A Phase 3 interventional study of Hydroxychloroquine and Placebo in COVID-19, Corona Virus Infection and Wuhan Coronavirus, sponsored by Louisiana State University Health Sciences Center in New Orleans. Status unknown at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-02.
Sponsored by Louisiana State University Health Sciences Center in New Orleans · Phase 3, Interventional, and Prevention
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 1,700 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Louisiana State University Health Sciences Center in New Orleans is the lead sponsor of 70 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Exclusion Criteria:
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
An identical placebo will be administered on an identical dosing interval and frequency.
Drug: Placebo
Hydroxychloroquine loading 400mg (2 capsules) twice 12 hours apart followed by 200mg (1 capsule) twice weekly
Also known as: HCQ PreP
Loading dose of two placebo capsules twice 12 hours apart followed by 1 capsule twice weekly
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Louisiana State University Health Sciences Center in New Orleans