期刊
NEW ENGLAND JOURNAL OF MEDICINE
卷 383, 期 6, 页码 517-525出版社
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa2016638
关键词
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资金
- Alliance of Minnesota Chinese Organizations
- Minnesota Chinese Chamber of Commerce
- University of Minnesota
- Doris Duke Charitable Foundation through the Doris Duke International Clinical Research Fellows Program at the University of Minnesota
- National Institute of Allergy and Infectious Diseases [K08AI134262, K23AI138851, T32AI055433]
- National Institute of Mental Health [K23MH121220]
- Fogarty International Center [D43TW009345]
- Lyonel G. Israels Professor of Hematology at the University of Manitoba
- Clinical Practice Assessment Unit of the McGill University Health Centre
- McGill Interdisciplinary Initiative in Infection and Immunity Emergency Covid-19 Research Funding Program
- Manitoba Medical Service Foundation
- Research Manitoba
- Northern Alberta Clinical Trials and Research Centre Covid-19 Clinical Research Grant
- National Institutes of Health National Center for Advancing Translational Sciences [UL1TR002494]
BackgroundCoronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are exposed, the standard of care is observation and quarantine. Whether hydroxychloroquine can prevent symptomatic infection after SARS-CoV-2 exposure is unknown. MethodsWe conducted a randomized, double-blind, placebo-controlled trial across the United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis. We enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Within 4 days after exposure, we randomly assigned participants to receive either placebo or hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days). The primary outcome was the incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days. ResultsWe enrolled 821 asymptomatic participants. Overall, 87.6% of the participants (719 of 821) reported a high-risk exposure to a confirmed Covid-19 contact. The incidence of new illness compatible with Covid-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]); the absolute difference was -2.4 percentage points (95% confidence interval, -7.0 to 2.2; P=0.35). Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported. ConclusionsAfter high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure. (Funded by David Baszucki and Jan Ellison Baszucki and others; ClinicalTrials.gov number, NCT04308668.) In this double-blind, randomized trial, 821 asymptomatic persons with a high-risk or moderate-risk exposure to SARS-CoV-2 were assigned to receive hydroxychloroquine or placebo within 4 days after the exposure. No benefit in preventing illness compatible with Covid-19 was found.
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