今天是:2020-07-14 星期二

洛匹那韦/利托那韦(LPV/r)+恩曲他滨(FTC)/丙酚替诺福韦(TAF)用于治疗新型冠状病毒肺炎(COVID-19)的临床研究
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注册号:

Registration number:

ChiCTR2000029468 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

洛匹那韦/利托那韦(LPV/r)+恩曲他滨(FTC)/丙酚替诺福韦(TAF)用于治疗新型冠状病毒肺炎(COVID-19)的临床研究 

Public title:

A real-world study for lopinavir/ritonavir (LPV/r) and emtritabine (FTC) / Tenofovir alafenamide Fumarate tablets (TAF) regimen in the treatment of novel coronavirus pneumonia (COVID-19) 

注册题目简写:

三种抗病毒药物联合治疗2019新型冠状病毒肺炎 

English Acronym:

TARCoV study 

研究课题的正式科学名称:

洛匹那韦/利托那韦(LPV/r)+恩曲他滨(FTC)/丙酚替诺福韦(TAF)早期用于治疗新型冠状病毒肺炎(COVID-19)的真实世界临床研究 

Scientific title:

The early use of lopinavir/litonavir (LPV/r) and emtritabine (FTC)/ Tenofovir alafenamide Fumarate tablets (TAF) regimen in the treatment of the novel coronavirus pneumonia (COVID-19): a real-world study 

研究课题代号(代码):

Study subject ID:

2020YFS0006 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

李庭 

研究负责人:

江华 

Applicant:

Li Ting 

Study leader:

Jiang Hua 

申请注册联系人电话:

Applicant telephone:

+86 15549570621 

研究负责人电话:

Study leader's telephone:

+86 028 87393881 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

1756813438@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

cdjianghua@qq.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

四川省成都市一环路西二段32号 

研究负责人通讯地址:

四川省成都市一环路西二段32号 

Applicant address:

32 Second Section, First Ring Road West, Chengdu, Sichuan, China 

Study leader's address:

32 Second Section, First Ring Road West, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

610072 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

四川省医学科学院·四川省人民医院 

Applicant's institution:

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

伦审(研)2020年第96号 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

四川省医学科学院·四川省人民医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Sichuan Provincial People's Hospital, Sichuan Academy of Medical Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-02 

伦理委员会联系人:

曹柳 

Contact Name of the ethic committee:

Cao Liu 

伦理委员会联系地址:

四川省成都市一环路西二段32号 

Contact Address of the ethic committee:

32 Second Section, First Ring Road West, Chengdu, Sichuan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

四川省医学科学院·四川省人民医院急诊医学与灾难医学研究所 

Primary sponsor:

Institute of Emergency Medicine and Disaster Medicine Sichuan People's Hospital, Sichuan Academy of Medical Sciences  

研究实施负责(组长)单位地址:

四川省成都市一环路西二段32号 

Primary sponsor's address:

32 Second Section, First Ring Road West, Chengdu, Sichuan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川省

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

四川省医学科学院·四川省人民医院

具体地址:

四川省成都市一环路西二段32

Institution
hospital:

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Address:

32 Second Section, First Ring Road West, Chengdu

国家:

中国

省(直辖市):

四川省

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

成都市公共卫生临床医疗中心

具体地址:

成都市锦江区静居寺18号

Institution
hospital:

Chengdu public health clinical medical center

Address:

18 Jing-Ju-Si, Jinjiang District, Chengdu

经费或物资来源:

四川省科技厅(2020YFS0006) 

Source(s) of funding:

Department of science and technology of sichuan province (2020YFS0006) 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

novel coronavirus pneumonia (COVID-19) 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

探索LPV/r联合FTC/TAF用于早期治疗2019-nCoV肺炎的临床效应,提高抗病毒药物对此类患者的救治成功率,控制疫情蔓延。 

Objectives of Study:

To explore the clinical effect of LPV/r combined with FTC/TAF in the early treatment of 2019-ncov pneumonia, improve the success rate of antiviral treatment for such patients, and control the spread of the epidemic. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1)确诊为2019-nCoV感染肺炎; 2)成年患者,18-80岁。 

Inclusion criteria

1. diagnosis of 2019-new coronavirus (2019-nCoV) pneumonia; 2. adult patients aged 18-80 years old. 

排除标准:

1)感染后未行抗病毒治疗即发展为ARDS; 2)感染前患有HBV、HIV、胰腺炎、肝内胆管结石或有上述既往史; 3)感染前有严重心、肝、肾及呼吸系统疾病; 4)骨质疏松等代谢及内分泌疾病史; 5)妊娠期或哺乳期妇女; 6)精神状态不能合作者,患有精神性疾病、无自制力、不能明确表达者; 7)正参加其它临床试验。 

Exclusion criteria:

1. ARDS was developed after infection without antiviral treatment; 2. suffering from HBV, HIV, pancreatitis, intrahepatic bile duct stones or having the previous history mentioned above ; 3. severe heart, liver, kidney and respiratory diseases before infection; 4. history of metabolic and endocrine diseases such as osteoporosis; 5. pregnant or nursing women; 6. those who are unable to cooperate in mental state, suffer from mental disease, have no self-control and cannot express clearly; 7. participating in other clinical trials. 

研究实施时间:

Study execute time:

From2020-02-01To 2020-06-30 

干预措施:

Interventions:

组别:

实验组

样本量:

60

Group:

experimental group

Sample size:

干预措施:

洛匹那韦/利托那韦(LPV/r)+恩曲他滨(FTC)/丙酚替诺福韦(TAF)三联用药

干预措施代码:

Intervention:

Lopinavir/litonavir (LPV/r)+ emtritabine (FTC)/ Tenofovir alafenamide Fumarate tablets (TAF) in combination

Intervention code:

组别:

历史对照组

样本量:

60

Group:

Historical Control

Sample size:

干预措施:

洛匹那韦/利托那韦

干预措施代码:

Intervention:

LPV/r

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川省医学科学院·四川省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital  

Level of the institution:

Tertiary A Hosptital 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

成都市公共卫生临床医疗中心 

单位级别:

三级甲等 

Institution
hospital:

Chengdu public health clinical medical center  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

患者生存率

指标类型:

主要指标 

Outcome:

Patient survival rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病毒核酸转阴时间

指标类型:

次要指标 

Outcome:

Viral nucleic acid turns negative time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发展成为ARDS患者率

指标类型:

次要指标 

Outcome:

Develop into ARDS patient rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

次要指标 

Outcome:

length of hospital stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

不适用

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

公开时间为2020年12月,平台为四川省人民医院官网

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

The time of data sharing shall be December 2020, and the platform is the official website of Sichuan Provincial People's Hospital

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

数据采集是通过病例记录本,管理系统为四川省人民医院的系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Data collection is through the case book, and the management system is the system of sichuan provincial people's hospital

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-02
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