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

NCT04363450 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: LSU NO HSC IRB 20-050
• Study Type: interventional
• Target: 1,700
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (2)

• Absenteeism from work due to COVID-19

  12 weeks

• Severity of COVID-19 infection

  12 weeks

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Hydroxychloroquine DRUG

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

Also known as: HCQ PreP

Hydroxychloroquine

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• Lafayette General Health: collaborator
• University of Louisiana at Lafayette: collaborator

Study Sites (2)

Lafayette General Medical Center

Lafayette, Louisiana, 70503, United States

RECRUITING

University Hospital and Clinics

Lafayette, Louisiana, 70506, United States

RECRUITING

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Ann D. Chauffe, DO, MPH

CONTACT

337-261-6161; achauf@lsuhsc.edu

Rebecca B. Lee, DO, MS

CONTACT

337-261-6000; rlee10@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DO, MPH

Model Details: Randomized, placebo-controlled, double-blind study with 1:1 randomization of hydroxychloroquine to placebo

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: April 27, 2020
• Primary Completion: March 31, 2021
• Study Completion: June 1, 2021
• Last Updated: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)