Efficacy and safety of the combination of Liushen capsules and Arbidol in the treatment of COVID-19:protocol for a randomized,multi-center pilot study  

作　　者：Yangqing Zhan Zhengtu Li Jiayang He Shaoqiang Li Ye Lin Jingyi Liang Jie Zhou Yanmei Wu Xuandan Su Feng Ye Zifeng Yang 

机构地区：[1]National Clinical Research Center for Respiratory Disease,Guangzhou Institute of Respiratory Health,First Affiliated Hospital of Guangzhou Medical University,State Key Laboratory of Respiratory Disease(Guangzhou Medical University),Guangzhou 510230,China [2]Guang Zhou Evidence-Based Medicine Technology Co.,Ltd,Guangzhou 510000,China [3]Macao Institute for Applied Research in Medicine and Health,State Key Laboratory of Quality Research in Chinese Medicine,Macao University of Science and Technology,Macao,999078,China

出　　处：《TMR Modern Herbal Medicine》2020年第4期202-208,共7页TMR现代中药

基　　金：This work was supported by the Science research project of the Guangdong Province[Grant No.2020B111110001];Guangzhou Medical University High-level University Clinical Research and Cultivation Program(Guangzhou Medical University released[2017]No.159,160).

摘　　要：Background:From early experience,some Traditional Chinese Medicine and Arbidol had effects of against COVID-19,infer that the combination of Liushen capsules and Arbidol may further increase the therapeutic.Methods/Design:We conducted a randomized,blank parallel-controlled,open-label,multi-center,basal therapy-loaded design clinical trial.A total of 40 patients are going to be recruited after satisfying the criteria.Participants will be allocated randomly into the treatment group with the combination of Arbidol and Liushen capsules and the control group with the basic therapy.Each group will receive treatment at least 7-days or until the virus becomes negative,and visits after drug administration at day 3(visit 1),the day when the virus becomes negative(visit 2),day 7(visit 3),the day before discharge(visit 4)and day 28(visit 5),to collect their survival status and disease prognosis so that the efficacy and safety of a combination of Arbidol and Liushen capsule will be evaluated.Discussion:We described the protocol of the first clinical trial for treatment COVID-19 by using a combination of Arbidol and Liushen capsules.The results of this study will provide a basis for the design and sample size estimate of subsequent large-scale clinical trials.Trial registration:This study has been registered at Chinese clinical trial Registry(chictr.org.cn):ChiCTR2000029993.

关 键 词：ARBIDOL Liushen capsules COVID-19 Clinical trial 

分 类 号：R73[医药卫生—肿瘤]