Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine
HERO-HCQ
1 other identifier
interventional
1,360
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 covid19
Started Apr 2020
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2020
CompletedFirst Posted
Study publicly available on registry
April 6, 2020
CompletedStudy Start
First participant enrolled
April 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2021
CompletedResults Posted
Study results publicly available
October 7, 2021
CompletedOctober 12, 2021
October 1, 2021
8 months
April 2, 2020
October 1, 2021
October 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Clinical Infection With COVID-19 Infection
This measure was a combination of confirmed infection and suspected infection. Confirmed clinical infection was defined as new-onset of fever or cough or dyspnea AND confirmed COVID-19 positive test result via local PCRI testing. Suspected infection was defined as new-onset fever or cough or dyspnea without local PCR testing due to local restrictions and/or testing policies.
30 days
Secondary Outcomes (2)
Number of Participants With COVID-19 Viral Shedding
30 days
Number of Participants With Serious Adverse Events (SAEs) or Hydroxychloroquine-Associated Events of Special Interest (EOSIs)
30 days
Study Arms (2)
Hydroxychloroquine
ACTIVE COMPARATORHydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.
Placebo
PLACEBO COMPARATORMatching placebo tablets
Interventions
Eligibility Criteria
You may qualify if:
- 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")
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Adrian Hernandezlead
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (34)
Children's Hospital Colorado/University of Colorado Denver
Aurora, Colorado, 80045, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Florida Jacksonville
Jacksonville, Florida, 32206, United States
University of Florida Health Central Florida
Leesburg, Florida, 34748, United States
University of Miami Florida
Miami, Florida, 33136, United States
Advent Health
Orlando, Florida, 32804, United States
University of South Florida
Tampa, Florida, 33606, United States
Northwestern Medicine
Chicago, Illinois, 60611, United States
Rush University
Chicago, Illinois, 60612, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Johns Hopkins
Baltimore, Maryland, 21287, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Allina Health
Minneapolis, Minnesota, 55404, United States
Mayo Clinic Hospital Rochester
Rochester, Minnesota, 55905, United States
University of Missouri-Columbia
Columbia, Missouri, 65212, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Columbia University, Irving Medical Center
New York, New York, 10032, United States
Weill Cornell Medicine
New York, New York, 10065, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, 27157, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213, United States
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, 37067, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor Scott & White Medical Center-Temple
Temple, Texas, 76504, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Marshfield Clinic Health System
Marshfield, Wisconsin, 54449, United States
Related Publications (1)
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.
PMID: 36682681DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was underpowered to detect a small treatment effect. The trial was novel and improved feasibility, particularly during a pandemic. Testing was not performed at all institutions per local policies in HCW. These events were defined as suspected cases and were combined with the confirmed cases in the primary outcome. This resulted in few confirmed COVID-19 infections; thus, our primary outcome was primarily suspected COVID-19 clinical infection.
Results Point of Contact
- Title
- Dr. Susanna Naggie
- Organization
- Duke University
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian Hernandez, MD
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
April 2, 2020
First Posted
April 6, 2020
Study Start
April 22, 2020
Primary Completion
December 10, 2020
Study Completion
January 9, 2021
Last Updated
October 12, 2021
Results First Posted
October 7, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- July 2022
- Access Criteria
- Individual investigators or teams of investigators seeking access to data from PCORI-funded studies must complete and submit a data request form to a PCORI-designated repository. The repository will independently review requests for data based on qualifications of the data requestors and the scientific merit of the request (see below). If the data request is approved, the data requestor's institution must enter into a Data Use Agreement (DUA) with the repository. More information is available here https://www.pcori.org/about-us/governance/policy-data-management-and-data-sharing
Plan description: HERO-HCQ is funded by PCORI, the Patient-Centered Outcomes Research Institute. PCORI calls for the researchers PCORI funds to share their data sets and documentation for reanalysis and reuse. The policy advances PCORI's commitment to open science by encouraging use of data from the studies it funds to allow other researchers to verify and build on those findings to generate new evidence available to healthcare decision makers.