Back to resultsCOVID-19 PrEP HCW HCQ Study
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine (HCQ)
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
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)
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HCQ Group
Control Group
Arm Description
Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ
approximately 50 HCW who choose not to be provided HCQ
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04354870
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 3, 2020 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Masking Description
Open Label
Allocation
Non-Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HCQ Group
Arm Type
Experimental
Arm Description
Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
approximately 50 HCW who choose not to be provided HCQ
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine (HCQ)
Intervention Description
Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
Primary Outcome Measure Information:
Title
Change From Baseline in the Number of Participants With Seroconversion to SARS-CoV-2 at 1 Month
Description
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
Title
Number of Participants With Symptomatic vs. Asymptomatic Seroconversion
Description
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 Outcome Measure Information:
Title
Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time
Description
To assess the tolerability of hydroxychloroquine SARS-CoV-2 PrEP in this population
Time Frame
Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Michael Belmont, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study internal to NYU at this time
Citations:
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.
Results Reference
result
Links:
URL
https://www.gavinpublishers.com/article/view/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
Description
DOI: https://doi.org/10.29011/2577-1515.100201.
Learn more about this trial
COVID-19 PrEP HCW HCQ Study
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