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

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ClinicalTrials.gov Identifier: NCT04363450
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : April 29, 2020
Sponsor:
Collaborators:
Lafayette General Health
University of Louisiana at Lafayette
Information provided by (Responsible Party):
Ann Chauffe, Louisiana State University Health Sciences Center in New Orleans

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.

Condition or disease Intervention/treatment Phase
COVID-19 Corona Virus Infection Wuhan Coronavirus Prophylaxis Healthcare Worker Sars-CoV2 Hydroxychloroquine Drug: Hydroxychloroquine Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, placebo-controlled, double-blind study with 1:1 randomization of hydroxychloroquine to placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Prevention
Official Title: Hydroxychloroquine as Primary Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)
Actual Study Start Date : April 27, 2020
Estimated Primary Completion Date : July 6, 2020
Estimated Study Completion Date : August 3, 2020


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 Name: 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04363450


Contacts
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Contact: Ann D. Chauffe, DO, MPH 337-261-6161 achauf@lsuhsc.edu
Contact: Rebecca B. Lee, DO, MS 337-261-6000 rlee10@lsuhsc.edu

Locations
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United States, Louisiana
Lafayette General Medical Center Recruiting
Lafayette, Louisiana, United States, 70503
Contact: Ann D Chauffe, DO, MPH    337-261-6000    achauf@lsuhsc.edu   
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         
University Hospital and Clinics Recruiting
Lafayette, Louisiana, United States, 70506
Contact: Ann D Chauffe, DO, MPH    337-261-6000    achauf@lsuhsc.edu   
Principal Investigator: Ann D Chauffe, DO, MPH         
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 Stout, MD         
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Lafayette General Health
University of Louisiana at Lafayette
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Responsible Party: Ann Chauffe, DO, MPH, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT04363450    
Other Study ID Numbers: LSU NO HSC IRB 20-050
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ann Chauffe, Louisiana State University Health Sciences Center in New Orleans:
COVID-19
COVID-19 Prophylaxis
Healthcare Workers
SARS-COV-2
Hydroxychloroquine
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents