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

• ClinicalTrials.gov Identifier: NCT04334148
• Recruitment Status: Completed
• First Posted: April 6, 2020
• Last Update Posted: March 25, 2021
• Sponsor: Adrian Hernandez
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Adrian Hernandez, Duke University

Tracking Information

• First Submitted Date: April 2, 2020
• First Posted Date: April 6, 2020
• Last Update Posted Date: March 25, 2021
• Actual Study Start Date: April 22, 2020
• Actual Primary Completion Date: December 10, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 13, 2020)

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)

Original Primary Outcome Measures (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)

Current Secondary Outcome Measures (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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine
• Official Title: 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: Interventional
• Study Phase: Phase 3

Study Design

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: COVID-19

Intervention

• Drug: Hydroxychloroquine
  oral self administered tablet
  Other Name: Plaquenil
• Drug: Placebo oral tablet
  oral self administered tablet

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 9, 2020): 1363
• Original Estimated Enrollment (submitted: April 2, 2020): 15000
• Actual Study Completion Date: January 9, 2021
• Actual Primary Completion Date: December 10, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04334148
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Adrian Hernandez, Duke University
• Study Sponsor: Adrian Hernandez
• Collaborators: Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Adrian Hernandez, MD; Duke University

• PRS Account: Duke University
• Verification Date: March 2021