Efficacy of tocilizumab for hospitalized patients with COVID-19 pneumonia and high IL-6 levels: A randomized controlled trial.

IF 5.4 2区医学 Q1 INFECTIOUS DISEASES

Infection Pub Date : 2025-04-15 DOI:10.1007/s15010-025-02506-y

Júlia Sellarès-Nadal, Juan Espinosa-Pereiro, Joaquín Burgos, Vicenç Falcó, Alfredo Guillén-Del-Castillo, Salvador Augustin, Juan Bañares-Sánchez, Alba Prio-Ruatg, Ferran Martínez-Valle, Cristina Kirkegaard-Biosca, Adrián Sánchez-Montalvá

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引用次数: 0

Abstract

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.

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托珠单抗治疗住院COVID-19肺炎伴高IL-6的疗效：一项随机对照试验

背景：本临床试验的目的是评估IL-6驱动的个体化治疗策略联合托珠单抗在重症COVID-19肺炎患者中的疗效和安全性。试验设计：随机、对照、开放标签、单中心试验tocilizumab治疗COVID-19重症肺炎住院成人患者和血清IL-6水平> 40 pg/mL。方法：患者以1:1的比例随机分组，接受标准治疗（SOC）或SOC加一剂tocilizumab。主要结局为随机分组后28天内死亡或需要有创机械通气（IMV）。次要结局包括ICU入院、IMV治疗天数和住院时间。对临床试验进行荟萃分析，以评估托珠单抗对COVID-19肺炎患者死亡率和IMV需求的影响。结果：纳入62例患者：30例在SOC组，32例在标准治疗加托珠单抗组。tocilizumab组的主要结局发生率为12.9%，SOC组为32.3% （p = 0.068）。托珠单抗组IMV使用天数减少（7.5天vs 19.5天，p = 0.073），住院时间缩短（4天vs 8天，p = 0.134）。无严重不良事件报告。荟萃分析显示，与接受SOC的患者相比，接受tocilizumab的患者死亡或IMV的RR为0.83 （95% CI: 0.77-0.89）。结论：托珠单抗可有效预防血清IL-6水平高的COVID-19重症肺炎患者的死亡或IMV。托珠单抗的安全性在重症covid - 19患者中没有引起重大关注。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Infection 医学-传染病学

CiteScore

12.50

自引率

1.30%

发文量

224

审稿时长

6-12 weeks

期刊介绍： Infection is a journal dedicated to serving as a global forum for the presentation and discussion of clinically relevant information on infectious diseases. Its primary goal is to engage readers and contributors from various regions around the world in the exchange of knowledge about the etiology, pathogenesis, diagnosis, and treatment of infectious diseases, both in outpatient and inpatient settings. The journal covers a wide range of topics, including: Etiology: The study of the causes of infectious diseases. Pathogenesis: The process by which an infectious agent causes disease. Diagnosis: The methods and techniques used to identify infectious diseases. Treatment: The medical interventions and strategies employed to treat infectious diseases. Public Health: Issues of local, regional, or international significance related to infectious diseases, including prevention, control, and management strategies. Hospital Epidemiology: The study of the spread of infectious diseases within healthcare settings and the measures to prevent nosocomial infections. In addition to these, Infection also includes a specialized "Images" section, which focuses on high-quality visual content, such as images, photographs, and microscopic slides, accompanied by brief abstracts. This section is designed to highlight the clinical and diagnostic value of visual aids in the field of infectious diseases, as many conditions present with characteristic clinical signs that can be diagnosed through inspection, and imaging and microscopy are crucial for accurate diagnosis. The journal's comprehensive approach ensures that it remains a valuable resource for healthcare professionals and researchers in the field of infectious diseases.