COVID-19 PrEP HCW HCQ Study

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: Hydroxychloroquine (HCQ)

• Registration Number: NCT04354870
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-04-03
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-21
• Primary Completion: 2020-09-15
• Study Completion: 2020-10-01
• Results First Submitted: 2021-09-29
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-04
• Results First Posted: 2021-10-06
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCQ Group	Hydroxychloroquine (HCQ)	Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ

Primary Outcome Measures

Name	Time	Method
Number of Participants With Symptomatic vs. Asymptomatic Seroconversion	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).
Change From Baseline in the Number of Participants With Seroconversion to SARS-CoV-2 at 1 Month	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time	Day 90	To assess the tolerability of hydroxychloroquine SARS-CoV-2 PrEP in this population

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States