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.
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.
Drug: Hydroxychloroquine (HCQ)
Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
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)
NYU Langone Health
New York, New York, United States
H. Michael Belmont, MD, Principal Investigator
NYU Langone Health