Ruxolitinib in severe COVID-19: Results of a multicenter, prospective, single arm, open-label clinical study to investigate the efficacy and safety of ruxolitinib in patients with COVID-19 and severe acute respiratory syndrome.
Ruxolitinib in severe COVID-19: Results of a multicenter, prospective, single arm, open-label clinical study to investigate the efficacy and safety of ruxolitinib in patients with COVID-19 and severe acute respiratory syndrome.
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ruxolitinib在严重的covid-19中：多中心，前瞻性，单臂，开放标签临床研究的结果，以研究鲁唑替尼在Covid-19和严重急性呼吸综合症患者中的疗效和安全性。
DOI：
10.31053/1853.0605.v78.n3.32800
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发表时间：
2021-09-07
期刊：
影响因子：
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通讯作者：
Caruso V
中科院分区：
文献类型：
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作者：
Iastrebner M;Castro J;García Espina E;Lettieri C;Payaslian S;Cuesta MC;Gutiérrez Fernández P;Mandrile A;Contreras AP;Gervasoni S;Verde G;Galetti C;Minoldo E;Caruso V
COVID-19死亡主要与严重急性呼吸综合征（SARS）的发展有关，这与宿主的免疫反应增强以及循环细胞因子升高有关。在这项前瞻性、多中心、单组（与历史对照相比）、添加、实验性II期研究中，将鲁索替尼5 mg BID添加至COVID-19患者的标准治疗中。主要目的是确定鲁索利替尼在COVID-19相关SARS患者中的疗效和安全性。尽管我们无法显示需要重症监护室住院和机械通气的COVID-19肺炎患者（主要终点）显著减少，但报告了接受鲁索利替尼治疗的危重患者死亡率降低的趋势。根据方案，32%的患者必须增加ruxolitinib给药剂量，无额外毒性。副作用特征可控，研究药物未引起直接器官损伤。Ruxolitinib具有快速抗炎作用，三分之一的患者在开始治疗后立即感觉良好。
COVID-19 morbimortality is mainly associated with development of severe acute respiratory syndrome (SARS), which has been related to an augmented immune response of the host with elevated circulating cytokines. In this prospective, multicenter, single arm (compared with a historical control), add-on, experimental phase 2 study, ruxolitinib 5 mg BID was added to standard of care in COVID-19 patients. Main objective was to determine efficacy and safety of ruxolitinib in patients with COVID-19-related SARS. Even though we could not show a significant reduction of COVID-19 pneumonia patients requiring intensive care unit admission and mechanical ventilation (primary endpoint), a trend to a lower mortality rate in critical ill patients receiving ruxolitinib was reported. Administered ruxolitinib dose had to be increased according to protocol in 32% of patients, without additional toxicity. Side effects profile was manageable, and no direct organ injury was caused by the study drug. Ruxolitinib had a fast anti-inflammatory effect, and one-third of patients felt well immediately after starting treatment.