Abstract
SummaryBackgroundThe 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.MethodsThis 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.Findings298 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.InterpretationIn 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.FundingNational Institute for Health Research Oxford Biomedical Research Centre, University of Oxford and Pfizer.
Highlights
Azithromycin is an orally active synthetic macrolide antibiotic with a wide range of antibacterial, anti-inflam matory, and antiviral properties.[1]
Enrolment was based on a clinical diagnosis of highly probable COVID-19, but the definitive results of nasop haryngeal swabs for SARS-CoV-2 PCR were available from 231 individuals, of which 152 (66%) were positive, and constituted the ITT positive population (76 azithrom ycin and 76 standard care). 143 (97%) of 147 participants allocated to azithromycin commenced treatment, with 76 (52%) achieving full compliance, 51 (35%) non-compliant, taking a median 6 tablets (IQR 2–17), and compliance was unknown in 20 (14%; appendix p 23)
Three (2%) of 145 participants randomly assigned to azithromycin and four (3%) of 147 participants randomly assigned to standard care reported a complication during hospital stay. In this trial of people with clinically diagnosed mild-tomoderate COVID-19 managed without hospital admis sion, adding azithromycin to standard care treatment did not reduce the risk of subsequent hospital admission or death, or of time to hospital admission
Summary
Azithromycin is an orally active synthetic macrolide antibiotic with a wide range of antibacterial, anti-inflam matory, and antiviral properties.[1] Early in 2020 it was highlighted by in silico and in vitro[2] screens as a potential candidate therapy to be repurposed for treatment of COVID-19. Macrolides, azithromycin, have previously been used to treat other viral infections, including one in three severe cases of MERS-CoV,[3] randomised controlled trial data for its use in any coronavirus disease were absent.[4] Azithromycin is inexpensive, safe, and widely available, and—stimulated by a small, non-randomised clinical report5—its use in the context of COVID-19 has become widespread in clinical practice and clinical trials. We assessed whether azithromycin is effective in reducing hospital admission in patients with mild-to-moderate COVID-19
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