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创新的 COVID-19 医疗对策研发方法。

Innovative approaches to COVID-19 medical countermeasure development.

机构信息

Emory University School of Medicine, Department of Medicine, Atlanta, GA, USA.

Johns Hopkins Center for Health Security, Bloomberg School of Public Health, Baltimore, MD, USA.

出版信息

J Antimicrob Chemother. 2023 Nov 23;78(Suppl 2):ii18-ii24. doi: 10.1093/jac/dkad312.

Abstract

BACKGROUND

The COVID-19 pandemic, while unfortunately notable for immense strain and death throughout the world, has also shown great promise in the development of medical countermeasures. As the global scientific community shifted almost entirely towards vaccines, diagnostics and therapeutics, new trial designs most significantly adaptive platform trials, began to be used with greater speed and broader reach. These designs allowed for deploying and investigating new therapeutics, repurposing currently existing therapeutics and flexibly removing or adding additional medications as data appeared in real-time. Moreover, public-private sector partnering occurred at a level not seen before, contributing greatly to the rapid development and deployment of vaccines.

OBJECTIVES

To provide a brief overview of the advances in preventative and therapeutic medical countermeasure development for COVID-19.

METHODS

A narrative review of relevant major medical countermeasure trials was conducted using the date range February 2020-December 2022, representing the period of greatest productivity in research to investigate COVID-19.

RESULTS

Among the most influential trial designs are the adaptive platform designs, which have been applied to the development of initial COVID-19 antivirals, monoclonal antibodies, repurposing of existing immunomodulatory therapy and assisted in the disproof of ineffective medical therapies. Some of the most prominent examples include the REMAP-CAP, RECOVERY and TOGETHER trials.

CONCLUSIONS

Adaptive platform trial designs hold great promise for utility in future pandemics and mass casualty events. Additionally, public-private sectoring is essential for rapid medical countermeasure development and should be further enhanced for future biopreparedness.

摘要

背景

COVID-19 大流行虽然在全球范围内造成了巨大的压力和死亡,但也在医疗对策的发展方面展现了巨大的潜力。随着全球科学界几乎完全转向疫苗、诊断和治疗方法,新的试验设计——尤其是适应性平台试验——开始以更快的速度和更广泛的范围得到应用。这些设计允许部署和研究新的治疗方法,重新利用现有的治疗方法,并根据实时数据灵活地添加或删除其他药物。此外,公私部门的合作以前所未有的水平进行,为疫苗的快速开发和部署做出了巨大贡献。

目的

简要概述 COVID-19 预防性和治疗性医疗对策的发展进展。

方法

使用 2020 年 2 月至 2022 年 12 月的日期范围,对相关主要医疗对策试验进行叙述性综述,这一时期是研究 COVID-19 的研究成果最丰富的时期。

结果

最具影响力的试验设计之一是适应性平台设计,它已应用于最初的 COVID-19 抗病毒药物、单克隆抗体、现有免疫调节治疗方法的重新利用,并有助于证明无效的医疗方法无效。一些最突出的例子包括 REMAP-CAP、RECOVERY 和 TOGETHER 试验。

结论

适应性平台试验设计在未来的大流行和大规模伤亡事件中具有很大的应用潜力。此外,公私部门合作对于快速开发医疗对策至关重要,应该为未来的生物备灾进一步加强。

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