COVID-19 PrEP HCW HCQ Study

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Hydroxychloroquine (HCQ)

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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HCQ Group; Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ	Drug: Hydroxychloroquine (HCQ); Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
No Intervention: Control Group; 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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: H. Michael Belmont, MD, NYU Langone Health

Publications and helpful links

General Publications

• 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.

Helpful Links

• DOI: https://doi.org/10.29011/2577-1515.100201.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2020
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Hydroxychloroquine
• Other Study ID Numbers: s20-00390

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Study internal to NYU at this time

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes