COVID-19：罗氏Actemra在严重病例中未显示疗效：海外3期临床试验
新型冠状病毒肺炎（COVID-19）：新冠肺炎（COVID-19）：COVID-19：
瑞士罗氏公司：
7月29日，Chugai的抗体药物“ Actemra”宣布：“在临床试验中，我们无法达到主要终点。”
对于重症患者：
在欧洲和美国的研究中，没有发现有关肺部炎症或死亡率提高的重要数据。
“ Actemra”用作类风湿关节炎的治疗方法。
预期新型电晕对严重的肺炎“细胞因子风暴”的功效。
3期临床试验：
罗氏公司对450名重症住院患者进行了一项3期临床试验。
症状改善程度设定为主要评价项目：
与安慰剂相比，没有统计学上的显着差异。
死亡率与安慰剂组相似。
出院时间短于安慰剂组。
化学日报
https://www.chemicaldaily.co.jp/
Roche provides an update on the phase III COVACTA trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 associated pneumonia
COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality
The study is the first global, randomised, double-blind, placebo-controlled phase III trial investigating Actemra/RoActemra in this setting
Roche remains committed to continuing the Actemra/RoActemra clinical trial programme in COVID-19 to further explore
Actemra/RoActemra in other treatment settings, including in combination with an antiviral
Basel, 29 July – Roche (SIX: RO, ROG; OTCQX: RHHBY)
today announced that the phase III COVACTA study of Actemra®/RoActemra® (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia.
In addition, the key secondary endpoints, which included the difference in patient mortality at week four, were not met; however, there was a positive trend in time to hospital discharge in patients treated with Actemra/RoActemra.
The COVACTA study did not identify any new safety signals for Actemra/RoActemra.
Further analysis of the trial results is needed to fully understand the data. The results will be submitted for publication in a peer-reviewed journal.
“People around the world
are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week four.
We will continue to generate evidence to provide a more complete understanding of Actemra/RoActemra in COVID-19 associated pneumonia,” said
Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.
“We are grateful for the patients and physicians around the world who helped us to complete this study quickly during a public health crisis, while upholding the highest standards of scientific rigour. We will keep working to help combat the COVID-19 pandemic.”
The COVACTA trial
was conducted in collaboration with
the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services.