COVID-19 PrEP HCW HCQ Study

• Status: Completed
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NYU Langone Health
• Treatments: Hydroxychloroquine

Criteria

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)