Objective: This study aimed to assess the role of Tocilizumab therapy (TCZ) in terms of ICU admission and mortality rate of critically ill patients with severe COVID-19 pneumonia. Design: Patients with COVID-19 pneumonia were prospectively enrolled in SMAtteo COvid19 REgistry (SMACORE). A retrospective analysis of patients treated with TCZ matched using propensity score to patients treated with Standard Of Care (SOC) was conducted. Setting: The study was conducted at IRCCS Policlinico San Matteo Hospital, Pavia, Italy, from March 14, 2020 to March 27, 2020. Participants: Patients with a confirmed diagnosis of COVID-19 hospitalized in our institution at the time of TCZ availability. Interventions: TCZ was administered to 21 patients. The first administration was 8 mg/kg (up to a maximum 800 mg per dose) of Tocilizumab intravenously, repeated after 12 h if no side effects were reported after the first dose. Main Outcomes and Measures: ICU admission and 7-day mortality rate. Secondary outcomes included clinical and laboratory data. Results: There were 112 patients evaluated (82 were male and 30 were female, with a median age of 63.55 years). Using propensity scores, the 21 patients who received TCZ were matched to 21 patients who received SOC (a combination of hydroxychloroquine, azithromycin and prophylactic dose of low weight heparin). No adverse event was detected following TCZ administration. This study found that treatment with TCZ did not significantly affect ICU admission (OR 0.11; 95% CI between 0.00 and 3.38; p = 0.22) or 7-day mortality rate (OR 0.78; 95% CI between 0.06 and 9.34; p = 0.84) when compared with SOC. Analysis of laboratory measures showed significant interactions between time and treatment regarding C-Reactive Protein (CRP), alanine aminotransferase (ALT), platelets and international normalized ratio (INR) levels. Variation in lymphocytes count was observed over time, irrespective of treatment. Conclusions: TCZ administration did not reduce ICU admission or mortality rate in a cohort of 21 patients. Additional data are needed to understand the effect(s) of TCZ in treating patients diagnosed with COVID-19.

中文翻译：

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托珠单抗用于治疗COVID-19重症患者：SMAtteo COvid19 REgistry（SMACORE）的初步结果。

目的：本研究旨在评估Tocilizumab治疗（TCZ）在重症患者COVID-19重症肺炎的ICU入院率和死亡率方面的作用。设计：COVID-19肺炎患者前瞻性纳入SMAtteo COvid19 REgistry（SMACORE）。进行回顾性分析，以倾向得分匹配的TCZ治疗患者与以标准护理（SOC）治疗的患者进行回顾性分析。地点：该研究于2020年3月14日至2020年3月27日在意大利帕维亚的IRCCS Policlinico San Matteo医院进行。参加者：在获得TCZ时，确诊为COVID-19的患者已住院。干预措施：TCZ给予21例患者。第一次给药是静脉注射To​​cilizumab 8 mg / kg（每剂最多800 mg），如果在第一剂后没有副作用报告，则在12小时后重复进行。主要结果和措施：入住ICU和7天死亡率。次要结果包括临床和实验室数据。结果：共评估了112例患者（男性82例，女性30例，中位年龄为63.55岁）。使用倾向评分，将21位接受TC​​Z的患者与21位接受SOC（羟氯喹，阿奇霉素和低剂量肝素的预防剂量的组合）的患者相匹配。TCZ给药后未检测到不良事件。这项研究发现，使用TCZ的治疗不会显着影响ICU的住院率（OR 0.11； 95％CI在0.00和3.38之间； p = 0.22）或7天死亡率（OR 0.78； 95％CI在0.06和9.34之间； p = 0.84 ）与SOC相比。实验室指标分析显示，时间与治疗之间存在显着的相互作用，涉及C反应蛋白（CRP），丙氨酸转氨酶（ALT），血小板和国际标准化比率（INR）水平。观察淋巴细胞计数随时间的变化，与治疗无关。结论：TCZ的使用并未降低21名患者的ICU入院率或死亡率。需要其他数据来了解TCZ在治疗诊断为COVID-19的患者中的作用。TCZ给药未降低21名患者的ICU入院率或死亡率。需要其他数据来了解TCZ在治疗诊断为COVID-19的患者中的作用。TCZ给药未降低21名患者的ICU入院率或死亡率。需要其他数据来了解TCZ在治疗诊断为COVID-19的患者中的作用。