ERJ Open Research (Feb 2022)

Azithromycin for treatment of hospitalised COVID-19 patients: a randomised, multicentre, open-label clinical trial (DAWn-AZITHRO)

  • Iwein Gyselinck,
  • Laurens Liesenborghs,
  • Ann Belmans,
  • Matthias M. Engelen,
  • Albrecht Betrains,
  • Quentin Van Thillo,
  • Pham Anh Hong Nguyen,
  • Pieter Goeminne,
  • Ann-Catherine Soenen,
  • Nikolaas De Maeyer,
  • Charles Pilette,
  • Emmanuelle Papleux,
  • Eef Vanderhelst,
  • Aurélie Derweduwen,
  • Patrick Alexander,
  • Bernard Bouckaert,
  • Jean-Benoît Martinot,
  • Lynn Decoster,
  • Kurt Vandeurzen,
  • Rob Schildermans,
  • Peter Verhamme,
  • Wim Janssens,
  • Robin Vos

DOI
https://doi.org/10.1183/23120541.00610-2021
Journal volume & issue
Vol. 8, no. 1

Abstract

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Background and objectives Azithromycin was rapidly adopted as a repurposed drug to treat coronavirus disease 2019 (COVID-19) early in the pandemic. We aimed to evaluate its efficacy in patients hospitalised for COVID-19. Methods In a series of randomised, open-label, phase 2 proof-of-concept, multicentre clinical trials (Direct Antivirals Working against the novel coronavirus (DAWn)), several treatments were compared with standard of care. In 15 Belgian hospitals, patients hospitalised with moderate to severe COVID-19 were allocated 2:1 to receive standard of care plus azithromycin or standard of care alone. The primary outcome was time to live discharge or sustained clinical improvement, defined as a two-point improvement on the World Health Organization (WHO) ordinal scale sustained for at least 3 days. Results Patients were included between April 22 and December 17, 2020. When 15-day follow-up data were available for 160 patients (56% of preset cohort), an interim analysis was performed at request of the independent Data Safety and Monitoring Board. Subsequently, DAWn-AZITHRO was stopped for futility. In total, 121 patients were allocated to the treatment arm and 64 patients to the standard-of-care arm. We found no effect of azithromycin on the primary outcome with a hazard ratio of 1.044 (95% CI 0.772–1.413; p=0.7798). None of the predefined subgroups showed significant interaction as covariates in the Fine–Gray regression analysis. No benefit of azithromycin was found on any of the short- and longer-term secondary outcomes. Conclusion Time to clinical improvement is not influenced by azithromycin in patients hospitalised with moderate to severe COVID-19.