Clinical trial NCT04334148: Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine
Official title: Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Keywords: 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
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-04-06
Enrollment: 1360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, placebo-controlled, randomized clinical trial.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants With Clinical Infection With COVID-19 Infection
timeFrame: 30 days
Secondary outcomes:
measure: Number of Participants With COVID-19 Viral Shedding
timeFrame: 30 days
measure: Number of Participants With Serious Adverse Events (SAEs) or Hydroxychloroquine-Associated Events of Special Interest (EOSIs)
timeFrame: 30 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado/University of Colorado Denver
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Jacksonville
state: Florida
city: Leesburg
country: United States
facility: University of Florida Health Central Florida
state: Florida
city: Miami
country: United States
facility: University of Miami Florida
state: Florida
city: Orlando
country: United States
facility: Advent Health
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Allina Health
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Hospital Rochester
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Columbia University, Irving Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Sciences
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: Franklin
country: United States
facility: Clinical Trials Center of Middle Tennessee
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center-Temple
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Marshfield
country: United States
facility: Marshfield Clinic Health System
state: Wisconsin
Study officials:
affiliation: Duke University
name: Adrian Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References: