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 Gyselinck, Iwein
A1 Liesenborghs, Laurens
A1 Belmans, Ann
A1 Engelen, Matthias M.
A1 Betrains, Albrecht
A1 Van Thillo, Quentin
A1 Nguyen, Pham Anh Hong
A1 Goeminne, Pieter
A1 Soenen, Ann-Catherine
A1 De Maeyer, Nikolaas
A1 Pilette, Charles
A1 Papleux, Emmanuelle
A1 Vanderhelst, Eef
A1 Derweduwen, Aurélie
A1 Alexander, Patrick
A1 Bouckaert, Bernard
A1 Martinot, Jean-Benoît
A1 Decoster, Lynn
A1 Vandeurzen, Kurt
A1 Schildermans, Rob
A1 Verhamme, Peter
A1 Janssens, Wim
A1 Vos, Robin
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.