- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04334148
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
Intervention / Treatment
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
-
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Colorado
-
Aurora, Colorado, United States, 80045
- Children's Hospital Colorado/University of Colorado Denver
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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Jacksonville, Florida, United States, 32206
- University of Florida Jacksonville
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Leesburg, Florida, United States, 34748
- University of Florida Health Central Florida
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Miami, Florida, United States, 33136
- University of Miami Florida
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Orlando, Florida, United States, 32804
- Advent Health
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Tampa, Florida, United States, 33606
- University of South Florida
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush University
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Chicago, Illinois, United States, 60611
- Northwestern Medicine
-
-
Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Clinic Foundation
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New Orleans, Louisiana, United States, 70112
- University Medical Center New Orleans
-
-
Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55404
- Allina Health
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Hospital Rochester
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri-Columbia
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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New York
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New York, New York, United States, 10065
- Weill Cornell Medicine
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New York, New York, United States, 10021
- Hospital for Special Surgery
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New York, New York, United States, 10032
- Columbia University, Irving Medical Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Health Sciences
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University Wexner Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Temple University Hospital
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh School of Medicine
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Tennessee
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Franklin, Tennessee, United States, 37067
- Clinical Trials Center of Middle Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
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Temple, Texas, United States, 76504
- Baylor Scott & White Medical Center-Temple
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Washington
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Seattle, Washington, United States, 98105
- Seattle Children's Hospital
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic Health System
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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:
|
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.
Sponsor
Collaborators
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
Keywords
- Coronavirus Infections
- Respiratory Tract Diseases
- Anti-Infective Agents
- Virus Diseases
- Lung Diseases
- Respiratory Tract Infections
- Coronaviridae Infections
- Nidovirales Infections
- Enzyme Inhibitors
- Prophylaxis
- Novel Coronavirus
- Chloroquine
- Hydroxychloroquine
- Chemoprophylaxis
- RNA Virus Infections
- Acute Lung Injury
- Respiration Disorders
- Severe Acute Respiratory Syndrome
- Molecular Mechanisms of Pharmacological Action
- Lung Injury
- Antimalarials
- Antirheumatic Agents
- Antiparasitic Agents
- Antiprotozoal Agents
- Protective agents
- Respiratory Distress Syndrome, Adult
- Chloroquine diphosphate
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00105274
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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