Sellarès-Nadal Júlia, Espinosa-Pereiro Juan, Burgos Joaquín, Falcó Vicenç, Guillén-Del-Castillo Alfredo, Augustin Salvador, Bañares-Sánchez Juan, Prio-Ruatg Alba, Martínez-Valle Ferran, Kirkegaard-Biosca Cristina, Sánchez-Montalvá Adrián
Department of Medicine, Universitat Autònoma de Barcelona, Bellaterra, Spain.
Infectious Diseases Department, Vall d'Hebron Barcelona Hospital Campus, Vall d'Hebron Hospital Universitari, Passeig Vall d'Hebrón 119-129, 08035, Barcelona, Spain.
Infection. 2025 Apr 15. doi: 10.1007/s15010-025-02506-y.
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.
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.
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.
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.
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.
本临床试验的目的是评估托珠单抗驱动的白细胞介素-6个性化治疗策略在重症新型冠状病毒肺炎患者中的疗效和安全性。
一项针对因重症新型冠状病毒肺炎住院且白细胞介素-6血清水平>40 pg/mL的成年患者的托珠单抗治疗策略的随机、对照、开放标签、单中心试验。
患者按1:1随机分组，分别接受标准治疗（SOC）或SOC加一剂托珠单抗。主要结局是随机分组后28天内死亡或需要有创机械通气（IMV）。次要结局包括入住重症监护病房（ICU）、接受IMV的天数和住院时间。对评估托珠单抗对新型冠状病毒肺炎患者死亡率和IMV需求影响的临床试验进行了荟萃分析。
纳入62例患者：SOC组30例，标准治疗加托珠单抗组32例。托珠单抗组主要结局发生率为12.9%，SOC组为32.3%（p = 0.068）。托珠单抗组接受IMV的天数有减少趋势（7.5天对19.5天，p = 0.073），住院时间有缩短趋势（4天对8天，p = 0.134）。未报告严重不良事件。荟萃分析显示，与接受SOC的患者相比，接受托珠单抗的患者死亡或IMV的相对危险度为0.83（95%置信区间：0.77 - 0.89）。
托珠单抗可能有效预防重症新型冠状病毒肺炎且白细胞介素-6血清水平高的患者死亡或IMV。托珠单抗的安全性在重症新型冠状病毒肺炎患者中未引起重大关注。
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