Hydroxychloroquine as Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Corona Virus Infection
- COVID-19
- Healthcare Worker
- Hydroxychloroquine
- Prophylaxis
- SARS COV2
- Wuhan Coronavirus
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, placebo-controlled, double-blind study with 1:1 randomization of hydroxychloroquine to placeboMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Participants will be randomized to the investigational drug (hydroxychloroquine) or placebo. Both will have identical appearance and will be taken at the same dosing interval. The administration of the drug and assessment will be blinded. After final analysis, study arms will be unmasked.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 secon...
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.
Tracking Information
- NCT #
- NCT04363450
- Collaborators
- Lafayette General Health
- University of Louisiana at Lafayette
- Investigators
- Not Provided
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