A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19.
A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19.
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DOI：
10.1056/nejmoa2021801
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发表时间：
2021-02-04
期刊：
影响因子：
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通讯作者：
BCN-PEP-CoV2 Research Group
中科院分区：
文献类型：
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作者：
Mitjà O;Corbacho-Monné M;Ubals M;Alemany A;Suñer C;Tebé C;Tobias A;Peñafiel J;Ballana E;Pérez CA;Admella P;Riera-Martí N;Laporte P;Mitjà J;Clua M;Bertran L;Sarquella M;Gavilán S;Ara J;Argimon JM;Cuatrecasas G;Cañadas P;Elizalde-Torrent A;Fabregat R;Farré M;Forcada A;Flores-Mateo G;López C;Muntada E;Nadal N;Narejos S;Nieto A;Prat N;Puig J;Quiñones C;Ramírez-Viaplana F;Reyes-Urueña J;Riveira-Muñoz E;Ruiz L;Sanz S;Sentís A;Sierra A;Velasco C;Vivanco-Hidalgo RM;Zamora J;Casabona J;Vall-Mayans M;González-Beiras C;Clotet B;BCN-PEP-CoV2 Research Group
目前预防严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染的策略仅限于非药物干预。羟氯喹已被提议作为预防2019冠状病毒病（Covid-19）的暴露后疗法，但缺乏确切的证据。我们在西班牙加泰罗尼亚进行了一项开放标签、随机分组试验，涉及聚合酶链反应（PCR）确诊的新冠肺炎患者的无症状接触者。我们将接触者随机分配到羟氯喹组（一次服用800 mg，随后每天服用400 mg，持续6天）或常规护理组（未接受任何特定治疗）。主要结局是PCR证实的14天内有症状的Covid-19。次要结局是SARS-CoV-2感染，定义为与Covid-19相符的症状或PCR检测阳性，无论症状如何。对不良事件进行了长达28天的评估。该分析包括2020年3月17日至4月28日期间确定的672名新冠肺炎指示病例患者的2314名健康接触者。共有1116名接触者被随机分配接受羟氯喹治疗，1198名接受常规治疗。在PCR证实的症状性COVID-19发生率方面，羟氯喹组和常规治疗组的结果相似（分别为5.7%和6.2%;风险比为0.86 [95%置信区间为0.52至1.42]）。此外，与常规治疗相比，羟氯喹与SARS-CoV-2传播的发生率较低（分别为18.7%和17.8%）无关。羟氯喹组的不良事件发生率高于常规治疗组（56.1% vs. 5.9%），但未报告与治疗相关的严重不良事件。在接触PCR阳性病例患者的健康人中，使用羟氯喹的暴露后治疗不能预防SARS-CoV-2感染或症状性Covid-19。（由众筹活动YoMeCorono和其他人资助; BCN-PEP-CoV 2 ClinicalTrials.gov编号，NCT 04304053。
Current strategies for preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are limited to nonpharmacologic interventions. Hydroxychloroquine has been proposed as a postexposure therapy to prevent coronavirus disease 2019 (Covid-19), but definitive evidence is lacking. We conducted an open-label, cluster-randomized trial involving asymptomatic contacts of patients with polymerase-chain-reaction (PCR)–confirmed Covid-19 in Catalonia, Spain. We randomly assigned clusters of contacts to the hydroxychloroquine group (which received the drug at a dose of 800 mg once, followed by 400 mg daily for 6 days) or to the usual-care group (which received no specific therapy). The primary outcome was PCR-confirmed, symptomatic Covid-19 within 14 days. The secondary outcome was SARS-CoV-2 infection, defined by symptoms compatible with Covid-19 or a positive PCR test regardless of symptoms. Adverse events were assessed for up to 28 days. The analysis included 2314 healthy contacts of 672 index case patients with Covid-19 who were identified between March 17 and April 28, 2020. A total of 1116 contacts were randomly assigned to receive hydroxychloroquine and 1198 to receive usual care. Results were similar in the hydroxychloroquine and usual-care groups with respect to the incidence of PCR-confirmed, symptomatic Covid-19 (5.7% and 6.2%, respectively; risk ratio, 0.86 [95% confidence interval, 0.52 to 1.42]). In addition, hydroxychloroquine was not associated with a lower incidence of SARS-CoV-2 transmission than usual care (18.7% and 17.8%, respectively). The incidence of adverse events was higher in the hydroxychloroquine group than in the usual-care group (56.1% vs. 5.9%), but no treatment-related serious adverse events were reported. Postexposure therapy with hydroxychloroquine did not prevent SARS-CoV-2 infection or symptomatic Covid-19 in healthy persons exposed to a PCR-positive case patient. (Funded by the crowdfunding campaign YoMeCorono and others; BCN-PEP-CoV2 ClinicalTrials.gov number, NCT04304053.)