COVID-19 PrEP HCW HCQ Study

NYU Langone Health130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

COVID-19

Interventions

Hydroxychloroquine (HCQ)DRUG

Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 4 Weeks Prior to Baseline

Secondary Outcomes

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

Time frame: Day 90

Data from ClinicalTrials.gov

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