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Effect of Oral Azithromycin vs Placebo on COVID-19 Symptoms in Outpatients With SARS-CoV-2 Infection: A Randomized Clinical Trial.
JAMA. 2021 08 10; 326(6):490-498.JAMA

Abstract

Importance

Azithromycin has been hypothesized to have activity against SARS-CoV-2.

Objective

To 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 Participants

Randomized 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.

Interventions

Participants 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 Measures

The 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.

Results

Among 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 Relevance

Among 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 Registration

ClinicalTrials.gov Identifier: NCT04332107.

Authors+Show Affiliations

Francis I. Proctor Foundation, University of California, San Francisco. Department of Ophthalmology, University of California, San Francisco. Department of Epidemiology and Biostatistics, University of California, San Francisco.Department of Pathology, Stanford University School of Medicine, Stanford, California. Clinical Virology Laboratory, Stanford Health Care, Stanford, California. Division of Infectious Diseases and Geographic Medicine, Department of Medicine, Stanford School of Medicine, Stanford, California.Francis I. Proctor Foundation, University of California, San Francisco.Francis I. Proctor Foundation, University of California, San Francisco.Francis I. Proctor Foundation, University of California, San Francisco.Francis I. Proctor Foundation, University of California, San Francisco.Francis I. Proctor Foundation, University of California, San Francisco.Francis I. Proctor Foundation, University of California, San Francisco.Francis I. Proctor Foundation, University of California, San Francisco.Francis I. Proctor Foundation, University of California, San Francisco.Francis I. Proctor Foundation, University of California, San Francisco. Department of Ophthalmology, University of California, San Francisco.Francis I. Proctor Foundation, University of California, San Francisco. Department of Ophthalmology, University of California, San Francisco. Department of Epidemiology and Biostatistics, University of California, San Francisco.Francis I. Proctor Foundation, University of California, San Francisco. Department of Ophthalmology, University of California, San Francisco. Department of Epidemiology and Biostatistics, University of California, San Francisco.Francis I. Proctor Foundation, University of California, San Francisco. Department of Ophthalmology, University of California, San Francisco.Francis I. Proctor Foundation, University of California, San Francisco. Department of Ophthalmology, University of California, San Francisco.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

34269813

Citation

Oldenburg, Catherine E., et al. "Effect of Oral Azithromycin Vs Placebo On COVID-19 Symptoms in Outpatients With SARS-CoV-2 Infection: a Randomized Clinical Trial." JAMA, vol. 326, no. 6, 2021, pp. 490-498.
Oldenburg CE, Pinsky BA, Brogdon J, et al. Effect of Oral Azithromycin vs Placebo on COVID-19 Symptoms in Outpatients With SARS-CoV-2 Infection: A Randomized Clinical Trial. JAMA. 2021;326(6):490-498.
Oldenburg, C. E., Pinsky, B. A., Brogdon, J., Chen, C., Ruder, K., Zhong, L., Nyatigo, F., Cook, C. A., Hinterwirth, A., Lebas, E., Redd, T., Porco, T. C., Lietman, T. M., Arnold, B. F., & Doan, T. (2021). Effect of Oral Azithromycin vs Placebo on COVID-19 Symptoms in Outpatients With SARS-CoV-2 Infection: A Randomized Clinical Trial. JAMA, 326(6), 490-498. https://doi.org/10.1001/jama.2021.11517
Oldenburg CE, et al. Effect of Oral Azithromycin Vs Placebo On COVID-19 Symptoms in Outpatients With SARS-CoV-2 Infection: a Randomized Clinical Trial. JAMA. 2021 08 10;326(6):490-498. PubMed PMID: 34269813.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of Oral Azithromycin vs Placebo on COVID-19 Symptoms in Outpatients With SARS-CoV-2 Infection: A Randomized Clinical Trial. AU - Oldenburg,Catherine E, AU - Pinsky,Benjamin A, AU - Brogdon,Jessica, AU - Chen,Cindi, AU - Ruder,Kevin, AU - Zhong,Lina, AU - Nyatigo,Fanice, AU - Cook,Catherine A, AU - Hinterwirth,Armin, AU - Lebas,Elodie, AU - Redd,Travis, AU - Porco,Travis C, AU - Lietman,Thomas M, AU - Arnold,Benjamin F, AU - Doan,Thuy, PY - 2022/01/16/pmc-release PY - 2021/7/17/pubmed PY - 2021/8/17/medline PY - 2021/7/16/entrez SP - 490 EP - 498 JF - JAMA JO - JAMA VL - 326 IS - 6 N2 - Importance: Azithromycin has been hypothesized to have activity against SARS-CoV-2. Objective: To 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 Participants: Randomized 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. Interventions: Participants 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 Measures: The 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. Results: Among 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 Relevance: Among 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 Registration: ClinicalTrials.gov Identifier: NCT04332107. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/34269813/Effect_of_Oral_Azithromycin_vs_Placebo_on_COVID-19_Symptoms_in_Outpatients_With_SARS-CoV-2_Infection:_A_Randomized_Clinical_Trial. L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2021.11517 DB - PRIME DP - Unbound Medicine ER -