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

August 31, 2020 updated by: Ann Chauffe, Louisiana State University Health Sciences Center in New Orleans

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1700

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Recruiting
        • Lafayette General Medical Center
        • Contact:
        • Sub-Investigator:
          • Rebecca B Lee, DO, MS
        • Sub-Investigator:
          • Nicholas Sells, MD
        • Sub-Investigator:
          • James B Falterman, MD
        • Sub-Investigator:
          • Carl Sabottke, MD
        • Sub-Investigator:
          • Daniel Stouts, MD
        • Principal Investigator:
          • Ann D Chauffe, DO, MPH
      • Lafayette, Louisiana, United States, 70506
        • Recruiting
        • University Hospital and Clinics
        • Contact:
        • Sub-Investigator:
          • Rebecca B Lee, DO, MS
        • Sub-Investigator:
          • Nicholas Sells, MD
        • Sub-Investigator:
          • James B Falterman, MD
        • Sub-Investigator:
          • Carl Sabottke, MD
        • Principal Investigator:
          • Ann D Chauffe, DO, MPH
        • Sub-Investigator:
          • Daniel Stout, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hydroxychloroquine
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
Hydroxychloroquine loading 400mg (2 capsules) twice 12 hours apart followed by 200mg (1 capsule) twice weekly
Other Names:
  • HCQ PreP
PLACEBO_COMPARATOR: Placebo
An identical placebo will be administered on an identical dosing interval and frequency.
Drug: Placebo
Loading dose of two placebo capsules twice 12 hours apart followed by 1 capsule twice weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of symptomatic COVID-19 infection in healthcare workers
Time Frame: 12 weeks
Number of participants who develop symptoms of COVID-19 in the setting of a positive COVID-19 assay
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absenteeism from work due to COVID-19
Time Frame: 12 weeks
Number of days healthcare workers are absent from work due to symptomatic COVID-19 infection
12 weeks
Severity of COVID-19 infection
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Collaborators

University of Louisiana at Lafayette
Lafayette General Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 27, 2020

Primary Completion (ANTICIPATED)

March 31, 2021

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (ACTUAL)

April 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSU NO HSC IRB 20-050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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