Clinical trial NCT04363450: Hydroxychloroquine as Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)
Official title: Hydroxychloroquine as Primary Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19
Corona Virus Infection
Wuhan Coronavirus
Prophylaxis
Healthcare Worker
Sars-CoV2
Hydroxychloroquine
Keywords: COVID-19
COVID-19 Prophylaxis
Healthcare Workers
SARS-COV-2
Hydroxychloroquine
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
Collaborators: name: Lafayette General Health
name: University of Louisiana at Lafayette
First posted: 2020-04-27
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled, double-blind study with 1:1 randomization of hydroxychloroquine to placebo
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of symptomatic COVID-19 infection in healthcare workers
timeFrame: 12 weeks
Secondary outcomes:
measure: Absenteeism from work due to COVID-19
timeFrame: 12 weeks
measure: Severity of COVID-19 infection
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lafayette
country: United States
facility: Lafayette General Medical Center
state: Louisiana
city: Lafayette
country: United States
facility: University Hospital and Clinics
state: Louisiana
Study officials:
References: