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Azithromycin versus standard care in patients with mild-to-moderate COVID-19 (ATOMIC2): an open-label, randomised trial

Hinks, Timothy S C, Cureton, Lucy, Knight, Ruth, Wang, Ariel, Cane, Jennifer L, Barber, Vicki S, Black, Joanna, Dutton, Susan J, Melhorn, James, Jabeen, Maisha, Moss, Phil, Garlapati, Rajendar, Baron, Tanya, Johnson, Graham, Cantle, Fleur, Clarke, David, Elkhodair, Samer, Underwood, Jonathan, Lasserson, Daniel, Pavord, Ian D, Morgan, Sophie and Richards, Duncan 2021. Azithromycin versus standard care in patients with mild-to-moderate COVID-19 (ATOMIC2): an open-label, randomised trial. The Lancet Respiratory Medicine 9 (10) , pp. 1130-1140. 10.1016/S2213-2600(21)00263-0

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Abstract

Background The antibacterial, anti-inflammatory, and antiviral properties of azithromycin suggest therapeutic potential against COVID-19. Randomised data in mild-to-moderate disease are not available. We assessed whether azithromycin is effective in reducing hospital admission in patients with mild-to-moderate COVID-19. Methods This prospective, open-label, randomised superiority trial was done at 19 hospitals in the UK. We enrolled adults aged at least 18 years presenting to hospitals with clinically diagnosed, highly probable or confirmed COVID-19 infection, with fewer than 14 days of symptoms, who were considered suitable for initial ambulatory management. Patients were randomly assigned (1:1) to azithromycin (500 mg once daily orally for 14 days) plus standard care or to standard care alone. The primary outcome was death or hospital admission from any cause over the 28 days from randomisation. The primary and safety outcomes were assessed according to the intention-to-treat principle. This trial is registered at ClinicalTrials.gov (NCT04381962) and recruitment is closed. Findings 298 participants were enrolled from June 3, 2020, to Jan 29, 2021. Three participants withdrew consent and requested removal of all data, and three further participants withdrew consent after randomisation, thus, the primary outcome was assessed in 292 participants (145 in the azithromycin group and 147 in the standard care group). The mean age of the participants was 45·9 years (SD 14·9). 15 (10%) participants in the azithromycin group and 17 (12%) in the standard care group were admitted to hospital or died during the study (adjusted OR 0·91 [95% CI 0·43–1·92], p=0·80). No serious adverse events were reported. Interpretation In patients with mild-to-moderate COVID-19 managed without hospital admission, adding azithromycin to standard care treatment did not reduce the risk of subsequent hospital admission or death. Our findings do not support the use of azithromycin in patients with mild-to-moderate COVID-19.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Additional Information: This is an Open Access article under the CC BY 4.0 license
Publisher: Elsevier
ISSN: 2213-2600
Date of First Compliant Deposit: 2 September 2021
Date of Acceptance: 1 July 2021
Last Modified: 21 Oct 2021 13:53
URI: https://orca.cardiff.ac.uk/id/eprint/143822

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