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A multicenter, single arm, open label trial for the efficacy and safety of CMAB806 in the treatment of cytokine release syndrome of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030196 

最近更新日期:

Date of Last Refreshed on:

2020-02-25 

注册时间:

Date of Registration:

2020-02-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项评估CMAB806治疗新型冠状病毒肺炎(COVID-19)患者细胞因子释放综合征的疗效和安全性的单臂、开放、多中心临床试验 

Public title:

A multicenter, single arm, open label trial for the efficacy and safety of CMAB806 in the treatment of cytokine release syndrome of novel coronavirus pneumonia (COVID-19)  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一项评估CMAB806治疗新型冠状病毒肺炎(COVID-19)患者细胞因子释放综合征的疗效和安全性的单臂、开放、多中心临床试验 

Scientific title:

A multicenter, single arm, open label trial for the efficacy and safety of CMAB806 in the treatment of cytokine release syndrome of 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:

潘英俊 

研究负责人:

彭志勇 

Applicant:

Yingjun Pan 

Study leader:

Zhiyong Peng 

申请注册联系人电话:

Applicant telephone:

+86 18686008763 

研究负责人电话:

Study leader's telephone:

+86 18672396028 

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:

panyingjun@jinyubaoling.com.cn 

研究负责人电子邮件:

Study leader's E-mail:

Pengzy5@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:

内蒙古自治区呼和浩特市经济技术开发区沙尔沁工业园区金宇大街1号 

研究负责人通讯地址:

武汉市武昌区东湖路169号 

Applicant address:

1 Jinyu Street, Sha-Er-Qin Industrial Park, Economic and Technological Development Zone, Hohhot, the Inner Mongolia Autonomous Region, China 

Study leader's address:

169 Donghu Road, Wuchang District, Wuhan, Hubei, 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:

金宇生物技术股份有限公司 

Applicant's institution:

JinYu Bio-Technology Co.,LTD. 

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:

临研伦【2020024】 

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:

武汉大学中南医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee, Central South Hospital, Wuhan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-20 

伦理委员会联系人:

郑磊 

Contact Name of the ethic committee:

Lei Zheng 

伦理委员会联系地址:

武汉市武昌区东湖路169号 

Contact Address of the ethic committee:

169 Donghu Road, Wuchang District, Wuhan, Hubei, 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:

武汉大学中南医院 

Primary sponsor:

Central South Hospital of Wuhan University 

研究实施负责(组长)单位地址:

武汉市武昌区东湖路169号 

Primary sponsor's address:

169 Donghu Road, Wuchang District, Wuhan, Hubei, 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):

内蒙古自治区

市(区县):

呼和浩特市

Country:

China

Province:

Inner Mongolia Autonomous Region

City:

Hohhot

单位(医院):

金宇生物技术股份有限公司

具体地址:

内蒙古自治区呼和浩特市经济技术开发区沙尔沁工业园区金宇大街1号

Institution
hospital:

JinYu Bio-Technology Co.,LTD.

Address:

1 Jinyu Street, Sha-Er-Qin Industrial Park, Economic and Technological Development Zone

经费或物资来源:

自筹资金 

Source(s) of funding:

funds raised by oneself 

研究疾病:

新型冠状病毒感染的肺炎患者细胞因子释放综合征 

Target disease:

cytokine release syndrome of new 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:

II期临床试验 

Study phase:

研究目的:

评价CMAB806在新型冠状病毒肺炎患者细胞因子释放综合征中的有效性和安全性; 

Objectives of Study:

To evaluate the efficacy and safety of CMAB806 in treating cytokine release syndrome of new coronavirus pneumonia (COVID-19) 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:

单臂 

Study design:

Single arm 

纳入标准:

1.受试者自愿签署知情同意书(ICF); 2.诊断为新型冠状病毒肺炎患者,且病情为普通型或重型(根据“新型冠状病毒感染的肺炎诊疗方案”),实验室检查发现IL-6显著升高(>ULN),且出现2-3级的CRS临床症状者(参考本方案表3);如出现非本方案规定的2 -3级的典型CRS,但研究者根据实验室检查结果及受试者临床症状体征判断符合CRS也可以考虑使用。 3.年龄≥18岁。  

Inclusion criteria

1. Patients volunteered to sign the informed consent; 2. Patients who were diagnosed with the common type of NCP and severe cases of new coronavirus pneumonia, Referring to the New Coronavirus Pneumonia Diagnosis and Treatment Plan, with elevation of IL-6, and grade 2-3 CRS.In the case of atypical signs of CRS, he or she should be judged by the investigator; 3. Aged >=18 years.  

排除标准:

1.存在严重的、控制不佳的伴随疾病,例如(但不限于)神经系统、心血管、肝、肾、胃肠道、内分泌疾病,并且经研究者判断可能会妨碍受试者参加本研究; 2.在筛选访视前4周内接受活疫苗/减毒疫苗的受试者或已知在观察期内会接受活疫苗/减毒疫苗的受试者; 3.对托珠单抗有过敏史者; 4.妊娠或哺乳期的女性受试者、妊娠试验阳性; 5.研究者认为不适合参加本研究的其他原因。 

Exclusion criteria:

1. People with serious or uncontrolled concomitant diseases, including sensory, vascular, heart, liver, kidney, gastric, intestinal, endocrine, etc.; 2. Having received Vaccine in the 4 weeks before entry or Planning to receive vaccine during the study; 3. Hypersensitivity to tocilizumab; 4. Pregnant or positive of the pregnancy test, lactating women; 5. Other reasons to exclude from the study.  

研究实施时间:

Study execute time:

From2020-02-20To 2020-05-31 

干预措施:

Interventions:

组别:

Case series

样本量:

60

Group:

Case series

Sample size:

干预措施:

常规治疗+托珠单抗注射液

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):

湖北 

市(区县):

 

Country:

china 

Province:

Hubei 

City:

 

单位(医院):

武汉大学中南医院 

单位级别:

三甲医院 

Institution
hospital:

Central South Hospital of Wuhan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

CRS缓解率

指标类型:

主要指标 

Outcome:

the relive of CRS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性评价指标包括AE严重不良事件(SAE),临床实验室检查(血常规、血生化、尿常规、凝血功能、心肌酶谱),临床症状,生命体征,12-导联心电图,体格检查;

指标类型:

次要指标 

Outcome:

including AE, SAE, laboratory findings, symptoms, vital signs, ECG, Physical examination.

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CRS的缓解时间

指标类型:

次要指标 

Outcome:

The time to relive

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CRS缓解后的复发率

指标类型:

次要指标 

Outcome:

The recurrence of CRS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

给药后IL-1、IL-6、IFN-γ、TNFα的变化

指标类型:

次要指标 

Outcome:

The change of IL-1, IL-6, IFN-gama, TNF-alpha

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 years
最大 Max age 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):

无随机研究

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

None randomized study

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:

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):

研究总结报告的方式

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

Modalities for the study of summary reports

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,eCollect

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-25
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