Official Title
Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial)
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 treatment group (HCQ) or placebo in a double-blind fashion. Course of treatment is 30 days.

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 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.

Completed
COVID-19

Drug: Hydroxychloroquine

oral self administered tablet
Other Name: Plaquenil

Drug: Placebo oral tablet

oral self administered tablet

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

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

Patient-Centered Outcomes Research Institute
NCT Number
Keywords
hydroxychloroquine
Coronavirus Infections
novel coronavirus
Protective agents
prophylaxis
chemoprophylaxis
Severe acute respiratory syndrome
respiratory distress syndrome, adult
Acute Lung Injury
Virus Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Lung Injury
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Chloroquine
Chloroquine Diphosphate
MeSH Terms
Hydroxychloroquine