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Clinical Trial for Recombinant Human Interleukin-2 in the Treatment of Novel Coronavirus Pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030167 

最近更新日期:

Date of Last Refreshed on:

2020-02-24 

注册时间:

Date of Registration:

2020-02-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

该研究尚未获得伦理委员会批准。请于批准后才开始纳入参试者,并与我们联系上传批件 重组人白介素2治疗新型冠状病毒(COVID-19)肺炎的临床研究 

Public title:

Clinical Trial for Recombinant Human Interleukin-2 in the Treatment 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:

重组人白介素2治疗新型冠状病毒(COVID-19)肺炎的临床研究 

Scientific title:

Clinical Trial for Recombinant Human Interleukin-2 in the Treatment 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:

蔡林志 

研究负责人:

陈谦学 

Applicant:

Linzhi Cai 

Study leader:

Qianxue Chen 

申请注册联系人电话:

Applicant telephone:

+86 15071128925 

研究负责人电话:

Study leader's telephone:

+86 027-88041911-82237 

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:

cailinzhi@yahoo.com 

研究负责人电子邮件:

Study leader's E-mail:

chenqx666@whu.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:

中国湖北省武汉市武昌区解放路99号 

研究负责人通讯地址:

中国湖北省武汉市武昌区解放路99号 

Applicant address:

99 Jiefang Road, Wuchang District, Wuhan, Hubei, China 

Study leader's address:

99 Jiefang 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:

武汉大学人民医院 

Applicant's institution:

Renmin Hospital of Wuhan 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:

武汉大学人民医院 

Primary sponsor:

Renmin Hospital of Wuhan University 

研究实施负责(组长)单位地址:

中国湖北省武汉市武昌区解放路99号 

Primary sponsor's address:

99 Jiefang 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):

湖北

市(区县):

Country:

China

Province:

Hubei

City:

单位(医院):

武汉大学人民医院

具体地址:

中国湖北省武汉市武昌区解放路99号

Institution
hospital:

Renmin Hospital of Wuhan University

Address:

99 Jiefang Road, Wuchang District, Wuhan

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(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:

探索性研究/预试验 

Study phase:

研究目的:

1,评估重组人白细胞介素2治疗新冠肺炎的疗效。 2,收集临床医学资料,研究新冠肺炎患者细胞免疫功能改变。 

Objectives of Study:

1. To evaluate the clinical efficacy of Recombinant Human Interleukin-2 in the treatment of pneumonitis caused by new coronavirus; 2. To collect clinical immunological datas of patients with novel coronavirus pneumoina for further study. 

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) 符合新型冠状病毒肺炎诊断,且临床分型为轻型和普通型者; (2) 年龄在18~75周岁的住院病人,男女不限; (3) 自愿接受该药治疗,并签署知情同意书。知情同意过程符合GCP有关规定。 

Inclusion criteria

(1) Those who meet the diagnosis of new coronavirus pneumonia and have clinical classification of low and medium; (2) Inpatients aged 18 to 75 years; (3) Voluntarily receive treatment with the drug and sign informed consent. The informed consent process complies with relevant GCP regulations.  

排除标准:

(1) 免疫缺陷疾病,或近3个月内使用免疫抑制剂或糖皮质激素者。 (2) 准备妊娠者、孕妇及哺乳期妇女。 (3) 过敏体质者(指对两种以上的药品或食品过敏或本次试验用药已知成份过敏)。 (4) 精神病患者,或无自知能力者。 (5) 从筛选开始预计生存时间不超过48小时的患者。 (6) 筛选时已经气管插管或机械通气者。 (7) 心、肝、肾或其他各种系统明显症状,ALT、AST超过正常值上限的1.5倍。 (8) 研究者认为有不适宜参加临床试验者。  

Exclusion criteria:

(1) Immunodeficiency disease, or those who have used immunosuppressive agents or glucocorticoids within the past 3 months; (2) Preparing pregnant, pregnant and lactating women; (3) Patients with allergies (referring to allergies to two or more medicines, foods or known ingredients in this study); (4) Patients with mental illness, or have no cognitive ability; (5) Patients with an estimated survival time of less than 48 hours from the start of screening; (6) Those who have been intubated or mechanically ventilated at the time of screening; (7) Obvious symptoms of heart, liver, kidney or various other systems, ALT, AST exceed 1.5 times the upper limit of normal value; (8) Believed to be not suitable to participate in clinical trials by investigator.  

研究实施时间:

Study execute time:

From2020-03-02To 2020-09-01 

征募观察对象时间:

Recruiting time:

From2020-03-02To 2020-05-02 

干预措施:

Interventions:

组别:

实验组

样本量:

40

Group:

Experimental Group

Sample size:

干预措施:

常规治疗+肌肉注射小剂量重组人白介素2(100万IU/次,每间隔一天一次,一周三次,连续2周)

干预措施代码:

Intervention:

Conventional Treatment & Low Dose Recombinant Human Interleukin-2, i.m.(1 million IU per time, once another day, 3 times per week, 2 weeks)

Intervention code:

组别:

对照组

样本量:

40

Group:

Control Group

Sample size:

干预措施:

常规治疗+肌肉注射生理盐水(每间隔一天一次,一周三次,连续2周)

干预措施代码:

Intervention:

Conventional Treatment+Placebo i.m.(once another day, 3 times per week, 2 weeks)

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):

武汉大学人民医院 

单位级别:

三甲医院 

Institution
hospital:

Renmin Hospital of Wuhan University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

CD8+ T 细胞数

指标类型:

主要指标 

Outcome:

CD8+ T cells numbers

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD4+ T 细胞数

指标类型:

主要指标 

Outcome:

CD4+ T cell numbers

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NK cell numbers

指标类型:

主要指标 

Outcome:

NK cell numbers

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:

主要指标 

Outcome:

Fatality 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:

指氧饱和度

指标类型:

次要指标 

Outcome:

Arterial Oxygen Saturation

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:

cytokines/chemokines

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

次要指标 

Outcome:

Hospital stay duration

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床痊愈时间

指标类型:

主要指标 

Outcome:

Clinical recovery 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:

炎症指标(CRP)

指标类型:

次要指标 

Outcome:

Inflammation index (CRP)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

重症(重型或危重型)转化率

指标类型:

主要指标 

Outcome:

Critical (severe or critical) conversion rate

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:

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 18 years
最大 Max age 75 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):

采用区组随机化方法。运用专业统计软件分别产生2组共72例受试者所接受处理(试验组和对照组)的随机表,即流水号为001~080所对应的治疗分配表。

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

Block randomization method will be used. The professional statistical software will be used to generate a random list of treatments (treatment group and control group) for a total of 20 subjects, that is, the treatment allocation table corresponding to the serial number 001-020.

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):

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):

相关网站或文章

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

Related websites and articles

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:

将由接受过培训的工作人员采集所有数据。然后将数据填写在设计的病例报告表(CRF)中,定期由项目组成员录入电子数据库中。研究者负责确保录入采集数据的完整、准确与及时记录。然后由项目组对病历中的数据进行审查。按照适用的标准和数据清理程序进行临床数据管理,以确保数据的完整性。

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

All data will be collected by staff trained. The data is then filled in a designed case report form (CRF), which is regularly entered by the project team members into an electronic database . The investigator is responsible for ensuring that the data entered is complete, accurate, and timely. The project team then reviews the data in the medical records. Manage clinical data in accordance with applicable standards and data cleaning procedures to ensure data integrity.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-24
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