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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334148
Recruitment Status : Completed
First Posted : April 6, 2020
Results First Posted : October 7, 2021
Last Update Posted : October 12, 2021
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Adrian Hernandez, Duke University

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Drug: Placebo oral tablet Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind, placebo-controlled, randomized clinical trial.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind
Primary Purpose: Prevention
Official Title: Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial)
Actual Study Start Date : April 22, 2020
Actual Primary Completion Date : December 10, 2020
Actual Study Completion Date : January 9, 2021


Arm Intervention/treatment
Active Comparator: Hydroxychloroquine
Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.
Drug: Hydroxychloroquine
oral self administered tablet
Other Name: Plaquenil

Placebo Comparator: Placebo
Matching placebo tablets
Drug: Placebo oral tablet
oral self administered tablet




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT04334148


Locations
Show Show 34 study locations
Sponsors and Collaborators
Adrian Hernandez
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Adrian Hernandez, MD Duke University
  Study Documents (Full-Text)

Documents provided by Adrian Hernandez, Duke University:
Study Protocol  [PDF] July 7, 2020
Statistical Analysis Plan  [PDF] September 4, 2020

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Responsible Party: Adrian Hernandez, Professor of Medicine, Duke University
ClinicalTrials.gov Identifier: NCT04334148    
Other Study ID Numbers: Pro00105274
First Posted: April 6, 2020    Key Record Dates
Results First Posted: October 7, 2021
Last Update Posted: October 12, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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
URL: http://www.pcori.org

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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
Keywords provided by Adrian Hernandez, Duke University:
Hydroxychloroquine
Coronavirus Infections
Novel Coronavirus
Protective agents
Prophylaxis
Chemoprophylaxis
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Virus Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Lung Injury
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Chloroquine
Chloroquine diphosphate
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
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