A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19
A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19
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DOI：
10.1056/nejmoa2016638
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发表时间：
2020-08-06
影响因子：
158.5
通讯作者：
Hullsiek, Kathy H.
中科院分区：
文献类型：
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作者：
Boulware, David R.;Pullen, Matthew F.;Hullsiek, Kathy H.
背景2019冠状病毒病（Covid-19）是在暴露于严重急性呼吸综合征冠状病毒2（SARS-CoV-2）后发生的。对于接触者，护理标准是观察和隔离。羟氯喹是否可以预防症状感染后SARS-CoV-2 exposure is unknown.MethodsWe进行了一项随机，双盲，安慰剂对照试验，在美国和加拿大的部分地区测试羟氯喹作为postexplanation预防。我们招募了在家庭或职业中与确诊的新冠肺炎患者接触超过10分钟的成年人，这些人距离不到6英尺，既不戴口罩也不戴眼罩（高风险暴露），或者戴口罩但不戴眼罩（中等风险暴露）。在暴露后4天内，我们随机分配参与者接受安慰剂或羟氯喹（800 mg一次，随后在6至8小时内接受600 mg，然后每天600 mg，再持续4天）。主要结果是14天内实验室确诊的Covid-19或与Covid-19兼容的疾病的发生率。总体而言，87.6%的参与者（821人中的719人）报告了与确诊的Covid-19接触者的高风险接触。在接受羟氯喹治疗的受试者（414人中的49人[11.8%]）和接受安慰剂治疗的受试者（407人中的58人[14.3%]）之间，与COVID-19兼容的新疾病的发生率没有显著差异;绝对差异为-2.4个百分点（95%置信区间，-7.0至2.2; P=0.35）。与安慰剂相比，羟氯喹的副作用更常见（40.1% vs. 16.8%），但没有严重不良反应的报道。ConclusionsAfter high-risk or medium-risk exposure to Covid-19，羟氯喹不能预防与Covid-19相容的疾病或在暴露后4天内用作暴露后预防时确诊的感染。（由大卫巴斯祖基和扬埃里森巴斯祖基等人资助; ClinicalTrials.gov编号，NCT 04308668。）在这项双盲、随机试验中，821名有高风险或中等风险暴露于SARS-CoV-2的无症状患者被分配在暴露后4天内接受羟氯喹或安慰剂治疗。没有发现预防与COVID-19兼容的疾病的益处。
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.