抗SARS-CoV-2抗体产品治疗COVID-19的使用建议及临床试验证据  

Recommendations and clinical trial evidence for use of Anti-SARS-CoV-2 antibody products for the treatment of COVID-19

作　　者：饶亚岚 于爱平 王延琳 熊文翔 高晨燕 RAO Ya-lan;YU Ai-ping;WANG Yan-lin;XIONG Wen-xiang;GAO Chen-yan(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国临床药理学杂志》2021年第14期1947-1952,共6页The Chinese Journal of Clinical Pharmacology

摘　　要：2019冠状病毒病(COVID-19)是严重急性呼吸综合征冠状病毒(SARS-CoV-2)引起的新发急性呼吸道传染病,目前已形成世界大流行。本文重点综述目前美国国立卫生研究院(NIH)、美国食品药品监督管理局(FDA)及中国国家卫生健康委员会对抗SARS-CoV-2抗体产品治疗COVID-19的使用建议以及相关临床试验证据,为该类产品的临床审评及研发提供参考。截至2021年2月,NIH认为没有足够的临床试验数据以支持或反对抗SARS-CoV-2抗体产品(包括COVID-19康复者恢复期血浆、单克隆抗体及特异免疫球蛋白)用于治疗COVID-19。FDA基于对已有的临床试验数据的评估,先后发布康复者恢复期血浆及3项抗SARS-CoV-2单克隆抗体治疗COVID-19的紧急使用授权(EUAs),支持这些EUAs的临床试验证据尚不够充分,存在一定局限性。中国国家卫生健康委员会也对康复者恢复期血浆和SARS-CoV-2特异免疫球蛋白治疗COVID-19给出了建议。中美有关机构的具体建议存在差异,但均认可紧急使用,这些建议尚缺乏充分明确的临床试验证据。目前正在开展的随机对照临床试验需确定此类产品治疗COVID-19的可能获益人群及治疗时间窗,预期这些产品在疾病早期使用更有效。随着临床试验的进展,相信会有更多的抗SARS-CoV-2抗体产品可用于治疗COVID-19。Coronavirus disease 2019(COVID-19)is a new acute respiratory infectious disease caused by severe acute respiratory syndrome coronavirus 2(SARS-COV-2),and it has become a world pandemic.This paper focuses on recommendations for use of anti SARS COV-2 antibody products for the treatment of COVID-19 by American National Institutes of Health(NIH),American Food and Drug Administration(FDA)and the National Health Commission of China,as well as the relevant clinical trial evidence,so as to provide reference for the clinical evaluation and development of such products.Up to February 2021,NIH considers there are insufficient data to recommend either for or against the use of anti SARS-COV-2 antibody products(including COVID-19 convalescent plasma,monoclonal antibody and specific immunoglobulin)for the treatment of COVID-19.Based on the evaluation of the existing clinical trial data,FDA has issued emergency use authorizations(EUAs)for convalescent plasma and three kinds of anti SARS-COV-2 monoclonal antibodies for the treatment of COVID-19.The evidence supporting these EUAs is insufficient and has some limitations.The National Health Commission of China has also given recommendations for use of convalescent plasma and SARS COV-2 specific immunoglobulin for the treatment of COVID-19.The recommendations of the relevant institutions in China and the United States are different,but reach an agreement on emergency use.These recommendations are still lack of sufficient and clear evidence of clinical trials.The randomized controlled clinical trials under way need to identify the potential beneficiaries and therapeutic window for the treatment of COVID-19 with such products.These products are expected to be more effective in the early stages of disease.With the development of clinical trials,it is believed that more anti SARS COV-2 antibody products will be effective for the treatment of COVID-19.

关 键 词：2019冠状病毒病 严重急性呼吸综合征冠状病毒 康复者恢复期血浆 单克隆抗体 特异免疫球蛋白 

分 类 号：R978.7[医药卫生—药品]