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加速 2019 年冠状病毒病治疗干预措施和疫苗的研发——选择用于 2019 年冠状病毒病临床试验的临床评估化合物。

Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines-Selecting Compounds for Clinical Evaluation in Coronavirus Disease 2019 Clinical Trials.

机构信息

Biomedical Advanced Research and Development Authority (BARDA), Office of Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services, Washington, DC.

The Janssen Pharmaceutical Companies of Johnson & Johnson, Spring House, PA.

出版信息

Crit Care Med. 2021 Nov 1;49(11):1963-1973. doi: 10.1097/CCM.0000000000005295.

DOI:10.1097/CCM.0000000000005295
PMID:34495876
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8507598/
Abstract

Given the urgent need for coronavirus disease 2019 therapeutics, early in the pandemic the Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership rapidly designed a unique therapeutic agent intake and assessment process for candidate treatments of coronavirus disease 2019. These treatments included antivirals, immune modulators, severe acute respiratory syndrome coronavirus 2 neutralizing antibodies, and organ-supportive treatments at both the preclinical and clinical stages of development. The ACTIV Therapeutics-Clinical Working Group Agent Prioritization subgroup established a uniform data collection process required to perform an assessment of any agent type using review criteria that were identified and differentially weighted for each agent class. The ACTIV Therapeutics-Clinical Working Group evaluated over 750 therapeutic agents with potential application for coronavirus disease 2019 and prioritized promising candidates for testing within the master protocols conducted by ACTIV. In addition, promising agents among preclinical candidates were selected by ACTIV to be matched with laboratories that could assist in executing rigorous preclinical studies. Between April 14, 2020, and May 31, 2021, the Agent Prioritization subgroup advanced 20 agents into the Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines master protocols and matched 25 agents with laboratories to assist with preclinical testing.

摘要

鉴于对 2019 年冠状病毒病治疗方法的迫切需求,大流行早期,加速 2019 年冠状病毒病治疗干预和疫苗公私伙伴关系迅速为 2019 年冠状病毒病候选治疗方法设计了独特的治疗药物摄入和评估流程。这些治疗方法包括在临床前和临床开发阶段的抗病毒药物、免疫调节剂、严重急性呼吸系统综合征冠状病毒 2 中和抗体和器官支持治疗。ACTIV 治疗学-临床工作组代理优先排序分组建立了一个统一的数据收集流程,该流程需要使用为每个代理类别确定和差异化加权的审查标准,对任何代理类型进行评估。ACTIV 治疗学-临床工作组评估了超过 750 种具有 2019 年冠状病毒病应用潜力的治疗药物,并为 ACTIV 进行的主要方案中测试有前途的候选药物确定了优先顺序。此外,ACTIV 还选择了临床前候选药物中的有前途的药物,与可以协助进行严格临床前研究的实验室进行匹配。2020 年 4 月 14 日至 2021 年 5 月 31 日,代理优先排序分组将 20 种药物推进到加速 2019 年冠状病毒病治疗干预和疫苗主要方案中,并将 25 种药物与实验室进行匹配,以协助进行临床前测试。

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