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：

---

托珠单抗治疗重症 COVID-19 患者：SMAtteo COvid19 REgistry (SMACORE) 的初步结果。


目的：本研究旨在评估托珠单抗疗法（TCZ）对重症 COVID-19 肺炎危重症患者入住 ICU 和死亡率的作用。设计：COVID-19 肺炎患者前瞻性地纳入 SMatteo COvid19 REgistry (SMACORE)。使用倾向评分对接受 TCZ 治疗的患者与接受标准护理 (SOC) 治疗的患者进行了回顾性分析。地点：该研究于 2020 年 3 月 14 日至 27 日在意大利帕维亚的 IRCCS Policlinico San Matteo 医院进行。参与者：在 TCZ 可用时在我们机构住院的确诊为 COVID-19 的患者。干预措施：21 名患者接受了 TCZ 治疗。首次给药为 8 mg/kg（每剂最多 800 mg）托珠单抗静脉注射，如果首次给药后未报告副作用，则在 12 小时后重复给药。主要结果和措施：ICU 入住率和 7 天死亡率。次要结果包括临床和实验室数据。结果：共纳入112例患者（其中男性82例，女性30例，中位年龄63.55岁）。使用倾向评分，将接受 TCZ 的 21 名患者与接受 SOC（羟氯喹、阿奇霉素和预防剂量的低重量肝素的组合）的 21 名患者进行匹配。 TCZ 给药后未检测到不良事件。本研究发现，TCZ 治疗并未显着影响 ICU 入院（OR 0.11；95% CI 0.00 至 3.38 之间；p = 0.22）或 7 天死亡率（OR 0.78；95% CI 0.06 至 9.34 之间；p = 0.84 ）与 SOC 相比。 实验室测量分析显示，时间和治疗之间在 C 反应蛋白 (CRP)、丙氨酸转氨酶 (ALT)、血小板和国际标准化比值 (INR) 水平方面存在显着的相互作用。无论治疗如何，随时间观察淋巴细胞计数的变化。结论：在 21 名患者队列中，TCZ 给药并未降低 ICU 入住率或死亡率。需要更多数据来了解 TCZ 在治疗诊断为 COVID-19 的患者中的效果。