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Compared with standard of care, use of hydroxychloroquine with or without azithromycin did not improve clinical status at 15 days for patients with mild to moderate COVID-19 in this randomized open-label study.
Routine use of hydroxychloroquine with or without azithromycin is not supported in this setting.
– Neil Majithia, MD
This abstract is available on the publisher's site.
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.
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.
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.
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.
Hydroxychloroquine With or Without Azithromycin in Mild-to-Moderate Covid-19
N. Engl. J. Med 2020 Jul 23;[EPub Ahead of Print], AB Cavalcanti, FG Zampieri, RG Rosa, LCP Azevedo, VC Veiga, A Avezum, LP Damiani, A Marcadenti, L Kawano-Dourado, T Lisboa, DLM Junqueira, PGM de Barros e Silva, L Tramujas, EO Abreu-Silva, LN Laranjeira, AT Soares, LS Echenique, AJ Pereira, FGR Freitas, OCE Gebara, VCS Dantas, RHM Furtado, EP Milan, NA Golin, FF Cardoso, IS Maia, CR Hoffmann Filho, APM Kormann, RB Amazonas, MF Bocchi de Oliveira, A Serpa-Neto, M Falavigna, RD Lopes, FR Machado, O Berwanger