Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ)

October 8, 2021 updated by: Adrian Hernandez

Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

1360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado/University of Colorado Denver
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Jacksonville, Florida, United States, 32206
        • University of Florida Jacksonville
      • Leesburg, Florida, United States, 34748
        • University of Florida Health Central Florida
      • Miami, Florida, United States, 33136
        • University of Miami Florida
      • Orlando, Florida, United States, 32804
        • Advent Health
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University
      • Chicago, Illinois, United States, 60611
        • Northwestern Medicine
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Allina Health
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Hospital Rochester
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri-Columbia
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
      • New York, New York, United States, 10032
        • Columbia University, Irving Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health Sciences
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh School of Medicine
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Clinical Trials Center of Middle Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Temple, Texas, United States, 76504
        • Baylor Scott & White Medical Center-Temple
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Hydroxychloroquine
Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.
oral self administered tablet
Other Names:
  • Plaquenil
PLACEBO_COMPARATOR: Placebo
Matching placebo tablets
oral self administered tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Infection With COVID-19 Infection
Time Frame: 30 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With COVID-19 Viral Shedding
Time Frame: 30 days
Number of participants with COVID-19 infection shedding via Covance swab PCR testing
30 days
Number of Participants With Serious Adverse Events (SAEs) or Hydroxychloroquine-Associated Events of Special Interest (EOSIs)
Time Frame: 30 days
Safety and Tolerability as determined by subject reported serious adverse events (SAEs) and hydroxychloroquine-associated events of special interest. EOSIs include: arrhythmias (ventricular), hepatic failure, bone marrow failure, aplastic anemia, prolonged QT interval, angioedema, dermatitis exfoliative, acute generalized exanthematous pustulosis, psychosis, suicidal ideation, seizure, methemoglobinemia.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 22, 2020

Primary Completion (ACTUAL)

December 10, 2020

Study Completion (ACTUAL)

January 9, 2021

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (ACTUAL)

April 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 8, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

July 2022

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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