1. All-cause mortality at 28 days was similar between patients in the azithromycin group and usual care alone group.
2. There was no significant difference in the duration of hospital stay or the proportion of patients discharged alive at 28 days.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Corticosteroids are often used as primary treatment for COVID-19-induced respiratory illness. It is believed that macrolide antibiotics, such as azithromycin, clarithromycin, and erythromycin, may have similar immunomodulatory effects and offer therapeutic benefits. This multicenter, randomized controlled trial aimed to evaluate the safety and efficacy of azithromycin in patients admitted to the hospital with COVID-19. Primary outcome for this study was all-cause mortality at 28 days, while secondary outcomes included time to discharge from the hospital and invasive mechanical ventilation or death. According to study results, no significant difference was seen in the 28-day all-cause mortality rate, duration of hospital stay, and the proportion of patients discharged from hospital alive within 28 days. For patients not on invasive mechanical ventilation at baseline, no significant difference was seen in the proportion of participants requiring ventilation thereafter in both groups. This study was limited by a lack of longitudinal follow-up as clinical outcomes were only measured once, at 28 days. Long-term follow-up could have offered insight on any long-term effects of azithromycin in hospitalized patients. Nevertheless, this study provides valuable insight into the short-term use of azithromycin for treatment of patients hospitalized with COVID-19.
In-depth [randomized controlled trial]: Between Apr 7 and Nov 27, 2020, 16 442 patients were enrolled across 176 hospitals in the UK. Included patients were those with clinically suspected or laboratory confirmed SARS-CoV-2 infection and no known contraindications to azithromycin. Patients with prolonged QTc, hypersensitivity to a macrolide, and those already on chloroquine or hydroxychloroquine were excluded. Azithromycin was administered in 500 mg doses by mouth, nasogastric tube, or IV injection once a day for 10 days or until discharge. Altogether, 7763 patients (2582 in the azithromycin group and 5181 in the usual care group) were included in analysis. Among enrolled patients, the mean age was 65.3 years (standard deviation [SD] 15.7) and 62% (4819 of 7763) were men.
The primary outcome of all-cause mortality at 28 days was 22% in both groups (561 of 2582 patients in the azithromycin group vs. 1161 of 5181 patients in the usual care group, rate ratio [RR] 0.97, 95% confidence interval [CI] 0.87-1.07, p=0.50). Likewise, no significant difference was seen in the secondary outcomes assessing time until discharge from hospital alive (median 10 days, interquartile range [IQR] 5 to >28 for azithromycin vs. median 11 days, IQR 5 to >28 for usual care) and probability of discharge alive within 28 days (69% for azithromycin vs. 68% for usual care, RR 1.04, 95% CI 0.98-1.10, p=0.19). Among those not on invasive mechanical ventilation at baseline, the number of patients progressing to invasive mechanical ventilation or death was also similar in both treatment groups (25% for azithromycin vs. 26% for usual care, risk ratio 0.95, 95% CI 0.87-1.03, p=0.24). Overall, findings from this study show that azithromycin is not an effective treatment for patients hospitalized with COVID-19.
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