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April 22, 2021 VOL. 384 NO. 16 1503-1516

Tocilizumab in Hospitalized Patients with Severe Covid-19 Pneumonia

By Ivan Rosas
From Baylor College of Medicine, Houston, Texas.

Covid-19 is associated with immune dysregulation and hyperinflammation, including elevated interleukin-6 levels. The use of tocilizumab, a monoclonal antibody against the interleukin-6 receptor, has resulted in better outcomes in patients with severe Covid-19 pneumonia in case reports and retrospective observational cohort studies. In this phase 3 trial, 438 patients who were hospitalized with severe Covid-19 pneumonia were randomly assigned in a 2:1 ratio to receive a single intravenous infusion of tocilizumab or placebo. Approximately one quarter of the participants received a second dose of tocilizumab or placebo 8 to 24 hours after the first dose. The primary outcome was clinical status at day 28 on an ordinal scale ranging from 1 (discharged or ready for discharge) to 7 (death) in the modified intention-to-treat population. The median value for clinical status on the ordinal scale at day 28 was 1.0 in the tocilizumab group and 2.0 (non-ICU hospitalization without supplemental oxygen) in the placebo group. In the safety population, serious adverse events occurred in 34.9% of patients in the tocilizumab group and in 38.5% of patients in the placebo group. Mortality at day 28 was 19.7% in the tocilizumab group and 19.4% in the placebo group. In this randomized trial involving hospitalized patients with severe Covid-19 pneumonia, the use of tocilizumab did not result in significantly better clinical status or lower mortality than placebo at 28 days.

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