From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M., J.A., M.F., C.Q., M.V.-M., B.C.), IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute (E.B., A.E.-T., E.R.-M., L.R.), and the Center of Epidemiologic Studies of HIV/AIDS and STI of Catalonia, Catalan Institute of Oncology-Departament de Salut, Generalitat de Catalunya (E.M., J.R.-U., A. Sentis), Badalona, Facultat de Medicina-Universitat de Barcelona (M.C.-M., M.U.), Institute of Environmental Assessment and Water Research, Spanish Council for Scientific Research (A.T.), Direcció-Gerència, Institut Català de la Salut (J.M.A., J.C.), Equip d'Atenció Primària de Sarrià (G.C.), Synlab Diagnósticos (P.C.), Direcció General de Recerca i Innovació en Salut, Generalitat de Catalunya (R.F.), TFS Clinical Contract Research Organization (C.L., J.Z.), Gerència Territorial de Barcelona, Institut Català de la Salut (N.N.), ISGlobal, Hospital Clínic-Universitat de Barcelona (S.S.), and Agència de Qualitat i Avaluació Sanitàries de Catalunya (C.V., R.M.V.-H.), Barcelona, Bellvitge Biomedical Research Institute, L'Hospitalet de Llobregat (C.T., J. Peñafiel), Gerència Territorial de Catalunya Central, Institut Català de la Salut, Sant Fruitós de Bages (A.F.), Xarxa Santa Tecla Sanitària i Social, Tarragona (G.F.-M.), Entitat de Base Asociativa Centelles-Atenció Primària, Centelles (S.N.), Gerència Territorial de Àmbit Metropolità Nord, Institut Català de la Salut, Sabadell (N.P.), Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública, Madrid (J.C.), and Universitat de Vic-Universitat Central de Catalunya, Vic (O.M., B.C.) - all in Spain; and Lihir Medical Center-International SOS, Lihir Island, Papua New Guinea (O.M.).
N Engl J Med. 2021 Feb 4;384(5):417-427. doi: 10.1056/NEJMoa2021801. Epub 2020 Nov 24.
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.).
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一种暴露后治疗方法来预防 2019 年冠状病毒病（Covid-19），但缺乏确凿的证据。
我们在西班牙加泰罗尼亚地区进行了一项开放标签、集群随机试验，涉及聚合酶链反应（PCR）确诊的 Covid-19 患者的无症状接触者。我们将接触者集群随机分配到羟氯喹组（接受 800 毫克单次剂量，随后 6 天每天 400 毫克）或常规护理组（不接受特定治疗）。主要结局是 14 天内 PCR 确诊的有症状 Covid-19。次要结局是 SARS-CoV-2 感染，定义为符合 Covid-19 的症状或无论有无症状的阳性 PCR 检测结果。在 28 天内评估不良事件。
分析包括 2020 年 3 月 17 日至 4 月 28 日期间确定的 672 例 Covid-19 确诊指数病例的 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 名接受常规护理。在羟氯喹组和常规护理组中，PCR 确诊的有症状 Covid-19 的发生率相似（分别为 5.7%和 6.2%；风险比，0.86 [95%置信区间，0.52 至 1.42]）。此外，羟氯喹与常规护理相比，并不降低 SARS-CoV-2 的传播发生率（分别为 18.7%和 17.8%）。羟氯喹组的不良事件发生率高于常规护理组（56.1%比 5.9%），但没有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群中，暴露后用羟氯喹治疗不能预防 SARS-CoV-2 感染或有症状的 Covid-19。（由众筹活动 YoMeCorono 等资助；BCN-PEP-CoV2ClinicalTrials.gov 编号，NCT04304053。）
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