Hydroxychloroquine as Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)

• Status: Recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This a double-blind, randomized, placebo-controlled clinical trial to determine if primary prophylaxis with hydroxychloroquine in healthcare workers reduces symptomatic COVID-19 infection. Healthcare workers will be randomized at a 1:1 allocation between intervention and placebo arms and followed for 12 weeks. This study will enroll up to 1,700 participates in Lafayette, Louisiana. The primary outcome will number of symptomatic COVID-19 infections. Secondary endpoints included number of days healthcare workers are absent from work and rate of severe infection.

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

Details

• Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Collaborators: Lafayette General Health; Lafayette General Medical Center; University of Louisiana at Lafayette; University of Louisiana Lafayette
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

1. Age ≥ 18 years

2. Healthcare or Hospital Worker who has direct patient contact

3. Willing to participate in the research.

4. Able to understand and sign the informed consent form

Exclusion Criteria:

1. Age < 18 years

2. History of ventricular arrhythmia or use of Class IA, IC and III anti-arrhythmics

3. Known prolonged QTc interval

4. History of retinal disease

5. Kidney failure with GFR <10%

6. Chronic hepatic disease w/ Child-Pugh class B or C

7. Hypersensitivity to chloroquine or hydroxychloroquine

8. Currently taking chloroquine or hydroxychloroquine

9. Unwilling to participate

10. Unable to understand and/or sign the informed consent form.