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Azithromycin doesn't reduce hospitalisation or mortality risk in mild-to-moderate COVID-19

A randomised clinical trial conducted in the United Kingdom found that use of the antibiotic azithromycin in patients with mild-to-moderate COVID-19 did not reduce the risk of subsequent hospital admission or death, reports MedicalBrief.

The results were presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) and published simultaneously in The Lancet Respiratory Medicine.

The open-label, randomised trial conducted at 19 UK hospitals from 3 June 2020, to 29 January 2021, adult COVID-19 patients considered suitable for initial ambulatory management were assigned to receive either standard care plus 500 milligrams of azithromycin once a day for 14 days or standard care alone. The primary outcome was hospital admission or death from any cause within 28 days of randomisation.

A total of 298 patients was enrolled, and the primary outcome was assessed in 292. The mean age of patients 45,9 years. Fifteen of 145 patients (10%) randomly assigned to azithromycin were admitted to hospital or died, compared with 17 of 147 (12%) who received standard care alone, for an adjusted odds ratio of 0.91 (95% confidence interval [CI], 0.43 to 1.92). Unadjusted and fully adjusted analyses (further adjusted for age, chronic pulmonary disease, and presence of cancer) demonstrated no significant differences between treatment groups.

This is the latest clinical trial to find no benefit for azithromycin in treating COVID-19 patients, either alone or combined with the antimalaria drug hydroxychloroquine. The previous trials have mainly involved hospitalised patients with late-stage, severe disease, or patients in the early stages of disease with minimal symptoms, while this study focused on patients in the early stages of disease who were at high risk for deterioration.

Another distinction of the study was that patients received a high dose of azithromycin for a long duration, so that antiviral, antibacterial, and anti-inflammatory benefits could be assessed.

"In conclusion, our findings in mild-to-moderate COVID-19 managed in ambulatory care, taken with trials in early disease in primary care and from trials in patients admitted to hospital with severe disease, suggest that azithromycin does not reduce hospital admissions, respiratory failure, or death compared with standard care, and should not be used in the treatment of COVID-19," the study authors wrote.

Study details

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

Timothy S C Hinks, Lucy Cureton, Ruth Knight, Ariel Wang, Jennifer L Cane, Vicki S Barber, Joanna Black, Susan J Dutton, James Melhorn, Maisha Jabeen, Phil Moss, Rajendar Garlapati, Tanya Baron, Graham Johnson, Fleur Cantle, David Clarke, Samer Elkhodair, Jonathan Underwood, Daniel Lasserson, Prof Ian D Pavord, Sophie Morgan, Prof Duncan Richards

Published in The Lancet 9 July 2021

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 (500mg 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

Findings
A total of 298 participants were enrolled from 3 June 2020, to 29 January 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.

 

The Lancet article – Azithromycin versus standard care in patients with mild-to-moderate COVID-19 (ATOMIC2): an open-label, randomised trial (Open access)

 

See more from MedicalBrief archives:

 

Azithromycin doesn't reduce recovery time or hospitalisation risk — PRINCIPLE trial

 

Azithromycin in combination may increase risk for cardiac events

 

Hydroxychloroquine plus azithromycin doubles cardiovascular mortality risk

 

Safety of chloroquine, hydroxychloroquine and azithromycin for treating COVID-19

 

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