Clinical trial NCT04354870: COVID-19 PrEP HCW HCQ Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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

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.

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

  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)

Primary outcomes:
measure: Change From Baseline in the Number of Participants With Seroconversion to SARS-CoV-2 at 1 Month
timeFrame: Baseline to 1 month post-baseline
measure: Number of Participants With Symptomatic vs. Asymptomatic Seroconversion
timeFrame: 4 Weeks Prior to Baseline
Secondary outcomes:
measure: Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time
timeFrame: Day 90
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: H. Michael Belmont, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raabe VN, Fleming A, Samanovic MI, Lai L, Belli HM, et al. (2022) Hydroxychloroquine Pre-Exposure Prophylaxis to Prevent SARS-CoV-2 Among Health Care Workers at High Risk For SARS-CoV-2 Exposure: A Nonrandomized Controlled Trial. Infect Dis Diag Treat 6: 201.