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

Primary Purpose

COVID-19, Corona Virus Infection, Wuhan Coronavirus

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Placebo
Sponsored by
Louisiana State University Health Sciences Center in New Orleans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, COVID-19 Prophylaxis, Healthcare Workers, SARS-COV-2, Hydroxychloroquine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Lafayette General Medical CenterRecruiting
  • University Hospital and ClinicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydroxychloroquine

Placebo

Arm Description

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.

An identical placebo will be administered on an identical dosing interval and frequency.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Absenteeism from work due to COVID-19
Number of days healthcare workers are absent from work due to symptomatic COVID-19 infection
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)

Full Information

First Posted
April 23, 2020
Last Updated
August 31, 2020
Sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborators
Lafayette General Health, University of Louisiana at Lafayette
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1. Study Identification

Unique Protocol Identification Number
NCT04363450
Brief Title
Hydroxychloroquine as Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)
Acronym
HCQPreP
Official Title
Hydroxychloroquine as Primary Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 27, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborators
Lafayette General Health, University of Louisiana at Lafayette

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, placebo-controlled, double-blind study with 1:1 randomization of hydroxychloroquine to placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants will be randomized to the investigational drug (hydroxychloroquine) or placebo. Both will have identical appearance and will be taken at the same dosing interval. The administration of the drug and assessment will be blinded. After final analysis, study arms will be unmasked.
Allocation
Randomized
Enrollment
1700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydroxychloroquine
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
An identical placebo will be administered on an identical dosing interval and frequency.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
HCQ PreP
Intervention Description
Hydroxychloroquine loading 400mg (2 capsules) twice 12 hours apart followed by 200mg (1 capsule) twice weekly
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Loading dose of two placebo capsules twice 12 hours apart followed by 1 capsule twice weekly
Primary Outcome Measure Information:
Title
Incidence of symptomatic COVID-19 infection in healthcare workers
Description
Number of participants who develop symptoms of COVID-19 in the setting of a positive COVID-19 assay
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Absenteeism from work due to COVID-19
Description
Number of days healthcare workers are absent from work due to symptomatic COVID-19 infection
Time Frame
12 weeks
Title
Severity of COVID-19 infection
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Healthcare or Hospital Worker who has direct patient contact Willing to participate in the research. Able to understand and sign the informed consent form Exclusion Criteria: Age < 18 years History of ventricular arrhythmia or use of Class IA, IC and III anti-arrhythmics Known prolonged QTc interval History of retinal disease Kidney failure with GFR <10% Chronic hepatic disease w/ Child-Pugh class B or C Hypersensitivity to chloroquine or hydroxychloroquine Currently taking chloroquine or hydroxychloroquine Unwilling to participate Unable to understand and/or sign the informed consent form.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann D. Chauffe, DO, MPH
Phone
337-261-6161
Email
achauf@lsuhsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca B. Lee, DO, MS
Phone
337-261-6000
Email
rlee10@lsuhsc.edu
Facility Information:
Facility Name
Lafayette General Medical Center
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann D Chauffe, DO, MPH
Phone
337-261-6000
Email
achauf@lsuhsc.edu
First Name & Middle Initial & Last Name & Degree
Rebecca B Lee, DO, MS
First Name & Middle Initial & Last Name & Degree
Nicholas Sells, MD
First Name & Middle Initial & Last Name & Degree
James B Falterman, MD
First Name & Middle Initial & Last Name & Degree
Carl Sabottke, MD
First Name & Middle Initial & Last Name & Degree
Daniel Stouts, MD
First Name & Middle Initial & Last Name & Degree
Ann D Chauffe, DO, MPH
Facility Name
University Hospital and Clinics
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann D Chauffe, DO, MPH
Phone
337-261-6000
Email
achauf@lsuhsc.edu
First Name & Middle Initial & Last Name & Degree
Ann D Chauffe, DO, MPH
First Name & Middle Initial & Last Name & Degree
Rebecca B Lee, DO, MS
First Name & Middle Initial & Last Name & Degree
Nicholas Sells, MD
First Name & Middle Initial & Last Name & Degree
James B Falterman, MD
First Name & Middle Initial & Last Name & Degree
Carl Sabottke, MD
First Name & Middle Initial & Last Name & Degree
Daniel Stout, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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