《Nature,2月25日,Trends in COVID-19 therapeutic clinical trials》

  • 来源专题:COVID-19科研动态监测
  • 编译者: zhangmin
  • 发布时间:2021-03-01
  • The COVID-19 pandemic has stimulated intense efforts to find effective therapeutics for all stages of the disease. Unfortunately, the scope, scientific rigour and clinical value of research activities undertaken worldwide have been difficult to gauge, especially amid the rapidly evolving landscape. From the very beginning of the search for effective preventive and therapeutic agents, the US Food and Drug Administration (FDA) has been committed to helping to identify and develop evidence-based therapeutics through well-designed clinical trials. It is critically important to protect patients from inefficacious or unsafe drugs while advancing those evidence-based efforts efficiently — without duplication or otherwise wasting resources — to bring effective interventions to patients. To inform such efforts, the FDA has sought a comprehensive understanding of the global COVID-19 clinical trials landscape. Here, we present our assessment of ongoing COVID-19 therapeutic clinical development efforts worldwide.

  • 原文来源:https://www.nature.com/articles/d41573-021-00037-3
相关报告
  • 《2月25日_COVID-19治疗性临床试验的趋势》

    • 来源专题:COVID-19科研动态监测
    • 编译者:zhangmin
    • 发布时间:2021-03-01
    • 美国食品药品监理局的研究人员2月25日在Nature上发表了“Trends in COVID-19 therapeutic clinical trials”的综述。 2020年,COVID-19治疗性临床试验的数量一直在稳定增长,3月有443个试验组开始,直到10月为止,每个月都增加约29%。3月份,大多数试验组是抗病毒药(31%)或免疫调节剂(31%),其次是联合试验(17%)。到十月,抗病毒药物(17%)和免疫调节剂(26%)的份额减少,而中和抗体(9%)和其他抗体(29%)有所增加。这一转变的部分原因可能是发现羟氯喹和其他一些再利用药物缺乏疗效,再加上中和抗体的临床试验的出现。 该综述指出,治疗试验生态系统应具备两个关键能力,以便对COVID-19等以前未知疾病的暴发作出有效反应。首先,需要一个强大的筛选机制,通过机械学或非临床信息对重新使用的候选药物进行优先排序,并针对疫情相关的适应症进行快速评估。第二项要求是建立一个系统,以迅速和有效地生成关于安全、疗效和目标人群的明确的、高度可操作的信息,其质量应被负责制定护理标准的监管者和专家组认为可以接受。这两种能力都应高度响应与护理标准相关的新信息或试验结果。此外,当疾病的病程像COVID-19那样复杂时,对于进入临床试验的候选药物,必须充分评估疾病的多个阶段和表现。 绝大多数COVID-19疗法试验的设计并不是为了产生可操作的信息,低随机化率和不足的结果数据使安全性和有效性问题通常无法解释。这些试验中有许多被归入II期,这表明产生关键数据的程序性障碍。特别是在大流行病的紧迫背景下,快速筛选和II-III期的无缝过渡应有助于高效的决策,从而节省资源和优化入组。 原文链接:https://www.nature.com/articles/d41573-021-00037-3
  • 《Nature,9月13日,Obesity is a potential risk factor contributing to clinical manifestations of COVID-19》

    • 来源专题:COVID-19科研动态监测
    • 编译者:zhangmin
    • 发布时间:2020-09-16
    • Obesity is a potential risk factor contributing to clinical manifestations of COVID-19 Zhenyu Kang, Shanshan Luo, Yang Gui, Haifeng Zhou, Zili Zhang, Chunxia Tian, Qiaoli Zhou, Quansheng Wang, Yu Hu, Heng Fan & Desheng Hu International Journal of Obesity (2020) Abstract Background Since December 2019, novel coronavirus (SARS-CoV-2)-induced pneumonia (COVID-19) occurred in Wuhan, and rapidly spread throughout China. COVID-19 patients demonstrated significantly different outcomes in clinic. We aimed to figure out whether obesity is a risk factor influencing the progression and prognosis of COVID-19. Methods 95 patients with COVID-19 were divided into obesity group and non-obesity group according to their body mass index (BMI). The demographic data, clinical characteristics, laboratory examination, and chest computed tomography (CT) were collected, analyzed and compared between two groups. Results Our data showed that COVID-19 patients with obesity had more underlying diseases and higher mortality rate compared to those without obesity. Furthermore, patients with obesity also demonstrated more severe pathological change in lung and higher blood lymphocytes, triglycerides, IL-6, CRP, cystatin C, alanine aminotransferase (ALT), erythrocyte sedimentation rate (ESR), which may greatly influence disease progression and poor prognosis of COVID-19.