Azithromycin for treatment of hospitalised COVID-19 patients: a randomised, multicentre, open-label clinical trial (DAWn-AZITHRO)

DOI record: { "DOI": "10.1183/23120541.00610-2021", "ISSN": [ "2312-0541" ], "URL": "http://dx.doi.org/10.1183/23120541.00610-2021", "abstract": "<jats:sec>\n<jats:title>Background and objectives</jats:title>\n<jats:p>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.</jats:p>\n</jats:sec>\n<jats:sec>\n<jats:title>Methods</jats:title>\n<jats:p>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.</jats:p>\n</jats:sec>\n<jats:sec>\n<jats:title>Results</jats:title>\n<jats:p>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.</jats:p>\n</jats:sec>\n<jats:sec>\n<jats:title>Conclusion</jats:title>\n<jats:p>Time to clinical improvement is not influenced by azithromycin in patients hospitalised with moderate to severe COVID-19.</jats:p>\n</jats:sec>", "accepted": { "date-parts": [ [ 2021, 12, 28 ] ] }, "alternative-id": [ "10.1183/23120541.00610-2021" ], "author": [ { "ORCID": "https://orcid.org/0000-0002-4068-7228", "affiliation": [], "authenticated-orcid": false, "family": "Gyselinck", "given": "Iwein", "sequence": "first" }, { "affiliation": [], "family": "Liesenborghs", "given": "Laurens", "sequence": "additional" }, { "affiliation": [], "family": "Belmans", "given": "Ann", "sequence": "additional" }, { "affiliation": [], "family": "Engelen", "given": "Matthias M.", "sequence": "additional" }, { "affiliation": [], "family": "Betrains", "given": "Albrecht", "sequence": "additional" }, { "ORCID": 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