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

作者：Alexandre Biasi Cavalcanti, Fernando G Zampieri, Régis Goulart Rosa, Luciano César Pontes Azevedo, Viviane Cordeiro Veiga, Álvaro Avezum, Lucas Petri Damiani, Aline Marcadenti, Leticia Barbosa Kawano-Dourado, Thiago Costa Lisboa, Débora Junqueira, Pedro Gabriel Melo de Barros e Silva, Lucas Tramujas, Erlon Oliveira de Abreu-Silva, Lígia Nasi Laranjeira, Aline Thomaz Soares, Leandro Santini Echenique, Adriano José Pereira, Flávio Geraldo Rezende Freitas, Otávio Gebara, Vicente C S Dantas, Remo H.M. Furtado, Eveline Pı́polo Milan, Nicole Alberti Golin, Fábio Florença Cardoso, Israel Silva Maia, Conrado Roberto Hoffmann Filho, Adrian Kormann, Roberto Bleuel Amazonas, Monalisa Fernanda Bocchi de Oliveira, Ary Serpa Neto, Maicon Falavigna, Renato D. Lópes, F.S. Machado, Otavio B Berwanger · 发表于：New England Journal of Medicine · 年份：2020 · DOI：10.1056/nejmoa2019014 · 被引用次数：1128 · 研究领域：COVID-19 Clinical Research Studies、Pharmacological Receptor Mechanisms and Effects、Long-Term Effects of COVID-19

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 azi...