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Multicenter randomized controlled trial for rhG-CSF in the treatment of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030007 

最近更新日期:

Date of Last Refreshed on:

2020-02-28 

注册时间:

Date of Registration:

2020-02-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

重组人粒细胞集落刺激因子治疗新型冠状病毒肺炎(COVID-19)的多中心临床随机对照研究 

Public title:

Multicenter randomized controlled trial for rhG-CSF 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:

重组人粒细胞集落刺激因子治疗新型冠状病毒肺炎(COVID-19)的多中心临床随机对照研究 

Scientific title:

Multicenter randomized controlled trial for rhG-CSF 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:

程璘令 

研究负责人:

钟南山 

Applicant:

Linling Cheng 

Study leader:

Nanshan Zhong 

申请注册联系人电话:

Applicant telephone:

+86 13902233092 

研究负责人电话:

Study leader's telephone:

+86 13902233092 

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:

linling@gird.cn 

研究负责人电子邮件:

Study leader's E-mail:

linling@gird.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:

广州市越秀区沿江路151号 

研究负责人通讯地址:

广州市越秀区沿江路151号 

Applicant address:

151 Yanjiang Road, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

151 Yanjiang Road, Yuexiu District, Guangzhou 

申请注册联系人邮政编码:

Applicant postcode:

510120 

研究负责人邮政编码:

Study leader's postcode:

510120 

申请人所在单位:

广州医科大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Guangzhou Medical University 

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:

医研伦审2020第48号 

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:

广州医科大学附属第一医院临床试验伦理委员会 

Name of the ethic committee:

Clinical Trial Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-17 

伦理委员会联系人:

余达加 

Contact Name of the ethic committee:

Dajia Yu 

伦理委员会联系地址:

广州市越秀区沿江路151号 

Contact Address of the ethic committee:

151 Yanjiang Road, Yuexiu District, Guangzhou, Guangdong, 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:

广州医科大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Guangzhou Medical University 

研究实施负责(组长)单位地址:

广州市越秀区沿江路151号 

Primary sponsor's address:

151 Yanjiang Road, Yuexiu District, Guangzhou, Guangdong, 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州医科大学附属第一医院

具体地址:

越秀区沿江路151号

Institution
hospital:

The First Affiliated Hospital of Guangzhou Medical University

Address:

151 Yanjiang Road, Yuexiu District

经费或物资来源:

自筹 

Source(s) of funding:

Self financing 

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:

研究重组人粒细胞集落刺激因子治疗新型冠状病毒肺炎(COVID-19)的有效性和安全性。 

Objectives of Study:

To investigate the efficacy and safety of rhG-CSF in the treatment of novel coronavirus pneumonia (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:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 新冠肺炎轻型、普通型和重型确诊病例,年龄15-80岁。参照新型冠状病毒性肺炎诊断标准符合国家卫健委颁发的关于印发新型冠状病毒感染的肺炎诊疗方案(试行第五版) 的诊断标准。 2. 外周血白细胞计数<15×10^9/L和淋巴细胞<0.8×10^9/L。 

Inclusion criteria

1. Patients aged 15-80 years,diagnosed with mild, common, and severe novel coronavirus pneumonia in accordance with the diagnostic criteria for the diagnosis and treatment of novel coronavirus pneumonia issued by the National Health Commission (trial version 5); 2. White blood cell Count < 15.0 x 10^9/L and Lymphocyte Count < 0.8 x10^9/L. 

排除标准:

1. 合并高血压、糖尿病、冠心病等基础疾病; 2. 合并恶性肿瘤或有恶性肿瘤病史; 3. 妊娠或哺乳期妇女; 4. 患有严重精神疾病; 5. 6个月内有不稳定性心绞痛或心肌梗塞史,冠状动脉造影;提示冠状动脉主 要分支重度狭窄; 6. 6个月内有脑梗塞或脑出血病史; 7. 对重组人粒细胞集落刺激因子不耐受或过敏者; 8. 经研究者判断患者不适宜纳入试验。 

Exclusion criteria:

1. Combining basic diseases such as hypertension, diabetes, and coronary heart disease; 2. Malignant tumor or with a history of malignant tumor; 3. pregnant or lactating women; 4. suffer from severe mental illness; 5. History of unstable angina pectoris or myocardial infarction within 6 months; coronary angiography suggested severe stenosis of the main branches of the coronary arteries; 6. History of cerebral infarction or cerebral hemorrhage within 6 months; 7. People who are intolerant or allergic to rhG-CSF; 8. Patients were judged unsuitable for inclusion in the trial. 

研究实施时间:

Study execute time:

From2020-02-03To 2020-04-10 

征募观察对象时间:

Recruiting time:

From2020-02-03To 2020-04-10 

干预措施:

Interventions:

组别:

试验组

样本量:

100

Group:

Experimental group

Sample size:

干预措施:

重组人粒细胞集落刺激因子,5ug/kg,和常规治疗

干预措施代码:

Intervention:

rhG-CSF, 5ug/kg, combinated with standard treatment

Intervention code:

组别:

对照组

样本量:

100

Group:

Control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

standard treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Guangzhou Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州市第八人民医院 

单位级别:

三级 

Institution
hospital:

Guangzhou Eighth People's Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

武汉市 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学同济医学院附属协和医院 

单位级别:

三甲 

Institution
hospital:

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

武汉市 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉市汉口医院 

单位级别:

三级 

Institution
hospital:

Wuhan Hankou Hospital  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

胸部CT

指标类型:

主要指标 

Outcome:

Chest CT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床症状

指标类型:

主要指标 

Outcome:

Clinical symptoms

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

主要指标 

Outcome:

Blood routine

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咽拭子2019-nCOV病毒载量

指标类型:

主要指标 

Outcome:

the viral load of 2019-nCOV of throat swab

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

TBNK细胞亚群

指标类型:

主要指标 

Outcome:

TBNK cell subsets

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

TH1/TH2细胞因子

指标类型:

主要指标 

Outcome:

TH1/TH2 Cytokine

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:

咽拭子

组织:

Sample Name:

Throat swab

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 15 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):

患者由申办者随机编码,随机分配至试验组或对照组。随机编码在 SAS 9.2 软件中使用分层法生成。

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

Patients were randomly coded by the sponsor, and were distributed to experimental or control groups randomly. The random code is generated in SAS 9.2 software by layered method.

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):

可通过邮件联系项目负责人,进行数据获取。

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

Data can be obtained by contacting the PI through email.

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:

使用 CRF 表采集数据,数据以 Excel 格式保存。

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

Datas are collected by CRF and stored as Excel files.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-19
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