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

Iwein Gyselinck1, Laurens Liesenborghs2, Ann Belmans3

  • 1Dept of Respiratory Diseases, UZ Leuven and CHROMETA, Research group BREATHE, KU Leuven, Leuven, Belgium.

ERJ Open Research
|March 2, 2022
PubMed

Insights

Azithromycin did not improve clinical recovery in hospitalized COVID-19 patients. This study found no significant benefit of azithromycin for coronavirus disease 2019 patients during their hospital stay.

Area of Science:

  • Infectious Diseases
  • Clinical Trials
  • Pharmacology

Background:

  • Azithromycin was explored as a repurposed drug for coronavirus disease 2019 (COVID-19) early in the pandemic.
  • The efficacy of azithromycin in hospitalized patients with moderate to severe COVID-19 required clinical evaluation.

Purpose of the Study:

  • To evaluate the efficacy of azithromycin in patients hospitalized for COVID-19.
  • To determine if azithromycin accelerates clinical improvement in moderate to severe COVID-19 cases.

Main Methods:

  • A randomized, open-label, multicentre clinical trial (DAWn-AZITHRO) compared azithromycin plus standard of care versus standard of care alone.
  • The study involved 15 Belgian hospitals and focused on patients with moderate to severe COVID-19.
  • The primary outcome was time to live discharge or sustained clinical improvement using the WHO ordinal scale.

Main Results:

  • The trial was stopped early for futility following an interim analysis.
  • Azithromycin showed no significant effect on the primary outcome of time to clinical improvement (HR 1.044, p=0.7798).
  • No benefits were observed in secondary outcomes or predefined subgroups.

Conclusions:

  • Azithromycin does not influence the time to clinical improvement in hospitalized patients with moderate to severe COVID-19.
  • The repurposed use of azithromycin for COVID-19 did not demonstrate clinical benefit in this patient population.
Abstract

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