Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04334148

Run by

Adrian Hernandez

People needed

1360

Starts

2020-04-22

Expected to finish

2021-01-09

Last updated by the study team

2021-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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