Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19 Academic Article uri icon

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

authors

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

publication date

  • November 19, 2020

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