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Trial record 10 of 17 for:    prophylaxis, hydroxychloroquine | covid-19 | United States

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04354870
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 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
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Frequency of seroconversion to SARS-CoV-2 [ Time Frame: baseline, 30 days, 60 days, 90 days ]
    Antibody titers will be measured to determine seroconversion, a binomial endpoint defined by a four-fold increase in antibody titers compared to baseline.


Secondary Outcome Measures :
  1. Incidence of COVID-19 symptoms in the 4 weeks preceding seroconversion [ Time Frame: baseline, 30 days, 60 days, 90 days ]
    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)

  2. Hospital admission rate [ Time Frame: baseline, 30 days, 60 days, 90 days ]
    Data collection from medical chart review

  3. ICU admission rate [ Time Frame: baseline, 30 days, 60 days, 90 days ]
    Data collection from medical chart review

  4. Mortality rate [ Time Frame: baseline, 30 days, 60 days, 90 days ]
    Data collection from medical chart review

  5. Incidents of AEs or SAEs related to HCQ upon study termination time [ Time Frame: 30 days, 60 days, 90 days ]
    To assess the tolerability of hydroxychloroquine SARS-CoV-2 PrEP in this population


Other Outcome Measures:
  1. Percentage of cells infected in the laboratory using a standardized dose of pseudotyped SARS-CoV-2 in the presence or absence of blood containing non-SARS-CoV-2 coronaviruses antibodies [ Time Frame: baseline, 30 days, 60 days, 90 days ]
    Measured by Serology test, to characterize whether pre-existing of non-SARS-CoV-2 coronavirus antibodies are capable of causing antibody dependent enhancement of a pseudotyped SARS-CoV-2

  2. Days away from work [ Time Frame: baseline, 30 days, 60 days, 90 days ]
    To determine whether hydroxychloroquine reduces time lost from work

  3. Frequency of missing HCQ dose [ Time Frame: baseline, 30 days, 60 days, 90 days ]
    To assess the compliance of hydroxychloroquine PrEP



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)

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


Contacts
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Contact: Emily Beato +1 212 263 6411 emily.beato@nyulangone.org
Contact: Lisa Zhao Lisa.Zhao@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Emily Beato         
Principal Investigator: Michael Belmont, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Michael Belmont, MD NYU Langone Health

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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
Last Update Posted: April 22, 2020
Last Verified: April 2020
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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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents