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Exploratory study for Immunoglobulin From Cured COVID-19 Patients in the Treatment of Acute Severe novel coronavirus pneuvirus (COVID-19)
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注册号:

Registration number:

ChiCTR2000030841 

最近更新日期:

Date of Last Refreshed on:

2020-03-16 

注册时间:

Date of Registration:

2020-03-15 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

应用2019新型冠状病毒肺炎(COVID-19)痊愈患者体内免疫球蛋白治疗急性重症COVID-19患者的探索性临床研究 

Public title:

Exploratory study for Immunoglobulin From Cured COVID-19 Patients in the Treatment of Acute Severe novel coronavirus pneuvirus (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

应用2019新型冠状病毒肺炎(COVID-19)痊愈患者体内免疫球蛋白治疗急性重症COVID-19患者的探索性临床研究 

Scientific title:

Treatment of Acute Severe COVID-19 With Immunoglobulin From Cured COVID-19 Patients 

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:

程翔 

研究负责人:

程翔 

Applicant:

Xiang Cheng 

Study leader:

Xiang Cheng 

申请注册联系人电话:

Applicant telephone:

+86 15972061080 

研究负责人电话:

Study leader's telephone:

+86 15972061080 

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:

nathancx@hust.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

nathancx@hust.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:

湖北省武汉市解放大道1277号 

研究负责人通讯地址:

湖北省武汉市解放大道1277号 

Applicant address:

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei, China 

Study leader's address:

1277 Jiefang Avenue, Jianghan 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:

华中科技大学同济医学院附属协和医院 

Applicant's institution:

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

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:

[2020]伦审字(0014)号 

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:

华中科技大学同济医学院附属协和医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Union hospital of Tongji Medical College, Huazhong University of Science and Technology 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-06 

伦理委员会联系人:

吴建才 

Contact Name of the ethic committee:

Jian-Cai Wu 

伦理委员会联系地址:

华中科技大学同济医学院附属协和医院药学楼6楼 

Contact Address of the ethic committee:

6th floor of pharmaceutical building, 1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei, China, 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:

华中科技大学同济医学院附属协和医院 

Primary sponsor:

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

研究实施负责(组长)单位地址:

湖北省武汉市解放大道1277号 

Primary sponsor's address:

1277 Jiefang Avenue, Jianghan 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):

武汉

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

具体地址:

湖北省武汉市解放大道1277号

Institution
hospital:

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

Address:

1277 Jiefang Avenue, Jianghan District

经费或物资来源:

华中科技大学新型冠状病毒肺炎应急科技攻关专项 

Source(s) of funding:

HUST COVID-19 Rapid Response Call 

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:

评价COVID-19痊愈患者体内免疫球蛋白治疗急性重症2019-nCoV肺炎COVID-19患者的有效性和安全性 

Objectives of Study:

To evaluate the efficacy and safety of immunoglobulin from cured COVID-19 patients in the treatment of acute severe 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:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1. 自愿参加,理解并签署知情同意书; 2. 年龄≥18岁,性别不限; 3. 确诊为急性重症2019-nCoV肺炎患者的住院患者: a.呼吸道标本或血液标本实时荧光RT-PCR检测新型冠状病毒核酸阳性, b.肺部CT符合病毒性肺炎典型改变,c.至少符合下列任何一条:呼吸窘迫,RR≥30次/分;静息状态下指氧饱和度≤93%;动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg;出现呼吸衰竭且需要机械通气;出现休克;合并其他器官功能衰竭需ICU监护治疗。 

Inclusion criteria

1. Volunteers who have understood and signed the informed consent; 2. Aged >=18 years; 3. Patients diagnosed with acute severe 2019-nCoV pneumonia: (1) Laboratory (RT-PCR) confirmed infection with 2019-nCoV. (2) Lung involvement confirmed with pulmonary CT scan; (3) At least one of the following conditions should be met: respiratory distress, RR >=30 times/min; oxygen saturation <=93% in resting state; PaO2/FiO2 <=300mmHg; respiratory failure and mechanical ventilation are required; shock occurs; ICU monitoring and treatment is required in combination with other organ failure. 

排除标准:

1. 合并除2019-nCoV以外的病毒性肺炎; 2. 患者不适合使用免疫球蛋白输注; 3. 已参与其他临床试验; 4. 研究者判断患者不适合参加该临床试验的其他情况。 

Exclusion criteria:

1. Viral pneumonia with other viruses besides 2019-nCoV; 2. Patients are not suitable for immunoglobulin therapy; 3. Participation in other studies; 4. Other circumstances in which the investigator determined that the patient is not suitable for the clinical trial. 

研究实施时间:

Study execute time:

From2020-02-17To 2020-05-31 

干预措施:

Interventions:

组别:

试验组

样本量:

5

Group:

Experimental group

Sample size:

干预措施:

痊愈者免疫球蛋白

干预措施代码:

Intervention:

Immunoglobulin of cured patients

Intervention code:

组别:

对照组

样本量:

5

Group:

Control group

Sample size:

干预措施:

丙种球蛋白

干预措施代码:

Intervention:

gama-Globulin

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):

华中科技大学同济医学院附属协和医院 

单位级别:

三甲医院 

Institution
hospital:

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

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:

Time to Clinical Improvement (TTCI)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床状态评分

指标类型:

次要指标 

Outcome:

Clinical status assessed by the ordinal scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

给氧方式的差异

指标类型:

次要指标 

Outcome:

The differences in oxygen intake methods

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

氧疗持续时间

指标类型:

次要指标 

Outcome:

Duration (days) of supplemental oxygenation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

机械通气持续时间

指标类型:

次要指标 

Outcome:

Duration (days) of mechanical 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:

平均氧合指数

指标类型:

次要指标 

Outcome:

The mean PaO2/FiO2

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺段累及数量

指标类型:

次要指标 

Outcome:

The lesions of the pulmonary segment numbers involved in pulmonary CT

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

核酸转阴时间

指标类型:

次要指标 

Outcome:

Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗体滴度动态变化

指标类型:

次要指标 

Outcome:

Dynamic changes of 2019-nCoV antibody titer in blood

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:

Length of hospital stay (days)

Type:

Secondary 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

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:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

None

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 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):

非随机对照研究

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

Non-randomized control

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:

Within six months after the trial complete

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):

Revman

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

Revman

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:

Revman

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

Revman

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-15
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