Efficacy of Tocilizumab for hospitalized patients with COVID-19 pneumonia and high IL-6 levels: A randomized controlled trial
Sellarès-Nadal, Júlia (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Espinosa-Pereiro, Juan (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Burgos, Joaquín (Universitat Autònoma de Barcelona. Departament de Medicina)
Falcó, Vicenç (Universitat Autònoma de Barcelona. Departament de Medicina)
Guillén-Del-Castillo, Alfredo (Hospital Universitari Vall d'Hebron)
Augustin Recio, Salvador (Centro de Investigación Biomédica en Red de Enfermedades Infecciosas)
Bañares-Sánchez, Joan (Hospital Universitari Vall d'Hebron)
Prio-Ruatg, Alba (Hospital Universitari Vall d'Hebron)
Martínez-Valle, Ferran (Hospital Universitari Vall d'Hebron)
Kirkegaard, Cristina (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Sánchez-Montalvá, Adrián (Hospital Universitari Vall d'Hebron. Institut de Recerca)

Data:	2025
Resum:	Background: The objective of this clinical trial is to evaluate the efficacy and safety of IL-6 driven personalized treatment strategy with tocilizumab in patients with severe COVID-19 pneumonia. Trial design: Randomized, controlled, open-label, single-center trial of a tocilizumab treatment strategy in adult patients hospitalized with severe COVID-19 pneumonia and IL-6 serum levels >40 pg/mL. Methods: Patients were randomized 1:1 to receive standard of care (SOC) or SOC plus one dose of tocilizumab. The primary outcome was death or need for invasive mechanical ventilation (IMV) within 28 days after randomization. Secondary outcomes included ICU admission, days on IMV and hospital stay. A meta-analysis of clinical trials to evaluate the effect of tocilizumab on mortality and need of IMV in patients with COVID-19 pneumonia was performed. Results: Sixty-two patients were included: 30 in the SOC arm and 32 in the standard-treatment plus tocilizumab arm. The primary outcome occurred in 12. 9% in the tocilizumab arm and 32. 3% in the SOC arm(p=0. 068). There was a trend towards fewer days on IMV (7. 5 vs 19. 5 days, p=0. 073) and a shorter hospital stay (4 vs 8 days, p=0. 134) in the tocilizumab group. No serious adverse events were reported. The meta-analysis revealed a RR for death or IMV of 0. 83 (95% CI: 0. 77- 0. 89) in patients receiving tocilizumab, compared to patients receiving SOC. Conclusion: Tocilizumab could be effective to prevent death or IMV in patients with severe COVID-19 pneumonia and high IL-6 serum levels. Safety profile of tocilizumab does not arise major concern in patients with severe COVID19.
Ajuts:	Instituto de Salud Carlos III PT17/0017/0030 Instituto de Salud Carlos III PT20/00078 Instituto de Salud Carlos III JR18/00022 Instituto de Salud Carlos III CM22/00262 Instituto de Salud Carlos III CM22/00246
Nota:	Altres ajuts: acords transformatius de la UAB
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Tocilizumab ; Interleukin-6 ; COVID-19 ; Viral pneumonia ; Acute Respiratory Distress Syndrome ; Randomized controlled trial
Publicat a:	Infection, 2025 , ISSN 1439-0973

DOI: 10.1007/s15010-025-02506-y
PMID: 40232661

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