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

• ClinicalTrials.gov Identifier: NCT04363450
• Recruitment Status: Unknown
• First Posted: April 27, 2020
• Last Update Posted: September 2, 2020
• Sponsor: Louisiana State University Health Sciences Center in New Orleans
• 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

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.

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.

Study Design

• 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: March 31, 2021
• Estimated Study Completion Date: June 1, 2021

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

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

More Information

• 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
• Last Update Posted: September 2, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

COVID-19; Coronavirus Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Hydroxychloroquine; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents