洛匹那韦/利托那韦联合恩曲他滨/丙酚替诺福韦方案用于新型冠状病毒肺炎治疗的临床研究方案(TARCoV研究)

A combination regimen by lopinave/litonawe,emtricitabine and tenofovir alafenamide fumarate for treatment of novel coronavirus pneumonia(TARCoV)

目的探索以洛匹那韦/利托那韦(lopinave/litonawe,LPV/r)为骨干药物,联合恩曲他滨(emtricitabine,FTC)/丙酚替诺福韦(tenofovir alafenamide fumarate,TAF)FTC/TAF的联合抗病毒方案用于新型冠状病毒肺炎患者早期治疗的临床疗效。方法为真实世界临床研究,分为前瞻性干预队列(T1)和历史对照队列(T2)两组。T1组拟纳入确诊NCP的轻型和普通型患者90例,入组患者均为接受国家卫健委推荐的标准治疗方案,并均采用LPV/r+FTC/TAF联合用药。T2组为接受LPV/r抗病毒治疗的历史病例匹配组,共90例。比较两组患者生存率、病毒核酸转阴时间、发展成为ARDS率及住院时间等主要结局指标。结论本试验是一项真实世界临床研究,有望为临床工作者提供一种更加高效和快速的抗病毒疗法,本研究的实施还将进一步帮助其筛选有效治疗药物。

Objective To explore the efficacy of a combination regimen by Lopinave/Litonawe(LPV/r),emtricitabine and tenofovir alafenamide fumarate(FTC/TAF)for the treatment of novel coronavirus pneumonia.Methods We design the protocol as a real world study,which includes two groups:prospective intervention cohort(T1)and historical control group(T2).For the T1 group,ninety patients who are diagnosed as NCP will be enrolled.All patients in the T1 group will receive standard therapies following the recommendation in the Guidelines of National Commission of Health,and will be administered an anti-virus regimen including LPV/r and FTC/TAF.The T2 group will enroll patients who have received single regimen of LPV/r.The major outcome is the survival rate of patients.Secondary outcomes are the time of seroconversion of RNA,ARDS progression rate and length of hospital stay.Conclusions The results of this real world study might provide clinical practitioners a high efficiency and fast antivirus regimen for novel coronavirus pneumonia patients.In addition,the conduction of this study will accelerate screening for other new effective therapeutic method.