• Intensive care medicine · Nov 2021

    Randomized Controlled Trial Multicenter Study

    Tocilizumab and remdesivir in hospitalized patients with severe COVID-19 pneumonia: a randomized clinical trial.

    • Ivan O Rosas, George Diaz, Robert L Gottlieb, Suzana M Lobo, Philip Robinson, Bradley D Hunter, Adilson W Cavalcante, J Scott Overcash, Nicola A Hanania, Alan Skarbnik, Julia Garcia-Diaz, Ivan Gordeev, Jordi Carratalà, Oliver Gordon, Emily Graham, Nicholas Lewin-Koh, Larry Tsai, Katie Tuckwell, Huyen Cao, Diana Brainard, and Julie K Olsson.
    • Pulmonary, Critical Care, and Sleep Medicine, Lester and Sue Smith Chair in Lung Health, Baylor College of Medicine, 7200 Cambridge Street, Houston, TX, 77030, USA. ivan.rosas@bcm.edu.
    • Intensive Care Med. 2021 Nov 1; 47 (11): 125812701258-1270.

    PurposeTrials of tocilizumab in patients with severe COVID-19 pneumonia have demonstrated mixed results, and the role of tocilizumab in combination with other treatments is uncertain. Here we evaluated whether tocilizumab plus remdesivir provides greater benefit than remdesivir alone in patients with severe COVID-19 pneumonia.MethodsThis randomized, double-blind, placebo-controlled, multicenter trial included patients hospitalized with severe COVID-19 pneumonia requiring > 6 L/min supplemental oxygen. Patients were randomly assigned (2:1 ratio) to receive tocilizumab 8 mg/kg or placebo intravenously plus ≤ 10 days of remdesivir. The primary outcome was time from randomization to hospital discharge or "ready for discharge" (defined as category 1, assessed by the investigator on a 7-category ordinal scale of clinical status) to day 28. Patients were followed for 60 days.ResultsAmong 649 enrolled patients, 434 were randomly assigned to tocilizumab plus remdesivir and 215 to placebo plus remdesivir. 566 patients (88.2%) received corticosteroids during the trial to day 28. Median time from randomization to hospital discharge or "ready for discharge" was 14 (95% CI 12-15) days with tocilizumab plus remdesivir and 14 (95% CI 11-16) days with placebo plus remdesivir [log-rank P = 0.74; Cox proportional hazards ratio 0.97 (95% CI 0.78-1.19)]. Serious adverse events occurred in 128 (29.8%) tocilizumab plus remdesivir and 72 (33.8%) placebo plus remdesivir patients; 78 (18.2%) and 42 (19.7%) patients, respectively, died by day 28.ConclusionsTocilizumab plus remdesivir did not shorten time to hospital discharge or "ready for discharge" to day 28 compared with placebo plus remdesivir in patients with severe COVID-19 pneumonia.© 2021. The Author(s).

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