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Efficacy and safety of tozumab combined with adamumab(Qletli) in severe and critical patients with novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030580 

最近更新日期:

Date of Last Refreshed on:

2020-03-15 

注册时间:

Date of Registration:

2020-03-08 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

托珠单抗联合阿达木单抗(格乐立)在新型冠状病毒肺炎(COVID-19)重症和危重症患者的有效性及安全性研究 

Public title:

Efficacy and safety of tozumab combined with adamumab(Qletli) in severe and critical 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:

托珠单抗联合阿达木单抗(格乐立)治疗重症和危重症新型冠状病毒肺炎(COVID-19)的前瞻性、单中心、随机、平行对照的临床研究 

Scientific title:

Tozumab combined with adamumab(Qletli) in the treatment of severe and critically ill patients with novel coronavirus pneumonia (COVID-19):A prospective, single-center, randomized, parallel controlled trial  

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:

包爱华 

研究负责人:

张旻 

Applicant:

Aihua Bao 

Study leader:

Min Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13402016536 

研究负责人电话:

Study leader's telephone:

+86 18121288279 

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:

aihuabao312@126.com 

研究负责人电子邮件:

Study leader's E-mail:

maggie_zhangmin@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:

上海市武进路85号 

研究负责人通讯地址:

上海市武进路85号 

Applicant address:

NO.85 Wujin Road, Hongkou District, Shanghai, China 

Study leader's address:

NO.85 Wujin Road, Hongkou District, Shanghai, 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:

上海市第一人民医院 

Applicant's institution:

Shanghai General 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:

院伦审[2019]15 

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:

上海市第一人民医院伦理委员会 

Name of the ethic committee:

The Ethic Committee of Shanghai General Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-07 

伦理委员会联系人:

上海市第一人民医院伦理委员会 

Contact Name of the ethic committee:

The Ethic Committee of Shanghai General Hospital 

伦理委员会联系地址:

上海市武进路85号 

Contact Address of the ethic committee:

85 Wujin Road, Hongkou District, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021-63240090 

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:

上海市第一人民医院 

Primary sponsor:

Shanghai General Hospital 

研究实施负责(组长)单位地址:

上海市武进路85号 

Primary sponsor's address:

85 Wujin Road, Hongkou District, Shanghai, 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):

上海

市(区县):

虹口

Country:

China

Province:

Shanghai

City:

Hongkou District

单位(医院):

上海市第一人民医院

具体地址:

武进路85号

Institution
hospital:

Shanghai General Hospital

Address:

85 Wujin Road

经费或物资来源:

浙江大学新型冠状病毒肺炎(COVID-19)应急科研专项资金资助 

Source(s) of funding:

supported by Zhejiang University special scientific research fund for COVID-19 prevention and control 

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:

上市后药物 

Study phase:

研究目的:

评估在标准治疗基础上联合应用托珠单抗和阿达木单抗治疗重症和危重症新型冠状病毒肺炎的安全性及有效性。 

Objectives of Study:

To evaluate the safety and efficacy of combination of tozumab and adamumab in the treatment of severe and critical novel coronavirus pneumonia on the basis of standard treatment. 

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18-80周岁; (2)确诊的新型冠状病毒肺炎的重型(含危重症高危因素)、危重型患者; (3)血CRP、ESR较正常值升高两倍以上或TNFα和IL-6较正常值升高的患者; (4)签署知情同意书。 

Inclusion criteria

(1) aged 18-80 years old; (2) severe (including critical risk factors) and critical patients with confirmed novel coronavirus pneumonia; (3) blood CRP and ESR were more than twice higher than normal or TNFα and Il-6 were higher than normal; (4) sign the informed consent. 

排除标准:

(1)孕妇或哺乳期的女性; (2)ALT/AST>5倍ULN,中性粒细胞<0.5×109/L,血小板小于50×109/L; (3) 明确诊断有风湿免疫、 恶性肿瘤等相关疾病; (4)长期口服免疫调节药物或14天内曾使用大剂量糖皮质激素患者; (5)对阿达木单抗或托珠单抗发生过敏反应者; (6)活动性肝炎、结核,合并有明确的严重细菌感染和真菌感染,器官移植或精神障碍患者; (7)14天内已经用过IL-6单抗或TNFα单抗的患者; 

Exclusion criteria:

(1) pregnant or breast-feeding women; (2) ALT/AST > 5 times ULN, neutrophils < 0.5x10^9/L, platelets less than 50x10^9/L; (3) definite diagnosis of rheumatoid immunity, malignant tumor and other related diseases; (4) patients with long-term oral immunoregulatory drugs or who had used large doses of glucocorticoids within 14 days; (5) allergic reactions to adamumab or tozumab; (6) active hepatitis, tuberculosis, associated with specific severe bacterial and fungal infections, organ transplantation or mental disorders; (7) received Il-6 monoclonal antibody or TNFα monoclonal antibody within 14 days. 

研究实施时间:

Study execute time:

From2020-02-01To 2020-04-30 

征募观察对象时间:

Recruiting time:

From2020-02-01To 2020-03-31 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

experimental group

Sample size:

干预措施:

按照指南推荐的标准治疗基础上,联合使用托珠单抗及阿达木单抗

干预措施代码:

Intervention:

Based on the standard treatment recommended in the guidelines, a combination of tozumab and adamumab was used

Intervention code:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

按照指南推荐的标准治疗

干预措施代码:

Intervention:

Follow the guidelines for standard treatment

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):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉雷神山医院 

单位级别:

 

Institution
hospital:

Wuhan Leishenshan Hospital  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

胸部CT

指标类型:

主要指标 

Outcome:

chest computerized tomography

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新型冠状病毒核酸检测

指标类型:

主要指标 

Outcome:

Nucleic acid detection of novel coronavirus

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤坏死因子α

指标类型:

主要指标 

Outcome:

TNF-alpha

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白介素6

指标类型:

主要指标 

Outcome:

IL-6

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白介素10

指标类型:

主要指标 

Outcome:

IL-10

Type:

Primary 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:

标本中文名:

尿液

组织:

Sample Name:

urea

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 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):

电脑随机数表法

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

Computer random number

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

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):

试验完成后6个月内公开

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

Within six months after the trial complete

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:

Case Record Form, CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-08
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