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COVID-19 PrEP HCW HCQ Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04354870
Recruitment Status : Completed
First Posted : April 21, 2020
Results First Posted : October 6, 2021
Last Update Posted : December 14, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine (HCQ) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
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)
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
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
Actual Study Start Date : April 3, 2020
Actual Primary Completion Date : September 15, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in the Number of Participants With Seroconversion to SARS-CoV-2 at 1 Month [ Time Frame: Baseline to 1 month post-baseline ]
    Antibody titers will be measured to determine seroconversion, a binomial endpoint defined by a four-fold increase in antibody titers compared to baseline.

  2. Number of Participants With Symptomatic vs. Asymptomatic Seroconversion [ Time Frame: 4 Weeks Prior to Baseline ]
    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 :
  1. Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time [ Time Frame: Day 90 ]
    To assess the tolerability of hydroxychloroquine SARS-CoV-2 PrEP in this population


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354870


Locations
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United States, New York
NYU Langone Health
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: H. Michael Belmont, MD NYU Langone Health
  Study Documents (Full-Text)

Documents provided by NYU Langone Health:
Study Protocol and Statistical Analysis Plan  [PDF] August 25, 2020

More Information
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Additional Information:

Publications of Results:
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.

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04354870    
Other Study ID Numbers: s20-00390
First Posted: April 21, 2020    Key Record Dates
Results First Posted: October 6, 2021
Last Update Posted: December 14, 2022
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study internal to NYU at this time

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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
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents