COVID-19 PrEP HCW HCQ Study

Study Overview
=================
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 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.

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.

Official Title
-----------------
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 Among Health Care Workers (HCWs) Who Are at High Risk of Occupational Exposure to SARS-CoV-2

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Drug: Hydroxychloroquine (HCQ)


Participation Criteria
=================
Eligibility 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 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCQ Group<br>Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ | Drug: Hydroxychloroquine (HCQ)<br>* Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days<br>|
| No Intervention: Control Group<br>approximately 50 HCW who choose not to be provided HCQ | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Number of Participants With Seroconversion to SARS-CoV-2 at 1 Month | Antibody titers will be measured to determine seroconversion, a binomial endpoint defined by a four-fold increase in antibody titers compared to baseline. | Baseline to 1 month post-baseline | 
| Number of Participants With Symptomatic vs. Asymptomatic Seroconversion | To characterize whether high-risk HCW who seroconvert to SARS-CoV-2 have asymptomatic infection or report symptoms of COVID-19 in the 4 weeks preceding seroconversion (assessed by symptom questionnaire). | 4 Weeks Prior to Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time | To assess the tolerability of hydroxychloroquine SARS-CoV-2 PrEP in this population | Day 90 |