Azithromycin, again.
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lOral Azithromycin vs Placebo on COVID-19 Symptoms in Outpatients
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.
Reading the comments:
Cardiologist: "1) Why did these "researchers" use an endpoint of "self-reported symptoms"??? Why not hospitalizations, respiratory compromise, ICU cases or deaths? 2) Why not duration of illness symptoms? 3) And why a protocol of only 1 dose of Azithromycin? Why not a several day course of treatment?
Yes, this study was 50-50, no benefit. But they didn't use a real endpoint or a good treatment protocol. It is BS pseudo- science.. I am surprised it got published in a major journal."
Internist: "With only 76% of patients at 14 days follow up, 2/3 of patients randomized to the treatment group, your margin of error is nearly 70%. i.e. There would have to have been a preponderance in favor of no treatment for this to have been negative against treatment.
Another POS study. -
Why in the world would you think an antibacterial would affect a virus? And one dose versus the normal 5 day regimen? Pointless.
@mik said in Azithromycin, again.:
Why in the world would you think an antibacterial would affect a virus? And one dose versus the normal 5 day regimen? Pointless.
Superinfection (a bacterial infection on top of a viral pneumonitis) can be a problem.
