Today is 2020-10-31

A clinical study for the efficacy and safety of Adalimumab Injection in the treatment of patients with severe novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030089 

最近更新日期:

Date of Last Refreshed on:

2020-02-23 

注册时间:

Date of Registration:

2020-02-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

格乐立(阿达木单抗)治疗新型冠状病毒肺炎(COVID-19)重型和危重型患者的安全性和有效性的临床研究 

Public title:

A clinical study for the efficacy and safety of Adalimumab Injection in the treatment of patients with severe novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一项评价阿达木单抗治疗新型冠状病毒肺炎(COVID-19)重型和危重型患者的安全性和有效性的临床研究 

Scientific title:

A randomized, open-label, controlled trial for the efficacy and safety of Adalimumab Injection in the treatment of patients with severe 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:

周凌 

研究负责人:

徐沪济 

Applicant:

Ling Zhou 

Study leader:

Huji Xu 

申请注册联系人电话:

Applicant telephone:

+86 13651602804 

研究负责人电话:

Study leader's telephone:

+86 13671609764 

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:

doczhouling@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xuhuji@smmu.edu.cn 

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:

上海市黄浦区凤阳路415号 

研究负责人通讯地址:

上海市黄浦区凤阳路415号 

Applicant address:

415 Fengyang Road, Huangpu District, Shanghai, China 

Study leader's address:

415 Fengyang Road, Huangpu 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:

上海长征医院 

Applicant's institution:

Shanghai Changzheng 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:

2020SL004 

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:

上海长征医院生物医学研究伦理委员会 

Name of the ethic committee:

Biomedical research ethics committee of Shanghai Changzheng Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-22 

伦理委员会联系人:

孙吕平 

Contact Name of the ethic committee:

Lvping Sun 

伦理委员会联系地址:

上海市黄浦区凤阳路415号 

Contact Address of the ethic committee:

415 Fengyang Road, Huangpu District, Shanghai, 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:

上海长征医院 

Primary sponsor:

Shanghai Changzheng Hospital 

研究实施负责(组长)单位地址:

上海市黄浦区凤阳路415号 

Primary sponsor's address:

415 Fengyang Road, Huangpu 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):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海长征医院

具体地址:

上海市黄浦区凤阳路415号

Institution
hospital:

Shanghai Changzheng Hospital

Address:

415 Fengyang Road, Huangpu District, Shanghai, China

经费或物资来源:

上海长征医院课题和百奥泰生物制药股份有限公司捐赠药物 

Source(s) of funding:

Shanghai Changzheng Hospital Project Fund and Drug donation from Bio-Thera Solutions, Ltd. 

研究疾病:

新型冠状病毒肺炎 

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:

比较在标准化治疗基础上,观察加/不加阿达木单抗治疗重型以及危重型2019新型冠状病毒(COVID-19)肺炎的临床疗效和安全性 

Objectives of Study:

The clinical efficacy and safety with and without the addition of Adalimumab Injection to conventional treatment of severe and critical 2019 novel coronavirus (COVID-19) pneumonia will be compared on the basis of conventional 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:

符合下列条件者方可成为本研究的受试者: 1.签署书面知情同意。 2.年龄≥18 岁 3.符合NCP重症和危重症诊断标准,即《新型冠状病毒感染的肺炎诊疗方案(试行第六版)》。结合流行病学史、临床表现和病原学检查综合判断。 4.病程在起病后14天内。 5.愿意进行给药前鼻咽或口咽拭子采集。 

Inclusion criteria

Subjects who meet the following conditions can become subjects of this study: 1. Will sign written informed consent. Adolescents or patients who cannot sign informed consent must obtain informed consent from the guardian; 2. Chinese aged >=18 years; 3. In accordance with NCP criteria for severe and critical illness, namely "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)". Combined with the following epidemiological history, clinical manifestations, and pathogenic examinations to make a comprehensive judgment. 4. The course of disease is within 14 days after the onset of illness; 5. Will take nasopharyngeal or oropharyngeal swabs before administration. 

排除标准:

具有以下任何一项的患者不能入组本研究: 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,或中性粒细胞<0.5??109/L,或血小板小于50??109/L; 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.对阿达木单抗单抗或任何辅料发生超敏反应者; 8.肺结核患者; 

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. Expected survival is less than 1 week; 5. Patients diagnosed with rheumatic immune related diseases; 6. Take orally anti rejection drugs or immunomodulatory drugs for a long time; 7. Hypersensitive to adalimumab or any excipients; 8. Patients with active pulmonary tuberculosis, with definite bacterial and fungal infections 

研究实施时间:

Study execute time:

From2020-02-28To 2020-08-31 

征募观察对象时间:

Recruiting time:

From2020-02-28To 2020-08-31 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

Experimental group

Sample size:

干预措施:

常规治疗+阿达木治疗

干预措施代码:

Intervention:

Conventional treatent and adalimumab

Intervention code:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

conventional treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海长征医院 

单位级别:

三级甲等 

Institution
hospital:

shanghai changzhen hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

临床改善时间

指标类型:

主要指标 

Outcome:

TTCI (Time to Clinical Improvement)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全因死亡率

指标类型:

次要指标 

Outcome:

All-cause 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:

体温恢复时间

指标类型:

次要指标 

Outcome:

Time for body temperature to return to normal

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸道症状改善时间

指标类型:

次要指标 

Outcome:

Time of improvement in respiratory symptoms

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

重型及危重型转为轻型的比例

指标类型:

次要指标 

Outcome:

Proportion of severe to light

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院天数

指标类型:

次要指标 

Outcome:

Days in hospital

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无创/有创通气的持续时间

指标类型:

次要指标 

Outcome:

Duration of non-invasive / invasive ventilation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

严重不良事件的发生频率

指标类型:

次要指标 

Outcome:

Frequency of serious 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:

炎症因子

指标类型:

次要指标 

Outcome:

inflammatory factors

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:

标本中文名:

尿液

组织:

Sample Name:

Urine

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:

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):

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

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):

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 paper

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:

有/Yes

注册人:

Name of Registration:

 2020-02-22
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