Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine

• Status: Completed
• Trial end date: 2021-01-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Adrian Hernandez; Duke University
• Collaborator: Patient-Centered Outcomes Research Institute
• Treatments: Hydroxychloroquine

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