巴西圣保罗HCor研究所Alexandre B. Cavalcanti团队研究了羟氯喹加或不加阿奇霉素治疗轻中度Covid-19的效果。2020年7月23日，《新英格兰医学杂志》发表了这一成果。

羟氯喹和阿奇霉素已被用于治疗Covid-19患者，但关于这些疗法安全性和有效性的数据很有限。

研究组进行了一项多中心、随机、开放标签、三组、对照试验，涉及住院的疑似或确诊Covid-19的患者，这些患者要么没有补充氧气，要么每分钟最多补充4升氧气。将患者按1：1：1随机分组，分别接受标准治疗（标准治疗组）、标准治疗+羟氯喹（羟氯喹组）、标准治疗+羟氯喹+阿奇霉素（羟氯喹+阿奇霉素组），连续7天。主要结局是改良意向治疗人群（Covid-19确诊患者）使用七级序贯量表（1-7，分数越高病情越差）来评估15天时的临床状态。

共有667例患者接受了随机分组，其中504例确诊为Covid-19，被纳入改良意向治疗分析。与标准治疗组相比，羟氯喹组或羟氯喹+阿奇霉素组治疗15天时，并未显著改善七级序贯量表得分。羟氯喹组或羟氯喹+阿奇霉素组中校正QT间期延长与肝酶水平升高的发生率均显著高于标准治疗组。

总之，与标准治疗相比，对于轻中度Covid-19住院患者，单独使用羟氯喹或联合阿奇霉素并不能改善15天时的临床状况。

附：英文原文

Title: Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19

Author: Alexandre B. Cavalcanti, M.D., Ph.D.,, Fernando G. Zampieri, M.D., Ph.D.,, Regis G. Rosa, M.D., Ph.D.,, Luciano C.P. Azevedo, M.D., Ph.D.,, Viviane C. Veiga, M.D., Ph.D.,, Alvaro Avezum, M.D., Ph.D.,, Lucas P. Damiani, M.Sc.,, Aline Marcadenti, Ph.D.,, Letícia Kawano-Dourado, M.D., Ph.D.,, Thiago Lisboa, M.D., Ph.D.,, Debora L. M. Junqueira, M.D.,, Pedro G.M. de Barros e Silva, M.D., Ph.D.,, Lucas Tramujas, M.D.,, Erlon O. Abreu-Silva, M.D.,, Ligia N. Laranjeira, Ph.D.,, Aline T. Soares, M.D., Ph.D.,, Leandro S. Echenique, M.D.,, Adriano J. Pereira, M.D., Ph.D.,, Flávio G.R. Freitas, M.D., Ph.D.,, Otávio C.E. Gebara, M.D., Ph.D.,, Vicente C.S. Dantas, M.D., Ph.D.,, Remo H.M. Furtado, M.D., Ph.D.,, Eveline P. Milan, M.D., Ph.D.,, Nicole A. Golin, M.D.,, Fábio F. Cardoso, M.D.,, Israel S. Maia, M.D.,, Conrado R. Hoffmann Filho, M.D.,, Adrian P.M. Kormann, M.D.,, Roberto B. Amazonas, M.D., Ph.D.,, Monalisa F. Bocchi de Oliveira, M.D.,, Ary Serpa-Neto, M.D., Ph.D.,, Maicon Falavigna, M.D., Ph.D.,, Renato D. Lopes, M.D., Ph.D.,, Flávia R. Machado, M.D., Ph.D.,, and Otavio Berwanger, M.D., Ph.D.

Issue&Volume: 2020-07-23

Abstract: BACKGROUND

Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited.

METHODS

We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed.

RESULTS

A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P=1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P=1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.

CONCLUSIONS

Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care.

DOI: 10.1056/NEJMoa2019014

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2019014