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.

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.

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

Plan description: HERO-HCQ is funded by PCORI, the Patient-Centered Outcomes Research Institute. PCORI calls for the researchers PCORI funds to share their data sets and documentation for reanalysis and reuse. The policy advances PCORI's commitment to open science by encouraging use of data from the studies it funds to allow other researchers to verify and build on those findings to generate new evidence available to healthcare decision makers.

July 2022

Individual investigators or teams of investigators seeking access to data from PCORI-funded studies must complete and submit a data request form to a PCORI-designated repository. The repository will independently review requests for data based on qualifications of the data requestors and the scientific merit of the request (see below). If the data request is approved, the data requestor's institution must enter into a Data Use Agreement (DUA) with the repository. More information is available here https://www.pcori.org/about-us/governance/policy-data-management-and-data-sharing

Double-blind