Assessment of The Effect of Tocilizumab in Adult Hospitalized COVID-19 Pneumonia Patients: A Clinical Trial

Ahmad S, Salam MU, Patwary MI, Alam N, Taher MA, Ahmed MR, Goswami A, Jumma MA, Razzaque MF
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Abstract

ackground: Coronavirus disease 2019 (COVID-19) is a life-threatening infectious disease causing potentially severe acute respiratory infection which may lead to multi-organ dysfunction or failure due to severe acute respiratory syndrome coronavirus (SARS-CoV-2) also known as novel coronavirus (nCoV). Tocilizumab is anti-interleukin-6 receptor antibody may have potential role in minimizing mortality and mechanical ventilation requirements among hospitalized COVID-19 patients. Objective: To analyze the effect of tocilizumab in adult hospitalized COVID-19 pneumonia patients. Methods: This non-randomized, controlled, open-label trial was carried out at a tertiary care hospital, Sylhet, Bangladesh. Hospitalized COVID-19 pneumonia patients with hypoxia ( oxygen saturation < 92% on air or required oxygen) and proof of systemic inflammation(C-reactive protein ≥50mg/L) were assigned (in 1:1 ratio) to receive a standard care plus single dose of tocilizumab (8mg/kg up to a maximum of 800mg) or only standard care, who were not provided mechanical ventilation. Primary outcomes were 28-day mortality and necessity of mechanical ventilation. Results: The mean age was 59.08±12.39 years in tocilizumab group and mean age was 55.41±12.82 years in control group. Maximum patients were >60 years. The most common symptoms were fever (44.4%) then cough (38.9%), and others including diarrhoea, fatigue (33.3%). Majority risk factors were DM (47.7%) followed by HTN (30.5%). Mortality was more in control group than tocilizumab group which was 83.3% and 44.4% respectively. It is also observed that tocilizumab group patients needed mechanical ventilation significantly lower than the control group which was 19.4% and 44.4% respectively. The difference was statistically remarkable between the two groups (P<0.05). Conclusion: This study shows that hospitalized COVID-19 patients who were not receiving mechanical ventilation,tocilizumab increased survival rate and reduced the need of mechanical ventilation.
托珠单抗在成人住院COVID-19肺炎患者中的疗效评估:一项临床试验
背景:冠状病毒病2019 (COVID-19)是一种危及生命的传染病,可引起严重的急性呼吸道感染,严重急性呼吸综合征冠状病毒(SARS-CoV-2)也称为新型冠状病毒(nCoV),可能导致多器官功能障碍或衰竭。Tocilizumab是一种抗白细胞介素-6受体抗体,可能在降低住院COVID-19患者的死亡率和机械通气需求方面具有潜在作用。目的:分析托珠单抗在成人住院COVID-19肺炎患者中的疗效。方法:这项非随机、对照、开放标签的试验在孟加拉国Sylhet的一家三级保健医院进行。住院的COVID-19肺炎患者缺氧(空气氧饱和度< 92%或需要氧气)和全身炎症证明(c反应蛋白≥50mg/L)被分配(1:1比例)接受标准治疗加单剂量tocilizumab (8mg/kg至最大800mg)或仅接受标准治疗,不提供机械通气。主要结局为28天死亡率和机械通气的必要性。结果:托珠单抗组患者平均年龄59.08±12.39岁,对照组患者平均年龄55.41±12.82岁。最多患者>60岁。最常见的症状是发烧(44.4%),其次是咳嗽(38.9%),其他症状包括腹泻、疲劳(33.3%)。高危因素以DM(47.7%)居多,其次为HTN(30.5%)。对照组的死亡率高于托珠单抗组,分别为83.3%和44.4%。同时观察到托珠单抗组患者机械通气需求明显低于对照组,分别为19.4%和44.4%。两组比较差异有统计学意义(P<0.05)。结论:本研究显示,未接受机械通气的住院COVID-19患者,托珠单抗可提高生存率,减少机械通气需求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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