今天是:2020-04-01 星期三

利巴韦林联合干扰素-α,洛匹那韦/利托那韦联合干扰素-α及利巴韦林联合洛匹那韦/利托那韦联合干扰素-α对轻中度新型冠状病毒肺炎患者有效性和安全性的随机对照研究
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注册号:

Registration number:

ChiCTR2000029387 

最近更新日期:

Date of Last Refreshed on:

2020-03-02 

注册时间:

Date of Registration:

2020-01-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

利巴韦林联合干扰素-α,洛匹那韦/利托那韦联合干扰素-α及利巴韦林联合洛匹那韦/利托那韦联合干扰素-α对轻中度新型冠状病毒肺炎患者有效性和安全性的随机对照研究 

Public title:

Comparative effectiveness and safety of ribavirin plus interferon-alpha, lopinavir/ritonavir plus interferon-alpha and ribavirin plus lopinavir/ritonavir plus interferon-alphain in patients with mild to moderate novel coronavirus pneumonia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

利巴韦林联合干扰素-α,洛匹那韦/利托那韦联合干扰素-α及利巴韦林联合洛匹那韦/利托那韦联合干扰素-α对轻中度新型冠状病毒肺炎患者有效性和安全性的随机对照研究 

Scientific title:

Comparative effectiveness and safety of ribavirin plus interferon-alpha, lopinavir/ritonavir plus interferon-alpha and ribavirin plus lopinavir/ritonavir plus interferon-alphain in patients with mild to moderate novel coronavirus pneumonia 

研究课题代号(代码):

Study subject ID:

 

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:

曾妍茗 

研究负责人:

陈耀凯 

Applicant:

Yanming Zeng 

Study leader:

Yaokai Chen 

申请注册联系人电话:

Applicant telephone:

+86 023-65481658 

研究负责人电话:

Study leader's telephone:

+86 023-65481658 

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:

doczym@163.com 

研究负责人电子邮件:

Study leader's E-mail:

yaokaichen@hotmail.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:

重庆市沙坪坝区歌乐山镇109号重庆市公共卫生医疗救治中心 

研究负责人通讯地址:

重庆市沙坪坝区歌乐山镇109号重庆市公共卫生医疗救治中心 

Applicant address:

109 Baoyu Road, Shapingba District, Chongqing, China 

Study leader's address:

109 Baoyu Road, Shapingba District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

重庆市公共卫生医疗救治中心 

Applicant's institution:

Chongqing Public Health Medical Center 

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:

2020-002-01-KY 

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:

重庆市公共卫生医疗救治中心伦理委员会 

Name of the ethic committee:

The Institution Review Board of Chongqing Public Health Medical Center 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-28 

伦理委员会联系人:

陈亚玲 

Contact Name of the ethic committee:

Yaling Chen 

伦理委员会联系地址:

重庆市沙坪坝区109号重庆市公共卫生医疗救治中心 

Contact Address of the ethic committee:

Chongqing Public Health Medical Center, 109 Baoyu Road, Shapingba District, Chongqing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 023-65518197 

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:

重庆市公共卫生医疗救治中心 

Primary sponsor:

Chongqing Public Health Medical Center 

研究实施负责(组长)单位地址:

重庆市沙坪坝区歌乐山镇109号重庆市公共卫生医疗救治中心 

Primary sponsor's address:

109 Baoyu Road, Shapingba District, Chongqing, 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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆市公共卫生医疗救治中心

具体地址:

重庆市沙坪坝区歌乐山镇109号重庆市公共卫生医疗救治中心

Institution
hospital:

Chongqing Public Health Medical Center

Address:

109 Baoyu Road, Shapingba District, Chongqing, China

经费或物资来源:

重庆市科学技术委员会 

Source(s) of funding:

Chongqing Science and Technology Bureau 

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:

评价三种抗病毒方案治疗轻中度新型冠状病毒感染的肺炎患者的疗效和安全性。 

Objectives of Study:

Comparison of efficacy and safety of three antiviral regimens in patients with mild to moderate novel coronavirus pneumonia. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)年龄18~65岁; (2)确诊为普通型新型冠状病毒感染的肺炎患者; (3)自愿签署受试者知情同意书,并愿意接受随访; (4)研究者认为,受试者总体状况不影响试验的评估和完成。 

Inclusion criteria

(1) 18–65 years of age; (2) Diagnosed as mild to moderate COVID-19; (3) Be willing to sign informed consent; (4) The clinical assessment and condition of the subject does not influence the completion of the study.  

排除标准:

(1)排除重度、危重度新型冠状病毒感染的肺炎; (2)妊娠期和哺乳期妇女; (3)入选时检测到以下结果:ALT和AST>正常值的5倍,肌酐清除率<50 ml/min; (4)对LPV/r和利巴韦林、干扰素过敏者; (5)HIV感染者; (6)血红蛋白病患者; (7)有严重心、脑、肺、肾、肿瘤等基础疾病; (8)未获得知情同意者; 

Exclusion criteria:

(1) Patients are diagnosed as a case of severe NCIP; (2) Patients are pregnant or breastfeeding women; (3) Patients have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5×UNL or creatinine clearance <50 ml / min; (4) Patients are allergic or intolerant to the proposed antiviral therapeutic drugs; (5) Patients are HIV-positive; (6) Patients with hemoglobin disease (7) Patients have severe heart disease, brain disease, lung disease, kidney disease, tumor or other severe systemic diseases; (8) Patients are not willing to provide signed informed consent.  

研究实施时间:

Study execute time:

From2020-01-25To 2021-01-25 

干预措施:

Interventions:

组别:

A组

样本量:

36

Group:

arm A

Sample size:

干预措施:

利巴韦林+干扰素α-1b

干预措施代码:

Intervention:

Ribavirin + Interferon alpha-1b

Intervention code:

组别:

B组

样本量:

36

Group:

arm B

Sample size:

干预措施:

洛匹那韦/利托那韦+干扰素α-1b

干预措施代码:

Intervention:

lopinavir / ritonavir + interferon alpha-1b

Intervention code:

组别:

C组

样本量:

36

Group:

arm C

Sample size:

干预措施:

利巴韦林+洛匹那韦/利托那韦+干扰素α-1b

干预措施代码:

Intervention:

Ribavirin + LPV/r+Interferon alpha-1b

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆市公共卫生医疗救治中心 

单位级别:

三级医院 

Institution
hospital:

Chongqing Public Health Medical Center  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

2019-nCoV RNA 转阴所需时间(天)

指标类型:

主要指标 

Outcome:

The time to 2019-nCoV RNA negativity in patients

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第28天病死率

指标类型:

次要指标 

Outcome:

mortality on day 28

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

2019-nCoV RNA 14天转阴率

指标类型:

次要指标 

Outcome:

The rate of negative 2019-nCoV RNA results at day 14

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

重症化率

指标类型:

次要指标 

Outcome:

the rate of aggravation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良反应率

指标类型:

次要指标 

Outcome:

the rate of adverse events

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

因不良反应停药的发生率

指标类型:

次要指标 

Outcome:

The rate of discontinuations due to adverse events

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:

咽拭子

组织:

Sample Name:

Throat swab

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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:

标本中文名:

肛拭

组织:

Sample Name:

Anal swab

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

组织:

Sample Name:

sputum

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 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):

由研究负责人进行临床诊断后确定纳入研究的受试者,再由Excel生成随机方案。

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

Subjects included in the study after clinical diagnosis by the research leader, then use Excel to generate random schemes.

盲法:

未说明

Blinding:

Not stated

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:

即时公开/Real time access

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):

研究完成后,我们将通过发表的医学期刊文章和会议报告分享研究结果。

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

We will share the results through published medical journal articles and at conference presentation after completion of the study.

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:

所有数据将记录在病例报告表(CRF)上,并通过医学研究平台立即记录在数据库中。

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

All data will be documented on case report forms (CRFs) and immediately recorded in the database through the Medical Research Platform.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-01-29
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