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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334148
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : May 14, 2020
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 15,000 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 15,000 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)
Estimated Enrollment : 15000 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
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020


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 ]
    Number of participants with clinical infection with COVID-19 infection(hydroxychloroquine vs placebo)


Secondary Outcome Measures :
  1. Number of participants with COVID-19 viral shedding [ Time Frame: 30 days ]
    Number of participants with COVID-19 infection shedding (hydroxychloroquine vs placebo)

  2. Safety as measured by number of adverse events [ Time Frame: 30 days ]
    Safety as measured by number of adverse events (hydroxychloroquine vs placebo)



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
  • Individual is currently working with a trial participating site where individuals receive healthcare ("healthcare worker") or is associated with the site through emergency services or related healthcare services
  • Able to speak and read English or Spanish
  • At risk for COVID-19 infection through one or more of the following work exposures:

    • in the Intensive care unit, or
    • in the Emergency department, or
    • in Emergency services, or
    • in a COVID-19 hospital unit/ward, or
    • in respiratory services, or
    • in COVID-19 testing location
    • in inpatient hospital unit/area with potential COVID-19 cases

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)
  • End stage renal disease
  • Pre-existing retinopathy
  • Current or planned use of the following for treatment or prevention of COVID-19 infection:

    • Hydroxychloroquine (study drug) or 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


Contacts
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Contact: Rachel Olson, RN 919-668-5590 rachel.e.olson@duke.edu
Contact: Donna Parker 919-668-4084 donna.l.parker@duke.edu

Locations
Show Show 17 study locations
Sponsors and Collaborators
Adrian Hernandez
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Adrian Hernandez, MD Duke University
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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
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents