Recruiting
Phase 3

Hydroxychloroquine

Sponsor:

Louisiana State University Health Sciences Center in New Orleans

Code:

NCT04363450

Conditions

COVID-19

Corona Virus Infection

Wuhan Coronavirus

Prophylaxis

Healthcare Worker

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Hydroxychloroquine

Placebo

Study Details

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

Study ID

NCT04363450

Start date

Apr 27, 2020

Status verified date

Aug, 2020

Completion date

Jun 1, 2021

Anticipated

Primary completion date

Mar 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

1700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

placebo comparator: Placebo

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

Interventions

Hydroxychloroquine

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

Placebo

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

Primary outcome measure

  • Incidence of symptomatic COVID-19 infection in healthcare workers [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Ann D. Chauffe, DO, MPH

337-261-6161achauf@lsuhsc.edu

Rebecca B. Lee, DO, MS

337-261-6000rlee10@lsuhsc.edu

Locations

Lafayette General Medical Center

Recruiting

Lafayette, Louisiana, United States, 70503

Contacts

Ann D Chauffe, DO, MPH

337-261-6000achauf@lsuhsc.edu

Principal Investigator:

Ann D Chauffe, DO, MPH

University Hospital and Clinics

Recruiting

Lafayette, Louisiana, United States, 70506

Contacts

Ann D Chauffe, DO, MPH

337-261-6000achauf@lsuhsc.edu

Principal Investigator:

Ann D Chauffe, DO, MPH

More Information

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Last update posted

Sep 2, 2020

Last verified

Aug, 2020

Keywords

  • COVID-19
  • COVID-19 Prophylaxis
  • Healthcare Workers
  • SARS-COV-2
  • Hydroxychloroquine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louisiana State University Health Sciences Center in New Orleans on 2020-09-02.