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

Adrian Hernandez

Status and phase: Completed; Phase 3

Conditions: COVID-19

Treatments: Drug: Placebo oral tablet; Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04334148

Pro00105274

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,360 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

1,360 participants in 2 patient groups, including a placebo group

Hydroxychloroquine

Active Comparator group

Description:

Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.

Treatment:

Drug: Hydroxychloroquine

Placebo

Placebo Comparator group

Description:

Matching placebo tablets

Treatment:

Drug: Placebo oral tablet