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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
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
Masking
None (Open Label)
Masking Description
Open Label

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04354870
Status
Completed
Sponsor
NYU Langone Health

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.