NYU Langone Health
New York, 10016, United States
NCT Number: NCT04354870
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
New York, 10016, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Group A and B
Exclusion criteria
for Group A only :
Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
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.
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).
Time frame: Day 90
To assess the tolerability of hydroxychloroquine SARS-CoV-2 PrEP in this population
NYU Langone Health
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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