新型冠状病毒肺炎药物临床试验现状及研究进展

目的统计分析新型冠状病毒肺炎药物临床试验开展情况及研究进展,为其临床试验及临床治疗提供参考。方法以“新型冠状病毒肺炎”、“新冠病毒”、“COVID-19”、“nCoV”为关键词,在国内外临床试验注册网站、中国期刊全文数据库(CNKI)、中国生物医文献数据库(CBM)、Cochrane Library、PubMed等数据库,以及国家卫健委网站进行检索,提取和评价相关数据。结果截至2020年2月19日15时15分,来自中国临床试验注册中心和Clinicaltrials.gov登记显示相关项目已有202项,研究最多的为中西医治疗及抗病毒类药物治疗,抗病毒类药物中最多为洛匹那韦/利托那韦、其次是阿比多尔。随机平行对照有82项、多中心有27项、IV期临床试验40项、探索性研究/预试验39项。结论目前尚无特效治疗药物,也未发现有明确疗效的预防性药物,国家将依据药物临床试验结果及时将成果推荐给临床救治。

Status and Research Progress of Clinical Trials of COVID-19 Drugs

OBJECTIVE To statistically analyze the status and research progress of clinical trials of Coronavirus Disease 2019 drugs,in order to provide references for their clinical trials and clinical treatment.METHODS With the keywords of“Coronavirus Disease 2019”,“new coronavirus”,“COVID-19”and“nCoV”were searched on clinical trial registration websites at home and abroad,Chinese Journal Full-text Database(CNKI),Chinese Biomedical Literature Database(CBM),Cochrane library,PubMed and other databases,as well as the website of the National Health Commission,extracted and evaluated of relevant data.RESULTS As of 15:15 on February 19,2020,registrations from the China Clinical Trials Registry and Clinicaltrials.gov showed that there were 202 related projects.The most studied were traditional Chinese and western medicine treatment and antiviral treatment.The most antiviral drugs were Lopinavir/Ritonavir,followed by Arbidol.There were 82 randomized parallel controlled stduies,27 multicenters,40 phase IV clinical trials,and 39 exploratory studies/pre-trials.CONCLUSION At present,there are no specific therapeutic drugs,and no preventive drugs for COVID-19.The country will recommend the results to the clinical treatment based on the clinical trial results promptly.