Hydroxychloroquine With or Without Azithromycin in Mild-to-Moderate Covid-19

Hydroxychloroquine ± Azithromycin in Mild to Moderate COVID-19

The New England Journal of Medicine

TAKE-HOME MESSAGE

• 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.

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.

The New England Journal of Medicine

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 

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Benjamin Hidalgo-Matlock
Skin Care Physicians of Costa Rica

Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574

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