• Catherine E Oldenburg, Benjamin A Pinsky, Jessica Brogdon, Cindi Chen, Kevin Ruder, Lina Zhong, Fanice Nyatigo, Catherine A Cook, Armin Hinterwirth, Elodie Lebas, Travis Redd, Travis C Porco, Thomas M Lietman, Benjamin F Arnold, and Thuy Doan.
• Francis I. Proctor Foundation, University of California, San Francisco.
• JAMA. 2021 Aug 10; 326 (6): 490498490-498.

ImportanceAzithromycin has been hypothesized to have activity against SARS-CoV-2.ObjectiveTo determine whether oral azithromycin in outpatients with SARS-CoV-2 infection leads to absence of self-reported COVID-19 symptoms at day 14.Design, Setting, And ParticipantsRandomized clinical trial of azithromycin vs matching placebo conducted from May 2020 through March 2021. Outpatients from the US were enrolled remotely via internet-based surveys and followed up for 21 days. Eligible participants had a positive SARS-CoV-2 diagnostic test result (nucleic acid amplification or antigen) within 7 days prior to enrollment, were aged 18 years or older, and were not hospitalized at the time of enrollment. Among 604 individuals screened, 297 were ineligible, 44 refused participation, and 263 were enrolled. Participants, investigators, and study staff were masked to treatment randomization.InterventionsParticipants were randomized in a 2:1 fashion to a single oral 1.2-g dose of azithromycin (n = 171) or matching placebo (n = 92).Main Outcomes And MeasuresThe primary outcome was absence of self-reported COVID-19 symptoms at day 14. There were 23 secondary clinical end points, including all-cause hospitalization at day 21.ResultsAmong 263 participants who were randomized (median age, 43 years; 174 [66%] women; 57% non-Hispanic White and 29% Latinx/Hispanic), 76% completed the trial. The trial was terminated by the data and safety monitoring committee for futility after the interim analysis. At day 14, there was no significant difference in proportion of participants who were symptom free (azithromycin: 50%; placebo: 50%; prevalence difference, 0%; 95% CI, -14% to 15%; P > .99). Of 23 prespecified secondary clinical end points, 18 showed no significant difference. By day 21, 5 participants in the azithromycin group had been hospitalized compared with 0 in the placebo group (prevalence difference, 4%; 95% CI, -1% to 9%; P = .16).Conclusions And RelevanceAmong outpatients with SARS-CoV-2 infection, treatment with a single dose of azithromycin compared with placebo did not result in greater likelihood of being symptom free at day 14. These findings do not support the routine use of azithromycin for outpatient SARS-CoV-2 infection.Trial RegistrationClinicalTrials.gov Identifier: NCT04332107.

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