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

Abraham Rutgers*, Peter E Westerweel, Bronno van der Holt, Simone Postma, Marit G A van Vonderen, Djura P Piersma, Douwe Postma, Maarten van den Berge, Eefje Jong, Marten de Vries, Leonie van der Burg, Dennis Huugen, Marjolein van der Poel, Linda M Kampschreur, Marcel Nijland, Jaap H Strijbos, Menno Tamminga, Pim G N J Mutsaers, Suzanne Schol-Gelok, Margriet Dijkstra-TiekstraGrigory Sidorenkov, Julien Vincenten, Wouter H van Geffen, Marjolein Knoester, Jos Kosterink, Reinold Gans, Coen Stegeman, Gerwin Huls, Tom van Meerten

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


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 α = 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.

TRIAL REGISTRATION: https://www.trialregister.nl/trial/8504.

Original languageEnglish
Article numbere0271807
Number of pages13
Issue number8
Publication statusPublished - 12 Aug 2022


  • Aged
  • Antibodies, Monoclonal, Humanized
  • COVID-19/drug therapy
  • Dexamethasone/therapeutic use
  • Female
  • Humans
  • Male
  • Oxygen
  • Respiration, Artificial
  • SARS-CoV-2
  • Treatment Outcome

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