Today is 2020-09-28

Cancelled by the investigator Combination of Tocilizumab, IVIG and CRRT in severe patients with novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030442 

最近更新日期:

Date of Last Refreshed on:

2020-03-14 

注册时间:

Date of Registration:

2020-03-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

研究者撤消 托珠单抗、丙种球蛋白、持续肾脏替代三联疗法在重症新型冠状病毒肺炎(COVID-19)的作用 

Public title:

Cancelled by the investigator Combination of Tocilizumab, IVIG and CRRT in severe patients with novel 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、丙种球蛋白、持续肾脏替代三联疗法在重症新型冠状病毒肺炎(COVID-19)中的有效性研究 

Scientific title:

The therapeutic efficacy of combination of Tocilizumab, IVIG and CRRT in sever patients with novel 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:

马肖容 

研究负责人:

马肖容 

Applicant:

Ma Xiaorong 

Study leader:

Ma Xiaorong 

申请注册联系人电话:

Applicant telephone:

+86 13992856156 

研究负责人电话:

Study leader's telephone:

+86 13992856156 

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:

maxr0910@163.com 

研究负责人电子邮件:

Study leader's E-mail:

maxr0910@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:

陕西省西安市西五路157号 

研究负责人通讯地址:

陕西省西安市西五路157号 

Applicant address:

157 West 5th Road, Xi'an, Shaanxi, China 

Study leader's address:

157 West 5th Road, Xi'an, Shaanxi, China 

申请注册联系人邮政编码:

Applicant postcode:

710004 

研究负责人邮政编码:

Study leader's postcode:

710004 

申请人所在单位:

西安交通大学第二附属医院 

Applicant's institution:

the Second Affiliated hospital of Xi'an Jiaotong University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

西安交通大学第二附属医院 

Primary sponsor:

the Second Affiliated hospital of Xi'an Jiaotong University 

研究实施负责(组长)单位地址:

陕西省西安市西五路157号 

Primary sponsor's address:

157 West 5th Road, Xi'an, Shaanxi, 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):

陕西

市(区县):

西安

Country:

China

Province:

Shaanxi

City:

Xi'an

单位(医院):

西安交通大学第二附属医院

具体地址:

陕西省西安市西五路157号

Institution
hospital:

the Second Affiliated hospital of Xi'an Jiaotong University

Address:

157 West 5th Road

经费或物资来源:

自筹 

Source(s) of funding:

Self-funded 

研究疾病:

新型冠状病毒肺炎 

Target disease:

Coronavirus Disease 2019 

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:

探索性研究/预试验 

Study phase:

研究目的:

托珠单抗已被批准用于新型冠状病毒肺炎的治疗,但由于其靶点单一及干扰机体免疫功能,在治疗中有一定局限性,丙种球蛋白和持续性肾脏替代疗法,可以很好解决以上问题,因此我们提出将三者合用可以最大限度发挥效能,救治重症患者,本研究旨在观察三联疗法方案在重症患者救治中的作用。 

Objectives of Study:

Tocilizumab has been approved to treat the COVID-19, but its limitation and adverse effects should be addressed. IVIG and CRRT can be good supplement of tocilizumab. We proposed a combo regimen of Tocilizumab+IVIG+CRRT for severe patients. This study is to verify the effect of this combo regimen in severe case of COVID-19. 

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:

重症新冠肺炎患者 

Inclusion criteria

severe case of COVID-19 

排除标准:

药物过敏 妊娠患者 

Exclusion criteria:

Allergy to any medicine Pregnancy 

研究实施时间:

Study execute time:

From2020-03-05To 2020-05-15 

征募观察对象时间:

Recruiting time:

From2020-03-05To 2020-04-30 

干预措施:

Interventions:

组别:

Case series

样本量:

100

Group:

Case series

Sample size:

干预措施:

托珠单抗、丙种球蛋白、持续肾脏替代三联疗法

干预措施代码:

Intervention:

Combination of Tocilizumab, IVIG and CRRT

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

住院时间

指标类型:

主要指标 

Outcome:

Inhospital time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

存活率

指标类型:

次要指标 

Outcome:

Survival rate

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:

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 20 years
最大 Max age 90 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

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 ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

2020.10.30 临床研究公共管理平台

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

2020.10.30 ResMan

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+电子采集和管理系统

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

CRF+EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-02
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