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

NCT04363450 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1700

Last updated 2020-09-02

No results posted yet for this study

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.

Conditions

  • COVID-19
  • Corona Virus Infection
  • Wuhan Coronavirus
  • Prophylaxis
  • Healthcare Worker
  • Sars-CoV2
  • Hydroxychloroquine

Interventions

DRUG

Hydroxychloroquine

Hydroxychloroquine loading 400mg (2 capsules) twice 12 hours apart followed by 200mg (1 capsule) twice weekly

DRUG

Placebo

Loading dose of two placebo capsules twice 12 hours apart followed by 1 capsule twice weekly

Sponsors & Collaborators

  • Lafayette General Health

    collaborator OTHER

  • University of Louisiana at Lafayette

    collaborator OTHER

  • Louisiana State University Health Sciences Center in New Orleans

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-27
Primary Completion
2021-03-31
Completion
2021-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04363450 on ClinicalTrials.gov