西班牙德国Trias i Pujol医院Oriol Mitjà团队研究了羟氯喹预防Covid-19的疗效。2020年11月24日，该研究发表在《新英格兰医学杂志》上。

当前预防SARS-CoV-2感染的策略仅限于非药物干预。有人提出将羟氯喹作为暴露后的治疗方法，以预防Covid-19，但缺乏确切的证据。

研究组在西班牙加泰罗尼亚进行了一项开放标签、集群随机试验，2020年3月17日至4月28日，研究组招募了672名经聚合酶链反应（PCR）确诊Covid-19患者的2314名无症状接触者。将其随机分组，其中1116名接受羟氯喹治疗，1198名接受常规护理。主要结局是14天内经PCR确诊的有症状Covid-19。次要结局为SARS-CoV-2感染。评估不良事件长达28天。

羟氯喹组中经PCR确诊的有症状Covid-19发生率为5.7%，常规护理组为6.2%，风险比为0.86。羟氯喹组SARS-CoV-2的传播率为17.8%，低于普通护理组（18.7%）。羟氯喹组的不良事件发生率为56.1％，显著高于常规护理（5.9％），但未发生与治疗相关的严重不良事件。

总之，对于Covid-19确诊患者的密切接触健康人群，用羟氯喹进行暴露后治疗不能预防SARS-CoV-2感染或有症状的Covid-19。

附：英文原文

Title: A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19

Author: Oriol Mitjà, Ph.D.,, Marc Corbacho-Monné, B.M.,, Maria Ubals, B.M.,, Andrea Alemany, B.M.,, Clara Suer, Ph.D.,, Cristian Tebé, Ph.D.,, Aurelio Tobias, Ph.D.,, Judith Peafiel, M.Sc.,, Ester Ballana, Ph.D.,, Carla A. Pérez, B.M.,, Pol Admella, B.M.,, Núria Riera-Martí, B.M.,, Pep Laporte, B.M.,, Jordi Mitjà, M.B.A.,, Mireia Clua, M.B.A.,, Laia Bertran, M.A.,, Maria Sarquella, M.A.,, Sergi Gavilán, B.A.,, Jordi Ara, Ph.D.,, Josep M. Argimon, Ph.D.,, Gabriel Cuatrecasas, B.M.,, Paz Caadas, Ph.D.,, Aleix Elizalde-Torrent, Ph.D.,, Robert Fabregat, Ph.D.,, Magí Farré, Ph.D.,, Anna Forcada, B.M.,, Gemma Flores-Mateo, Ph.D.,, Cristina López, B.Sc.,, Esteve Muntada, M.Sc.,, Núria Nadal, M.B.,, Silvia Narejos, B.M.,, Aroa Nieto, B.N.,, Nuria Prat, B.M.,, Jordi Puig, B.N.,, Carles Quiones, M.Pharm.,, Ferran Ramírez-Viaplana, M.Sc.,, Juliana Reyes-Uruea, Ph.D.,, Eva Riveira-Muoz, Ph.D.,, Lidia Ruiz, Ph.D.,, Sergi Sanz, Ph.D.,, Alexis Sentís, M.P.H.,, Alba Sierra, B.N.,, César Velasco, Ph.D.,, Rosa M. Vivanco-Hidalgo, Ph.D.,, Juani Zamora, B.Sc.,, Jordi Casabona, Ph.D.,, Martí Vall-Mayans, Ph.D.,, Camila González-Beiras, Ph.D.,, and Bonaventura Clotet, Ph.D.

Issue&Volume: 2020-11-24

Abstract:

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

DOI: 10.1056/NEJMoa2021801

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2021801