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: Feng Ye Jiayang He Jie Zhou Jingyi Liang Shaoqiang Li Xuandan Su Yangqing Zhan Yanmei Wu Ye Lin Zhengtu Li Zifeng Yang
• 来源期刊: TMR现代中药
• 学科: 医学
• 关键词: ARBIDOL Liushen capsules COVID-19 Clinical trial
• 年，卷（期）: 2020,（4）
• 页码范围: 202-208
• 页数: 7页
• 分类号: R73

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.