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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,700
Hydroxychloroquine loading 400mg (2 capsules) twice 12 hours apart followed by 200mg (1 capsule) twice weekly
Loading dose of two placebo capsules twice 12 hours apart followed by 1 capsule twice weekly
Lafayette General Medical Center
Lafayette, Louisiana, United States
RECRUITINGUniversity Hospital and Clinics
Lafayette, Louisiana, United States
RECRUITINGIncidence 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
Time frame: 12 weeks
Absenteeism from work due to COVID-19
Number of days healthcare workers are absent from work due to symptomatic COVID-19 infection
Time frame: 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)
Time frame: 12 weeks
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