Hydroxychloroquine as Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP) (HCQPreP)
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ClinicalTrials.gov Identifier: NCT04363450 |
Recruitment Status : Unknown
Verified August 2020 by Ann Chauffe, Louisiana State University Health Sciences Center in New Orleans.
Recruitment status was: Recruiting
First Posted : April 27, 2020
Last Update Posted : September 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 Corona Virus Infection Wuhan Coronavirus Prophylaxis Healthcare Worker Sars-CoV2 Hydroxychloroquine | Drug: Hydroxychloroquine Drug: Placebo | Phase 3 |
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 |

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.
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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.
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Drug: Placebo
Loading dose of two placebo capsules twice 12 hours apart followed by 1 capsule twice weekly |
- 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
- 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
- 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 |
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.

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
Contact: Ann D. Chauffe, DO, MPH | 337-261-6161 | achauf@lsuhsc.edu | |
Contact: Rebecca B. Lee, DO, MS | 337-261-6000 | rlee10@lsuhsc.edu |
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 |
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: | 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 |
COVID-19 COVID-19 Prophylaxis Healthcare Workers SARS-COV-2 Hydroxychloroquine |
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 |