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

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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

Tracking Information
First Submitted Date  ICMJE April 2, 2020
First Posted Date  ICMJE April 6, 2020
Results First Submitted Date  ICMJE October 1, 2021
Results First Posted Date  ICMJE October 7, 2021
Last Update Posted Date October 12, 2021
Actual Study Start Date  ICMJE April 22, 2020
Actual Primary Completion Date December 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2020)
Number of participants testing positive for COVID-19 infection [ Time Frame: 30 days ]
Number of participants testing positive for COVID-19 infection(hydroxychloroquine vs placebo)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2021)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2020)
  • Number of participants with COVID-19 viral shedding [ Time Frame: 30 days ]
    Number of participants with COVID-19 infection shedding (hydroxychloroquine vs placebo)
  • Safety as measured by number of adverse events [ Time Frame: 30 days ]
    Safety as measured by number of adverse events (hydroxychloroquine vs placebo)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine
Official Title  ICMJE Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Hydroxychloroquine
    oral self administered tablet
    Other Name: Plaquenil
  • Drug: Placebo oral tablet
    oral self administered tablet
Study Arms  ICMJE
  • Active Comparator: Hydroxychloroquine
    Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.
    Intervention: Drug: Hydroxychloroquine
  • Placebo Comparator: Placebo
    Matching placebo tablets
    Intervention: Drug: Placebo oral tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2021)
1360
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2020)
15000
Actual Study Completion Date  ICMJE January 9, 2021
Actual Primary Completion Date December 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04334148
Other Study ID Numbers  ICMJE Pro00105274
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party Adrian Hernandez, Duke University
Study Sponsor  ICMJE Adrian Hernandez
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Adrian Hernandez, MD Duke University
PRS Account Duke University
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP