NCT04363450

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,700 (estimated)
• Sponsor: Louisiana State University Health Sciences Center in New Orleans · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• COVID-19
• Corona Virus Infection
• Wuhan Coronavirus
• Prophylaxis
• Healthcare Worker
• Sars-CoV2
• Hydroxychloroquine

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Hydroxychloroquine loading 400mg (2 capsules) twice 12 hours apart followed by 200mg (1 capsule) twice weekly
DRUG	Placebo	Loading dose of two placebo capsules twice 12 hours apart followed by 1 capsule twice weekly

Timeline

• Start date: 2020-04-27
• Primary completion: 2021-03-31
• Completion: 2021-06-01
• First posted: 2020-04-27
• Last updated: 2020-09-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study