摘要
Abstract
To summarize and analyze clinical development strategy and the key considerations of clinical trial design of drugs for the treatment of corona virus disease 2019(COVID-19)at home and abroad in recent years,including ribonucleic acid(RNA)polymerase inhibitors,3CL protease inhibitors,and neutralizing antibodies,etc.In general,the confirmatory clinical trials for therapeutic drugs for CO VID-19 typically adopt a randomized,double blind,placebo-controlled clinical trials using a superiority design.Based on their therapeutic positioning,most trials mainly enroll patients with mild to moderate COVID-19,with or without high-risk of complications,and the primary efficacy endpoints are the proportion of patients hospitalized or mortality by an appropriate time point,or the time to sustained clinical recovery assessed over an appropriate duration.Through reviewing drug development during the CO VID-19 pandemic,this paper summarized the considerations and changes for clinical research and development,as well as the focus of clinical trial design for new drugs in the treatment of COVID-19,in the context of emerging and sudden major infectious diseases,hoping to provide references for drug research and development.关键词
治疗药物/新型冠状病毒感染/临床研发/临床试验设计Key words
therapeutic drugs/corona virus disease 2019/clinical research and development/clinical trial design分类
医药卫生
