Hydroxychloroquine as Chemoprevention for COVID-19 for High Risk Healthcare Workers

• Status: Completed
• Trial end date: 2021-05-10
• Target enrollment: 0
• Participant gender: All

Summary

The study proposes to conduct an open-label Phase II trial to evaluate the feasibility, safety and early efficacy of hydroxychloroquine (HCQ) administration in reduction of transmission of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and development of Corona Virus Disease 2019 (COVID-19) in high-risk, healthy acute care provider participants exposed, directly or indirectly, to COVID-19 patients. There is a more than 50 years track record of safety of HCQ for treatment and prevention of various disease states. Early data on use of HCQ for COVID treatment suggests anti-viral activity and immunomodulatory properties for reducing inflammation associated with COVID-19.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hackensack Meridian Health
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

• Volunteers ages 18 to 99 years,

• Able to sign own informed consent form,

• Considered high-risk healthcare care providers in a hospital setting with active exposure to COVID-19 infection.

High-risk healthcare providers are defined as those actively working during the study duration in the Emergency Department and in the Intensive Care Setting, for the purpose of this study.

Exclusion Criteria:

• Inability to tolerate an oral medication or known allergy to chloroquine or hydroxychloroquine

• Pregnancy or breast-feeding

• Immunocompromised status, hepatic failure, electrolytic imbalance

• Creatinine clearance (CCL) <30 mL/min

• Prolonged QT interval (QTc > 450ms for males and QTc > 470 for females)

• Confirmed COVID-19 infection on baseline testing

• Has another known contraindication to treatment with the study drug, including retinopathy.