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.
The study is a double blind placebo controlled at two hospitals in Lafayette, Louisiana
aiming to enroll 1700 participants with a 1:1 randomization. The HCQ dose in 400mg twice on
day 1, then 200mg twice weekly. The primary outcome variable is development of symptomatic
COVID-19 infection. The secondary objectives are number of days absent from work due to
symptomatic COVID-19 infection and rate of severe disease due to COVID-19 (hypoxia in setting
of >50% lung involvement on chest imaging, respiratory failure, shock or end-organ damage).
The study will enroll participants for four weeks with and plan to treat with
hydroxychloroquine versus placebo for a total of 12 weeks.
Drug: Hydroxychloroquine
Hydroxychloroquine loading 400mg (2 capsules) twice 12 hours apart followed by 200mg (1 capsule) twice weekly
Other Name: HCQ PreP
Drug: Placebo
Loading dose of two placebo capsules twice 12 hours apart followed by 1 capsule twice weekly
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.
Lafayette General Medical Center
Lafayette, Louisiana, United States
University Hospital and Clinics
Lafayette, Louisiana, United States
Ann D. Chauffe, DO, MPH
337-261-6161
achauf@lsuhsc.edu
Rebecca B. Lee, DO, MS
337-261-6000
rlee10@lsuhsc.edu