Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine

COVID-19 Clinical Trial

— HERO-HCQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334148
• Other study ID #: Pro00105274
• Status: Completed
• Phase: Phase 3
• Start date: April 22, 2020
• Est. completion date: January 9, 2021

Study information

• Verified date: October 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1360
• Est. completion date: January 9, 2021
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Hydroxychloroquine
oral self administered tablet
• Placebo oral tablet
oral self administered tablet

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Children's Hospital Colorado/University of Colorado Denver	Aurora	Colorado
United States	Johns Hopkins	Baltimore	Maryland
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern Medicine	Chicago	Illinois
United States	Rush University	Chicago	Illinois
United States	University of Missouri-Columbia	Columbia	Missouri
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Clinical Trials Center of Middle Tennessee	Franklin	Tennessee
United States	University of Florida	Gainesville	Florida
United States	University of Iowa	Iowa City	Iowa
United States	University of Florida Jacksonville	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Florida Health Central Florida	Leesburg	Florida
United States	Marshfield Clinic Health System	Marshfield	Wisconsin
United States	University of Miami Florida	Miami	Florida
United States	Allina Health	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	Columbia University, Irving Medical Center	New York	New York
United States	Hospital for Special Surgery	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Advent Health	Orlando	Florida
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania
United States	Mayo Clinic Hospital Rochester	Rochester	Minnesota
United States	Seattle Children's Hospital	Seattle	Washington
United States	University of South Florida	Tampa	Florida
United States	Baylor Scott & White Medical Center-Temple	Temple	Texas
United States	Wake Forest Baptist Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Adrian Hernandez	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinical Infection With COVID-19 Infection	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	Number of Participants With COVID-19 Viral Shedding	Number of participants with COVID-19 infection shedding via Covance swab PCR testing	30 days
Secondary	Number of Participants With Serious Adverse Events (SAEs) or Hydroxychloroquine-Associated Events of Special Interest (EOSIs)	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