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COVID-19 PrEP HCW HCQ Study

NCT ID: NCT04354870

Last Updated: 2022-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-03

Study Completion Date

2020-10-01

Brief Summary

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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

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Open Label

Study Groups

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HCQ Group

Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ

Group Type EXPERIMENTAL

Hydroxychloroquine (HCQ)

Intervention Type DRUG

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

Control Group

approximately 50 HCW who choose not to be provided HCQ

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hydroxychloroquine (HCQ)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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H. Michael Belmont, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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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

DOI: https://doi.org/10.29011/2577-1515.100201.

Other Identifiers

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s20-00390

Identifier Type: -

Identifier Source: org_study_id