drugset / Trial / NCT04354870

COVID-19 PrEP HCW HCQ Study

NCT04354870

Phase 2 Completed 130 enrolled NYU Langone Health
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-04-03
Primary completion
2020-09-15
Completion
2020-10-01

Publications

  • 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.

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxychloroquine Small molecule 200 mg Oral

Indications