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

Completed · Phase 2

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04345653

Run by

Hackensack Meridian Health

People needed

48

Starts

2020-04-14

Expected to finish

2021-05-10

Last updated by the study team

2021-05-12

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hackensack Meridian Health - JFK Medical Center — Edison, New Jersey, United States

Full record on ClinicalTrials.gov

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