1. Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection
- Author
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Barnabas, Ruanne V, Brown, Elizabeth R, Bershteyn, Anna, Stankiewicz Karita, Helen C, Johnston, Christine, Thorpe, Lorna E, Kottkamp, Angelica, Neuzil, Kathleen M, Laufer, Miriam K, Deming, Meagan, Paasche-Orlow, Michael K, Kissinger, Patricia J, Luk, Alfred, Paolino, Kristopher, Landovitz, Raphael J, Hoffman, Risa, Schaafsma, Torin T, Krows, Meighan L, Thomas, Katherine K, Morrison, Susan, Haugen, Harald S, Kidoguchi, Lara, Wener, Mark, Greninger, Alexander L, Huang, Meei-Li, Jerome, Keith R, Wald, Anna, Celum, Connie, Chu, Helen Y, and Baeten, Jared M
- Subjects
Clinical Trials and Supportive Activities ,Clinical Research ,Vaccine Related ,Pneumonia ,Emerging Infectious Diseases ,Prevention ,Lung ,Infectious Diseases ,Infection ,Good Health and Well Being ,Adolescent ,Adult ,Aged ,Aged ,80 and over ,Antiviral Agents ,COVID-19 ,COVID-19 Nucleic Acid Testing ,Double-Blind Method ,Female ,Humans ,Hydroxychloroquine ,Male ,Middle Aged ,Post-Exposure Prophylaxis ,SARS-CoV-2 ,Time Factors ,Treatment Outcome ,United States ,Young Adult ,COVID-19 Drug Treatment ,Hydroxychloroquine COVID-19 PEP Study Team ,Clinical Sciences ,Public Health and Health Services - Abstract
BackgroundEffective prevention against coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is currently limited to nonpharmaceutical strategies. Laboratory and observational data suggested that hydroxychloroquine had biological activity against SARS-CoV-2, potentially permitting its use for prevention.ObjectiveTo test hydroxychloroquine as postexposure prophylaxis for SARS-CoV-2 infection.DesignHousehold-randomized, double-blind, controlled trial of hydroxychloroquine postexposure prophylaxis. (ClinicalTrials.gov: NCT04328961).SettingNational U.S. multicenter study.ParticipantsClose contacts recently exposed ( 0.20). The frequency of participants experiencing adverse events was higher in the hydroxychloroquine group than the control group (66 [16.2%] versus 46 [10.9%], respectively; P = 0.026).LimitationThe delay between exposure, and then baseline testing and the first dose of hydroxychloroquine or ascorbic acid, was a median of 2 days.ConclusionThis rigorous randomized controlled trial among persons with recent exposure excluded a clinically meaningful effect of hydroxychloroquine as postexposure prophylaxis to prevent SARS-CoV-2 infection.Primary funding sourceBill & Melinda Gates Foundation.
- Published
- 2021