tetano
Editor, Senior Moderator
ERJ Open Res
. 2022 Feb 28;8(1):00610-2021.
doi: 10.1183/23120541.00610-2021. eCollection 2022 Jan.
Azithromycin for treatment of hospitalised COVID-19 patients: a randomised, multicentre, open-label clinical trial (DAWn-AZITHRO)
Iwein Gyselinck[SUP] 1 [/SUP], Laurens Liesenborghs[SUP] 2 [/SUP], Ann Belmans[SUP] 3 [/SUP], Matthias M Engelen[SUP] 4 [/SUP], Albrecht Betrains[SUP] 5 6 [/SUP], Quentin Van Thillo[SUP] 7 8 [/SUP], Pham Anh Hong Nguyen[SUP] 9 [/SUP], Pieter Goeminne[SUP] 10 [/SUP], Ann-Catherine Soenen[SUP] 11 [/SUP], Nikolaas De Maeyer[SUP] 12 [/SUP], Charles Pilette[SUP] 13 [/SUP], Emmanuelle Papleux[SUP] 14 [/SUP], Eef Vanderhelst[SUP] 15 [/SUP], Aurélie Derweduwen[SUP] 16 [/SUP], Patrick Alexander[SUP] 17 [/SUP], Bernard Bouckaert[SUP] 18 [/SUP], Jean-Benoît Martinot[SUP] 19 [/SUP], Lynn Decoster[SUP] 20 [/SUP], Kurt Vandeurzen[SUP] 21 [/SUP], Rob Schildermans[SUP] 22 [/SUP], Peter Verhamme[SUP] 4 [/SUP], Wim Janssens[SUP] 1 [/SUP], Robin Vos[SUP] 1 [/SUP]
Affiliations
Abstract
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.
. 2022 Feb 28;8(1):00610-2021.
doi: 10.1183/23120541.00610-2021. eCollection 2022 Jan.
Azithromycin for treatment of hospitalised COVID-19 patients: a randomised, multicentre, open-label clinical trial (DAWn-AZITHRO)
Iwein Gyselinck[SUP] 1 [/SUP], Laurens Liesenborghs[SUP] 2 [/SUP], Ann Belmans[SUP] 3 [/SUP], Matthias M Engelen[SUP] 4 [/SUP], Albrecht Betrains[SUP] 5 6 [/SUP], Quentin Van Thillo[SUP] 7 8 [/SUP], Pham Anh Hong Nguyen[SUP] 9 [/SUP], Pieter Goeminne[SUP] 10 [/SUP], Ann-Catherine Soenen[SUP] 11 [/SUP], Nikolaas De Maeyer[SUP] 12 [/SUP], Charles Pilette[SUP] 13 [/SUP], Emmanuelle Papleux[SUP] 14 [/SUP], Eef Vanderhelst[SUP] 15 [/SUP], Aurélie Derweduwen[SUP] 16 [/SUP], Patrick Alexander[SUP] 17 [/SUP], Bernard Bouckaert[SUP] 18 [/SUP], Jean-Benoît Martinot[SUP] 19 [/SUP], Lynn Decoster[SUP] 20 [/SUP], Kurt Vandeurzen[SUP] 21 [/SUP], Rob Schildermans[SUP] 22 [/SUP], Peter Verhamme[SUP] 4 [/SUP], Wim Janssens[SUP] 1 [/SUP], Robin Vos[SUP] 1 [/SUP]
Affiliations
- PMID: 35233389
- PMCID: PMC8801156
- DOI: 10.1183/23120541.00610-2021
Abstract
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.