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

Phase 3

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

• Registration Number: NCT04363450
• Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans

Brief 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.

Study Timeline

• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-23
• Study Start: 2020-04-27
• Study First Posted: 2020-04-27
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02
• Primary Completion: 2021-03-31
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1700

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	An identical placebo will be administered on an identical dosing interval and frequency.
Hydroxychloroquine	Hydroxychloroquine	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.

Primary Outcome Measures

Name	Time	Method
Incidence of symptomatic COVID-19 infection in healthcare workers	12 weeks	Number of participants who develop symptoms of COVID-19 in the setting of a positive COVID-19 assay

Secondary Outcome Measures

Name	Time	Method
Absenteeism from work due to COVID-19	12 weeks	Number of days healthcare workers are absent from work due to symptomatic COVID-19 infection
Severity of COVID-19 infection	12 weeks	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)

Trial Locations

Locations (2)

Lafayette General Medical Center; 🇺🇸 Lafayette, Louisiana, United States

University Hospital and Clinics; 🇺🇸 Lafayette, Louisiana, United States