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 treatment group (HCQ) or placebo in a double-blind fashion. Course of treatment is 30 days.
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 treatment group (HCQ) or placebo in a double-blind fashion. After enrollment,
baseline assessments will include nasopharyngeal swab for COVID-19 and a blood sample to
detect seroconversion to COVID-19. For convenience, follow-up will be performed weekly
through a direct to participant portal. A call center will provide support for any missed
visits. Follow-up includes screening for any COVID-19 clinical infections, other respiratory
infections, clinical events, adverse events, and Quality of Life (QoL) assessments. Course of
treatment is 30 days. Participants are followed via survey weekly. At the end of treatment
participants will return for repeat nasopharyngeal swab for COVID-19 and a blood sample to
detect seroconversion to COVID-19. There will be one last contact at 8 weeks (2 months) from
baseline.
Drug: Hydroxychloroquine
oral self administered tablet
Other Name: Plaquenil
Drug: Placebo oral tablet
oral self administered tablet
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
Children's Hospital Colorado/University of Colorado Denver
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of Florida Jacksonville
Jacksonville, Florida, United States
University of Florida Health Central Florida
Leesburg, Florida, United States
University of Miami Florida
Miami, Florida, United States
Advent Health
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Northwestern Medicine
Chicago, Illinois, United States
Rush University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Johns Hopkins
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Allina Health
Minneapolis, Minnesota, United States
Mayo Clinic Hospital Rochester
Rochester, Minnesota, United States
University of Missouri-Columbia
Columbia, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Hospital for Special Surgery
New York, New York, United States
Columbia University, Irving Medical Center
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor Scott & White Medical Center-Temple
Temple, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Marshfield Clinic Health System
Marshfield, Wisconsin, United States
Adrian Hernandez, MD, Principal Investigator
Duke University