4.6 Article

Timely administration of tocilizumab improves outcome of hospitalized COVID-19 patients

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PLOS ONE
Volume 17, Issue 8, Pages -

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PUBLIC LIBRARY SCIENCE
DOI: 10.1371/journal.pone.0271807

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This study aimed to evaluate the efficacy of early tocilizumab treatment in hospitalized patients with COVID-19. The results showed that early use of tocilizumab in patients needing oxygen support can reduce mortality and the need for mechanical ventilation within 30 days. Additionally, the combination of tocilizumab and dexamethasone appears to enhance its efficacy.
Introduction The aim of this study was to determine the efficacy of early tocilizumab treatment for hospitalized patients with COVID-19 disease.Methods Open-label randomized phase II clinical trial investigating tocilizumab in patients with proven COVID-19 admitted to the general ward and in need of supplemental oxygen. The primary endpoint of the study was 30-day mortality with a prespecified 2-sided significance level of alpha = 0.10. A post-hoc analysis was performed for a combined endpoint of mechanical ventilation or death at 30 days. Secondary objectives included comparing the duration of hospital stay, ICU admittance and duration of ICU stay and the duration of mechanical ventilation.Results A total of 354 patients (67% men; median age 66 years) were enrolled of whom 88% received dexamethasone. Thirty-day mortality was 19% (95% CI 14%-26%) in the standard arm versus 12% (95% CI: 8%-18%) in the tocilizumab arm, hazard ratio (HR) = 0.62 (90% CI 0.39-0.98; p = 0.086). 17% of patients were admitted to the ICU in each arm (p = 0.89). The median stay in the ICU was 14 days (IQR 9-28) in the standard arm versus 9 days (IQR 5-14) in the tocilizumab arm (p = 0.014). Mechanical ventilation or death at thirty days was 31% (95% CI 24%-38%) in the standard arm versus 21% (95% CI 16%-28%) in the tocilizumab arm, HR = 0.65 (95% CI 0.42-0.98; p = 0.042).Conclusions This randomized phase II study supports efficacy for tocilizumab when given early in the disease course in hospitalized patients who need oxygen support, especially when concomitantly treated with dexamethasone.

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