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

COVID-19 Clinical Trial

— HCQPreP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04363450
• Other study ID #: LSU NO HSC IRB 20-050
• Status: Recruiting
• Phase: Phase 3
• Start date: April 27, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: August 2020
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: Ann D. Chauffe, DO, MPH
• Phone: 337-261-6161
• Email: achauf[@]lsuhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1700
• Est. completion date: June 1, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Healthcare Worker
• Hydroxychloroquine
• Prophylaxis
• Sars-CoV2
• Severe Acute Respiratory Syndrome
• Wuhan Coronavirus

Intervention

Drug:
• Hydroxychloroquine
Hydroxychloroquine loading 400mg (2 capsules) twice 12 hours apart followed by 200mg (1 capsule) twice weekly
• Placebo
Loading dose of two placebo capsules twice 12 hours apart followed by 1 capsule twice weekly

Locations

Country	Name	City	State
United States	Lafayette General Medical Center	Lafayette	Louisiana
United States	University Hospital and Clinics	Lafayette	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans	Lafayette General Health, University of Louisiana at Lafayette

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Absenteeism from work due to COVID-19	Number of days healthcare workers are absent from work due to symptomatic COVID-19 infection	12 weeks
Secondary	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