PT  - JOURNAL ARTICLE
AU  - Gyselinck, Iwein
AU  - Liesenborghs, Laurens
AU  - Belmans, Ann
AU  - Engelen, Matthias M.
AU  - Betrains, Albrecht
AU  - Van Thillo, Quentin
AU  - Nguyen, Pham Anh Hong
AU  - Goeminne, Pieter
AU  - Soenen, Ann-Catherine
AU  - De Maeyer, Nikolaas
AU  - Pilette, Charles
AU  - Papleux, Emmanuelle
AU  - Vanderhelst, Eef
AU  - Derweduwen, Aurélie
AU  - Alexander, Patrick
AU  - Bouckaert, Bernard
AU  - Martinot, Jean-Benoît
AU  - Decoster, Lynn
AU  - Vandeurzen, Kurt
AU  - Schildermans, Rob
AU  - Verhamme, Peter
AU  - Janssens, Wim
AU  - Vos, Robin
AU  - for the DAWn-AZITHRO investigators
TI  - Azithromycin for Treatment of Hospitalised COVID-19 Patients: a randomised, multicentre, open-label clinical trial (DAWn-AZITHRO)
AID  - 10.1183/23120541.00610-2021
DP  - 2022 Jan 01
TA  - ERJ Open Research
PG  - 00610-2021
4099  - http://openres.ersjournals.com/content/early/2022/01/06/23120541.00610-2021.short
4100  - http://openres.ersjournals.com/content/early/2022/01/06/23120541.00610-2021.full
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.