age ≥18 years, competent to provide consent
- Within 48 hours of positive nucleic acid test for SARS-CoV-2
Exclusion
- Patient already prescribed chloroquine or hydroxychloroquine
- Allergy to hydroxychloroquine
- History of bone marrow or solid organ transplant
- Known G6PD deficiency
- Chronic hemodialysis, peritoneal dialysis, continuous renal replacement therapy or Glomerular Filtration Rate \< 20ml/min/1.73m2
- Known liver disease (e.g. Child Pugh score ≥ B or AST\>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
- Seizure disorder
- 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
- Patient or another member of patient's household has been already enrolled in this study.
Key Trial Info
Start Date :
April 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2021
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT04342169
Start Date
April 4 2020
End Date
November 15 2021
Last Update
February 15 2023
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84108