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

Louisiana State University

Status and phase: Unknown; Phase 3

Conditions: Sars-CoV2; COVID-19; Hydroxychloroquine; Healthcare Worker; Corona Virus Infection; Prophylaxis; Wuhan Coronavirus

Treatments: Drug: Hydroxychloroquine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04363450

LSU NO HSC IRB 20-050

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,700 participants in 2 patient groups, including a placebo group

Hydroxychloroquine

Experimental group

Description:

Hydroxychloroquine loading dose will be given as 400mg for two doses 12 hours apart. This will then be followed by maintenance dosing of 200mg twice weekly for the remainder of the trial.

Treatment:

Drug: Hydroxychloroquine

Placebo

Placebo Comparator group

Description:

An identical placebo will be administered on an identical dosing interval and frequency.

Treatment:

Drug: Placebo