Status:
COMPLETED
Hydroxychloroquine as Chemoprevention for COVID-19 for High Risk Healthcare Workers
Lead Sponsor:
Hackensack Meridian Health
Conditions:
Covid19
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief 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 acut...
Detailed Description
Given the lack of data regarding use of HCQ for COVID-19 prevention in healthy participants in midst of pandemic crisis, this study proposes an expedited feasibility study focusing on safety and early...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04345653
Start Date
April 14 2020
End Date
May 10 2021
Last Update
May 12 2021
Active Locations (1)
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1
Hackensack Meridian Health - JFK Medical Center
Edison, New Jersey, United States, 08820