RT Journal Article SR Electronic T1 Azithromycin for Treatment of Hospitalised COVID-19 Patients: a randomised, multicentre, open-label clinical trial (DAWn-AZITHRO) JF ERJ Open Research JO erjor FD European Respiratory Society SP 00610-2021 DO 10.1183/23120541.00610-2021 A1 Iwein Gyselinck A1 Laurens Liesenborghs A1 Ann Belmans A1 Matthias M. Engelen A1 Albrecht Betrains A1 Quentin Van Thillo A1 Pham Anh Hong Nguyen A1 Pieter Goeminne A1 Ann-Catherine Soenen A1 Nikolaas De Maeyer A1 Charles Pilette A1 Emmanuelle Papleux A1 Eef Vanderhelst A1 Aurélie Derweduwen A1 Patrick Alexander A1 Bernard Bouckaert A1 Jean-Benoît Martinot A1 Lynn Decoster A1 Kurt Vandeurzen A1 Rob Schildermans A1 Peter Verhamme A1 Wim Janssens A1 Robin Vos A1 for the DAWn-AZITHRO investigators YR 2022 UL http://openres.ersjournals.com/content/early/2022/01/06/23120541.00610-2021.abstract AB Background and objectives Azithromycin was rapidly adopted as a repurposed drug to treat 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, multicenter 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 patients 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 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 Hazard ratio of 1.044 (95% confidence interval, 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.