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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Hydroxychloroquine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Healthcare or Hospital Worker who has direct patient contact Willing to participate in the research. Able to understand and sign the informed consent form Exclusion Criteria: Age < 18 years History of ventricular arrhythmia or use of Class IA, IC and III anti-arrhythmics Known prolonged QTc interval History of retinal disease Kidney failure with GFR <10% Chronic hepatic disease w/ Child-Pugh class B or C Hypersensitivity to chloroquine or hydroxychloroquine Currently taking chloroquine or hydroxychloroquine Unwilling to participate Unable to understand and/or sign the informed consent form.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, placebo-controlled, double-blind study with 1:1 randomization of hydroxychloroquine to placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxychloroquine<br>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. | Drug: Hydroxychloroquine<br>* Hydroxychloroquine loading 400mg (2 capsules) twice 12 hours apart followed by 200mg (1 capsule) twice weekly<br>* Other names: HCQ PreP;|
| Placebo Comparator: Placebo<br>An identical placebo will be administered on an identical dosing interval and frequency. | Drug: Placebo<br>* Loading dose of two placebo capsules twice 12 hours apart followed by 1 capsule twice weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic COVID-19 infection in healthcare workers | Number of participants who develop symptoms of COVID-19 in the setting of a positive COVID-19 assay | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absenteeism from work due to COVID-19 | Number of days healthcare workers are absent from work due to symptomatic COVID-19 infection | 12 weeks | 
| Severity of COVID-19 infection | Rate of severe COVID-19 infection in healthcare works (hypoxia in setting of chest imaging >50% lung involvement, respiratory failure, end organ damage or shock) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, COVID-19 Prophylaxis, Healthcare Workers, SARS-COV-2, Hydroxychloroquine