COVID-19 PrEP HCW HCQ Study
Purpose
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 to the group that takes HCQ or the group that opts to not take the study medication. Participants will be NYULH HCW at high risk for occupational exposure to SARS-CoV-2. Study timepoints will include screening/enrollment, 30 day, 60 day, and 90 day visits. Questionnaires, and DBS will be collected in all timepoints.
Condition
- COVID-19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
for Group A and B - Men or women ages ≥18 years NYULH health care worker who meets one of the following criteria 1. 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 2. Direct bedside care of confirmed COVID-19 patient while wearing PPE for 3 or more shifts in a 7 day period 3. 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 1. amiodarone 2. digoxin 3. flecainide 4. procainamide 5. 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)
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Total number of participant: 350 (Group A and B) - Group A: projected 300 (HCW choose to be provided HCQ) - Group B: projected 50 (HCW choose not to be provided HCQ)
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- Open Label
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental HCQ Group |
Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ |
|
No Intervention Control Group |
approximately 50 HCW who choose not to be provided HCQ |
|
Recruiting Locations
More Details
- NCT ID
- NCT04354870
- Status
- Completed
- Sponsor
- NYU Langone Health
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 doses. HCQ has antiviral activity in vitro against coronaviruses, and specifically Covid-19. This study is designed to evaluate the efficacy of hydroxychloroquine (HCQ) for pre exposure prophylaxis (PrEP) to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among health care workers at high risk of occupational exposure to SARS-CoV-2 compared to the eligible cohort that declines treatment.