Department of Rheumatology and Clinical Immunology, University Medical Center Groningen, Groningen, The Netherlands.
Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands.
PLoS One. 2022 Aug 12;17(8):e0271807. doi: 10.1371/journal.pone.0271807. eCollection 2022.
The aim of this study was to determine the efficacy of early tocilizumab treatment for hospitalized patients with COVID-19 disease.
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.
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).
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.
本研究旨在确定早期托珠单抗治疗 COVID-19 住院患者的疗效。
这是一项开放标签、随机的 II 期临床试验，研究对象为因 COVID-19 住院且需要补充氧气的普通病房患者。该研究的主要终点为 30 天死亡率，预设双侧显著性水平α=0.10。对机械通气或 30 天死亡的联合终点进行了事后分析。次要目标包括比较住院时间、入住 ICU 时间、ICU 住院时间和机械通气时间。
共纳入 354 例患者（67%为男性；中位年龄 66 岁），其中 88%接受了地塞米松治疗。标准组 30 天死亡率为 19%（95%CI：14%-26%），托珠单抗组为 12%（95%CI：8%-18%），风险比（HR）为 0.62（95%CI：0.39-0.98；p=0.086）。两组各有 17%的患者入住 ICU（p=0.89）。标准组 ICU 中位住院时间为 14 天（IQR：9-28），托珠单抗组为 9 天（IQR：5-14）（p=0.014）。标准组机械通气或 30 天死亡为 31%（95%CI：24%-38%），托珠单抗组为 21%（95%CI：16%-28%），HR 为 0.65（95%CI：0.42-0.98；p=0.042）。
本随机 II 期研究支持在 COVID-19 住院患者需要氧疗时早期使用托珠单抗治疗，特别是与地塞米松联合使用时具有疗效。
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