TY - JOUR T1 - Azithromycin for treatment of hospitalised COVID-19 patients: a randomised, multicentre, open-label clinical trial (DAWn-AZITHRO) JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00610-2021 VL - 8 IS - 1 SP - 00610-2021 AU - Iwein Gyselinck AU - Laurens Liesenborghs AU - Ann Belmans AU - Matthias M. Engelen AU - Albrecht Betrains AU - Quentin Van Thillo AU - Pham Anh Hong Nguyen AU - Pieter Goeminne AU - Ann-Catherine Soenen AU - Nikolaas De Maeyer AU - Charles Pilette AU - Emmanuelle Papleux AU - Eef Vanderhelst AU - Aurélie Derweduwen AU - Patrick Alexander AU - Bernard Bouckaert AU - Jean-Benoît Martinot AU - Lynn Decoster AU - Kurt Vandeurzen AU - Rob Schildermans AU - Peter Verhamme AU - Wim Janssens AU - Robin Vos A2 - , Y1 - 2022/01/01 UR - http://openres.ersjournals.com/content/8/1/00610-2021.abstract N2 - 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.Previous randomised controlled studies with azithromycin in hospitalised COVID-19 patients assessed end-points at fixed timepoints. Complementary to this, DAWn-AZITHRO assessed time to sustained improvement. No benefit of azithromycin was shown. https://bit.ly/3FapyC7 ER -