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托珠单抗在新型冠状病毒肺炎(COVID-19)中的有效性及安全性的多中心、随机对照 临床研究
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注册号:

Registration number:

ChiCTR2000029765 

最近更新日期:

Date of Last Refreshed on:

2020-02-13 

注册时间:

Date of Registration:

2020-02-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

托珠单抗在新型冠状病毒肺炎(COVID-19)中的有效性及安全性的多中心、随机对照 临床研究 

Public title:

A multicenter, randomized controlled trial for the efficacy and safety of tocilizumab in the treatment of new coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

托珠单抗在新型冠状病毒肺炎(COVID-19)中的有效性及安全性的多中心、随机对照 临床研究 

Scientific title:

A multicenter, randomized controlled trial for the efficacy and safety of tocilizumab in the treatment of new coronavirus pneumonia (COVID-19) 

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:

王东升 

研究负责人:

徐晓玲 

Applicant:

Dongsheng Wang 

Study leader:

Xiaoling Xu 

申请注册联系人电话:

Applicant telephone:

+86 15605519676 

研究负责人电话:

Study leader's telephone:

+86 18963789002 

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:

15605519676@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xxlahh08@163.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:

安徽省合肥市庐阳区庐江路17号 

研究负责人通讯地址:

安徽省合肥市庐阳区庐江路17号 

Applicant address:

17 Lujiang Road, Luyang District, Hefei, Anhui, China 

Study leader's address:

17 Lujiang Road, Luyang District, Hefei, Anhui, 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:

中国科学技术大学附属第一医院(安徽省立医院) 

Applicant's institution:

The First Affiliated Hospital of University of science and technology of China (Anhui Provincial 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:

2020-XG(H)-008 

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:

中国科学技术大学附属第一医院(安徽省立医院) 伦理委员会 

Name of the ethic committee:

The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital) Ethics committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-11 

伦理委员会联系人:

陈梅男 

Contact Name of the ethic committee:

Meinan Chen 

伦理委员会联系地址:

安徽省合肥市庐阳区庐江路17号 

Contact Address of the ethic committee:

17 Lujiang Road, Luyang District, Hefei, Anhui, 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:

中国科学技术大学附属第一医院(安徽省立医院) 

Primary sponsor:

The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital) 

研究实施负责(组长)单位地址:

安徽省合肥市庐阳区庐江路17号 

Primary sponsor's address:

17 Lujiang Road, Luyang District, Hefei, Anhui, 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):

安徽省

市(区县):

Country:

China

Province:

Anhui

City:

单位(医院):

中国科学技术大学附属第一医院(安徽省立医院)

具体地址:

安徽省合肥市庐阳区庐江路17号

Institution
hospital:

The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital)

Address:

17 Lujiang Road, Luyang District, Hefei

经费或物资来源:

安徽省科技厅 

Source(s) of funding:

Department of science and technology of Anhui Province 

研究疾病:

新型冠状病毒肺炎 

Target disease:

new coronavirus pneumonia 

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:

上市后药物 

Study phase:

研究目的:

评估托珠单抗治疗普通型NCP(含重症高危因素)及重型NCP患者的有效性和安全性 

Objectives of Study:

To evaluate the efficacy and safety of tocilizumab in treating regular patients with NCP (including severe risk factors) and critical NCP patients. 

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) 确诊新型冠状病毒肺炎的普通型NCP(含重症高危因素)、重型患者; (2) 18岁≤年龄<85岁 (3) IL-6升高(统一由项目组实验室检测,采用Elisa方法); (4) 患者及家属自愿参与本项研究并签署知情同意书。 注:病例定义:(1) 普通型NCP(含重症高危因素):普通型合并双肺病变患者;(2) 重型NCP:参考国家卫健委制定《新型冠状病毒肺炎诊疗方案(第五版)》。 

Inclusion criteria

1. The patients who were diagnosed with the common type of NCP (including severe risk factors) and severe cases of new coronavirus pneumonia; 2. Aged 18 to 85 years; 3. IL-6 elevated (using Elisa method, using the same company kit); 4. Patients or authorized family members volunteered to participate in this study and signed informed consent. Definition of Novel Coronavirus Pneumonia (NCP) clinical cases: 1. Regular patients with NCP (including severe risk factors): patients with dual pulmonary lesions based on common NCP clinical symptoms accompanied by fever or no fever; 2. Critical NCP patient: Refer to the "New Coronavirus Pneumonia Diagnosis and Treatment Plan (Fifth Edition)" formulated by the National Health Commission. 

排除标准:

(1) 正在参加其他药物临床试验患者; (2) 孕妇或哺乳期的女性; (3) ALT/AST>5倍ULN,中性粒细胞<0.5,血小板小于50; (4) 预期生存期<1周; (5) 明确诊断有风湿免疫相关疾病; (6) 长期口服抗排斥药物或者免疫调节药物; (7) 对托珠单抗或任何辅料发生超敏反应者; (8) 肺结核患者; (9) 目前存在严重细菌感染、真菌感染证据患者。 

Exclusion criteria:

1. Patients who are participating in other drug clinical trials; 2. Pregnant or lactating women; 3. ALT / AST> 5 ULN, neutrophils <0.5, platelets less than 50; 4. Definite diagnosis of rheumatic immune-related diseases; 5. Long-term oral anti-rejection or immunomodulatory drugs; 6. Hypersensitivity to tocilizumab or any excipients; 7. Patients with active pulmonary tuberculosis, with definite bacterial and fungal infections. 

研究实施时间:

Study execute time:

From2020-02-10To 2020-05-10 

干预措施:

Interventions:

组别:

对照组

样本量:

94

Group:

control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

conventional therapy

Intervention code:

组别:

实验组

样本量:

94

Group:

Experience group

Sample size:

干预措施:

常规治疗+托珠单抗

干预措施代码:

Intervention:

conventional therapy+tocilizumab

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

安徽省 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

中国科学技术大学附属第一医院(安徽省立医院) 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital)  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

治愈率

指标类型:

主要指标 

Outcome:

cure 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:

病死率

指标类型:

次要指标 

Outcome:

mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸机使用

指标类型:

次要指标 

Outcome:

Ventilator utilization

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院日

指标类型:

次要指标 

Outcome:

Hospitalization day

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 85 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):

采用SAS软件的proc plan过程,生成随机数字,并随机分为两组,分别为试验组和对照组。筛选合格受试者按照进入研究中心的时间先后顺序,以1:1的比例随机分配到试验组和对照组。

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

The procplan program of SAS software was used to generate random numbers and randomly them divided into two groups, namely the experimental group and the control group. Qualified subjects were randomly assigned to the experimental group and the control group at a 1: 1 ratio in accordance with the chrono

盲法:

未说明

Blinding:

Not stated

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):

论文发表

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

Publication of papers

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:

病例记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-13
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