Status:
COMPLETED
Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine
Lead Sponsor:
Adrian Hernandez
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to COVID-19. Eligible participants will be randomly assigned (1:1) to either treat...
Detailed Description
This is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to COVID-19. Eligible participants will be randomly assigned (1:1) to either treat...
Eligibility Criteria
Inclusion
- Inclusion:
- Completed Informed Consent
- Age ≥ 18 years old
- Currently working in any environment in which there is a risk of exposure to patients with COVID-19 infections ("healthcare worker")
- Exclusion Criteria:
- Prior diagnosis of COVID-19 infection
- Participation in another COVID-19 prophylaxis trial within 30 days of consent
- Respiratory illness with new-onset fever (Temperature \> 100°F) or ongoing cough or dyspnea within 14 days
- Known allergy to HCQ or chloroquine
- Congenital prolonged QT syndrome
- Current or planned use of QT prolonging drugs (e.g. procainamide, disopyramide, mexiletine, flecainide, propafenone, amiodarone, sotalol, cimetidine, dronedarone, dofetilide, levofloxacin, ciprofloxacin, moxifloxacin) and other contraindicated medications
- End stage renal disease
- Pre-existing retinopathy
- Current or planned use of Hydroxychloroquine (study drug) for any indication
- Current or planned use of the following for treatment or prevention of COVID-19 infection:
- Chloroquine
- Azithromycin
- Known cirrhosis or severe liver disease
- History of severe skin reactions such as Steven-Johnson syndrome, toxic epidermal necrolysis
- History of psoriasis or porphyria
- Ventricular arrhythmias requiring medical treatment
- Severe coronary artery disease or heart failure/cardiomyopathy with ongoing symptoms
- Current or planned use of use of anti-seizure drugs
- History of Glucose-6-phosphate dehydrogenase deficiency
Exclusion
Key Trial Info
Start Date :
April 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2021
Estimated Enrollment :
1360 Patients enrolled
Trial Details
Trial ID
NCT04334148
Start Date
April 22 2020
End Date
January 9 2021
Last Update
October 12 2021
Active Locations (34)
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1
Children's Hospital Colorado/University of Colorado Denver
Aurora, Colorado, United States, 80045
2
University of Florida
Gainesville, Florida, United States, 32610
3
University of Florida Jacksonville
Jacksonville, Florida, United States, 32206
4
University of Florida Health Central Florida
Leesburg, Florida, United States, 34748