Status:
COMPLETED
COVID-19 PrEP HCW HCQ Study
Lead Sponsor:
NYU Langone Health
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Off label study to evaluate the efficacy of HCQ for pre-exposure prophylaxis (PrEP) to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. 350 participants will be assigned...
Detailed Description
Hydroxychloroquine (HCQ) is licensed for the chemoprophylaxis and treatment of malaria and as a disease modifying antirheumatic drug. It has a long history of being safe and well tolerated at typical ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Group A and B
- Men or women ages ≥18 years NYULH health care worker who meets one of the following criteria
- Involved in an aerosol generating procedure (nasopharyngeal specimen collection, tracheal intubation, nebulizer treatment, open airway suctioning, collection of sputum, tracheostomy, bronchoscopy, CPR) on a confirmed COVID-19 patient while wearing PPE
- Direct bedside care of confirmed COVID-19 patient while wearing PPE for 3 or more shifts in a 7 day period
- Direct care of PUIs in the ED or other inpatient unit while wearing PPE for 3 or more shifts in a 7 day period
- Willing and able to provide informed consent
- Exclusion Criteria for Group A only :
- Known hypersensitivity to hydroxychloroquine or chloroquine
- Known diagnosis of COVID-19
- Concomitant use of
- amiodarone
- digoxin
- flecainide
- procainamide
- propafenone
- History of Torsades de pontes
- History of retinal disease
- Known chronic kidney disease ≥ stage 4
- Congenital prolonged QTc interval syndrome (Jervell and Lange-Nielsen syndrome, Romano-Ward syndrome)
Exclusion
Key Trial Info
Start Date :
April 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04354870
Start Date
April 3 2020
End Date
October 1 2020
Last Update
December 14 2022
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016