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

Publication ,  Journal Article
Cavalcanti, AB; Zampieri, FG; Rosa, RG; Azevedo, LCP; Veiga, VC; Avezum, A; Damiani, LP; Marcadenti, A; Kawano-Dourado, L; Lisboa, T; Milan, EP ...
Published in: N Engl J Med
November 19, 2020

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. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

November 19, 2020

Volume

383

Issue

21

Start / End Page

2041 / 2052

Location

United States

Related Subject Headings

  • Treatment Failure
  • SARS-CoV-2
  • Pneumonia, Viral
  • Patient Acuity
  • Pandemics
  • Middle Aged
  • Male
  • Hydroxychloroquine
  • Humans
  • Hospitalization
 

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Cavalcanti, A. B., Zampieri, F. G., Rosa, R. G., Azevedo, L. C. P., Veiga, V. C., Avezum, A., … Coalition Covid-19 Brazil I Investigators. (2020). Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19. N Engl J Med, 383(21), 2041–2052. https://doi.org/10.1056/NEJMoa2019014
Cavalcanti, Alexandre B., Fernando G. Zampieri, Regis G. Rosa, Luciano C. P. Azevedo, Viviane C. Veiga, Alvaro Avezum, Lucas P. Damiani, et al. “Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19.N Engl J Med 383, no. 21 (November 19, 2020): 2041–52. https://doi.org/10.1056/NEJMoa2019014.
Cavalcanti AB, Zampieri FG, Rosa RG, Azevedo LCP, Veiga VC, Avezum A, et al. Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19. N Engl J Med. 2020 Nov 19;383(21):2041–52.
Cavalcanti, Alexandre B., et al. “Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19.N Engl J Med, vol. 383, no. 21, Nov. 2020, pp. 2041–52. Pubmed, doi:10.1056/NEJMoa2019014.
Cavalcanti AB, Zampieri FG, Rosa RG, Azevedo LCP, Veiga VC, Avezum A, Damiani LP, Marcadenti A, Kawano-Dourado L, Lisboa T, Junqueira DLM, de Barros E Silva PGM, Tramujas L, Abreu-Silva EO, Laranjeira LN, Soares AT, Echenique LS, Pereira AJ, Freitas FGR, Gebara OCE, Dantas VCS, Furtado RHM, Milan EP, Golin NA, Cardoso FF, Maia IS, Hoffmann Filho CR, Kormann APM, Amazonas RB, Bocchi de Oliveira MF, Serpa-Neto A, Falavigna M, Lopes RD, Machado FR, Berwanger O, Coalition Covid-19 Brazil I Investigators. Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19. N Engl J Med. 2020 Nov 19;383(21):2041–2052.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

November 19, 2020

Volume

383

Issue

21

Start / End Page

2041 / 2052

Location

United States

Related Subject Headings

  • Treatment Failure
  • SARS-CoV-2
  • Pneumonia, Viral
  • Patient Acuity
  • Pandemics
  • Middle Aged
  • Male
  • Hydroxychloroquine
  • Humans
  • Hospitalization