Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine

NCT ID: NCT04334148

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-22
• Study Completion Date: 2021-01-09

Brief Summary

This is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to COVID-19. Eligible participants will be randomly assigned (1:1) to either treatment group (HCQ) or placebo in a double-blind fashion. Course of treatment is 30 days.

Detailed Description

This is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to COVID-19. Eligible participants will be randomly assigned (1:1) to either treatment group (HCQ) or placebo in a double-blind fashion. After enrollment, baseline assessments will include nasopharyngeal swab for COVID-19 and a blood sample to detect seroconversion to COVID-19. For convenience, follow-up will be performed weekly through a direct to participant portal. A call center will provide support for any missed visits. Follow-up includes screening for any COVID-19 clinical infections, other respiratory infections, clinical events, adverse events, and Quality of Life (QoL) assessments. Course of treatment is 30 days. Participants are followed via survey weekly. At the end of treatment participants will return for repeat nasopharyngeal swab for COVID-19 and a blood sample to detect seroconversion to COVID-19. There will be one last contact at 8 weeks (2 months) from baseline.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Hydroxychloroquine

Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.

Group Type: ACTIVE_COMPARATOR

Hydroxychloroquine

Intervention Type: DRUG

oral self administered tablet

Placebo

Matching placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

oral self administered tablet

Interventions

Hydroxychloroquine

oral self administered tablet

Intervention Type: DRUG

Placebo oral tablet

oral self administered tablet

Intervention Type: DRUG

Other Intervention Names

Plaquenil

Eligibility Criteria

Inclusion Criteria

• Completed Informed Consent
• Age ≥ 18 years old
• Currently working in any environment in which there is a risk of exposure to patients with COVID-19 infections ("healthcare worker")

Exclusion Criteria

• Prior diagnosis of COVID-19 infection
• Participation in another COVID-19 prophylaxis trial within 30 days of consent
• Respiratory illness with new-onset fever (Temperature > 100°F) or ongoing cough or dyspnea within 14 days
• Known allergy to HCQ or chloroquine
• Congenital prolonged QT syndrome
• Current or planned use of QT prolonging drugs (e.g. procainamide, disopyramide, mexiletine, flecainide, propafenone, amiodarone, sotalol, cimetidine, dronedarone, dofetilide, levofloxacin, ciprofloxacin, moxifloxacin) and other contraindicated medications
• End stage renal disease
• Pre-existing retinopathy
• Current or planned use of Hydroxychloroquine (study drug) for any indication

Current or planned use of the following for treatment or prevention of COVID-19 infection:

• Chloroquine
• Azithromycin

• Known cirrhosis or severe liver disease
• History of severe skin reactions such as Steven-Johnson syndrome, toxic epidermal necrolysis
• History of psoriasis or porphyria
• Ventricular arrhythmias requiring medical treatment
• Severe coronary artery disease or heart failure/cardiomyopathy with ongoing symptoms
• Current or planned use of use of anti-seizure drugs
• History of Glucose-6-phosphate dehydrogenase deficiency

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Adrian Hernandez

OTHER

Sponsor Role: lead

Responsible Party

Adrian Hernandez

Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Adrian Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Children's Hospital Colorado/University of Colorado Denver

Aurora, Colorado, United States

University of Florida

Gainesville, Florida, United States

University of Florida Jacksonville

Jacksonville, Florida, United States

University of Florida Health Central Florida

Leesburg, Florida, United States

University of Miami Florida

Miami, Florida, United States

Advent Health

Orlando, Florida, United States

University of South Florida

Tampa, Florida, United States

Northwestern Medicine

Chicago, Illinois, United States

Rush University

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Johns Hopkins

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Allina Health

Minneapolis, Minnesota, United States

Mayo Clinic Hospital Rochester

Rochester, Minnesota, United States

University of Missouri-Columbia

Columbia, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Hospital for Special Surgery

New York, New York, United States

Columbia University, Irving Medical Center

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, United States

Clinical Trials Center of Middle Tennessee

Franklin, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor Scott & White Medical Center-Temple

Temple, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

Marshfield Clinic Health System

Marshfield, Wisconsin, United States

Countries

United States

References

Naggie S, Milstone A, Castro M, Collins SP, Lakshmi S, Anderson DJ, Cahuayme-Zuniga L, Turner KB, Cohen LW, Currier J, Fraulo E, Friedland A, Garg J, George A, Mulder H, Olson RE, O'Brien EC, Rothman RL, Shenkman E, Shostak J, Woods CW, Anstrom KJ, Hernandez AF; HERO Research Program. Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ). Int J Infect Dis. 2023 Apr;129:40-48. doi: 10.1016/j.ijid.2023.01.019. Epub 2023 Jan 20.

Reference Type: DERIVED

PMID: 36682681 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Pro00105274

Identifier Type: -

Identifier Source: org_study_id