Today is 2020-09-23

Clinical study for infusing convalescent plasma to treat patients with new coronavirus pneumonia (COVID-19)
download

注册号:

Registration number:

ChiCTR2000030039 

最近更新日期:

Date of Last Refreshed on:

2020-02-21 

注册时间:

Date of Registration:

2020-02-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

输注康复者恢复期血浆治疗新型冠状病毒肺炎(COVID-19)患者的临床研究 

Public title:

Clinical study for infusing convalescent plasma to treat patients with new coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

输注康复者恢复期血浆治疗新型冠状病毒肺炎(COVID-19)患者的临床研究 

Scientific title:

Clinical study for infusing convalescent plasma to treat patients with new 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:

汪莉萍 

研究负责人:

颜学兵 

Applicant:

Liping Wang 

Study leader:

Xuebing Yan 

申请注册联系人电话:

Applicant telephone:

+86 18052268126 

研究负责人电话:

Study leader's telephone:

+86 15205215685 

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:

163wangliping@163.com 

研究负责人电子邮件:

Study leader's E-mail:

yxbxuzhou@126.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:

江苏省徐州市鼓楼区鲲鹏路9号 

研究负责人通讯地址:

江苏省徐州市鼓楼区鲲鹏路9号 

Applicant address:

9 Kunpeng Road, Gulou District, Xuzhou, Jiangsu, China 

Study leader's address:

9 Kunpeng Road, Gulou District, Xuzhou, Jiangsu, 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:

徐州医科大学附属医院 

Applicant's institution:

Affiliated Hospital of Xuzhou 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:

XYFY2020-KL002-01 

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:

徐州医科大学附属医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of the Affiliated Hospital of Xuzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-13 

伦理委员会联系人:

翟凤平 

Contact Name of the ethic committee:

Fengping Zhai 

伦理委员会联系地址:

江苏省徐州市鼓楼区淮海西路99号 

Contact Address of the ethic committee:

99 Huaihai Road West, Gulou District, Xuzhou, Jiangsu, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0516 85802291 

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:

徐州医科大学附属医院 

Primary sponsor:

Affiliated Hospital of Xuzhou Medical University 

研究实施负责(组长)单位地址:

江苏省徐州市鼓楼区鲲鹏路9号 

Primary sponsor's address:

9 Kunpeng Road, Gulou District, Xuzhou, Jiangsu, 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):

江苏

市(区县):

徐州

Country:

China

Province:

Jiangsu

City:

Xuzhou

单位(医院):

徐州医科大学附属医院

具体地址:

江苏省徐州市泉山区淮海西路99号

Institution
hospital:

Affiliated Hospital of Xuzhou Medical University

Address:

99 huaihai west road, gulou district, xuzhou city, jiangsu province, China

经费或物资来源:

本单位 

Source(s) of funding:

the working unit 

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:

其它 

Study phase:

N/A 

研究目的:

评价输注康复者恢复期血浆治疗新型冠状病毒肺炎患者的安全性及有效性 

Objectives of Study:

To evaluate the safety and effectiveness of infusing convalescent plasma for treatment of patients with novel coronavirus pneumonia 

药物成份或治疗方案详述:

新型冠状病毒康复者恢复期血浆 

Description for medicine or protocol of treatment in detail:

Plasma in convalescent patients with novel coronavirus 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1.诊断符合《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》诊断标准; 2.临床分型为普通型,重型或危重型; 3.受试者年龄≥18周岁患者; 4.患者或其法定监护人自愿参加并签署知情同意书。 

Inclusion criteria

1. The diagnosis conforms to the diagnostic criteria of "pneumonia diagnosis and treatment program for new coronavirus infection (trial version 5)"; 2. Clinical classification is normal,severe or critical; 3. Subject aged >=18 years old; 4. The patient or his/her legal guardian will participate voluntarily and sign the informed consent. 

排除标准:

1.高度过敏体质或有严重过敏史,尤其血浆过敏者; 2.医生认为还存在有其他原因不能纳入治疗者。 

Exclusion criteria:

1. Highly allergic constitution or history of severe allergy, especially plasma allergy; 2. The doctor believes that there are other reasons not to include the healer. 

研究实施时间:

Study execute time:

From2020-02-01To 2020-02-01 

征募观察对象时间:

Recruiting time:

From2020-05-31To 2020-05-31 

干预措施:

Interventions:

组别:

实验组

样本量:

30

Group:

Experimental group

Sample size:

干预措施:

常规治疗并输注同型康复期血浆:200-500ml 建议分两次输注

干预措施代码:

Intervention:

conventional therapy with Infusion of convalescent plasma: 200-500ml, two infusions are recommended

Intervention code:

组别:

对照组

样本量:

60

Group:

control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

conventional therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

徐州 

Country:

China 

Province:

Jiangsu 

City:

Xuzhou 

单位(医院):

徐州医科大学附属医院 

单位级别:

三甲医院 

Institution
hospital:

Affiliated Hospital of Xuzhou Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

徐州 

Country:

China 

Province:

Jiangsu 

City:

Xuzhou 

单位(医院):

徐州市传染病院 

单位级别:

三乙医院 

Institution
hospital:

Xuzhou Infectious Disease Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

连云港 

Country:

China 

Province:

Jiangsu 

City:

Lianyungang 

单位(医院):

连云港第四人民医院 

单位级别:

三级医院 

Institution
hospital:

The Fourth People's Hospital of Lianyungang  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

宿迁 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

宿迁市第一人民医院 

单位级别:

三级医院 

Institution
hospital:

Suqian First Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

盐城 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

盐城市第二人民医院 

单位级别:

三级医院 

Institution
hospital:

Yancheng Second People's Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

宿迁 

Country:

China 

Province:

Jiangsu 

City:

Suqian 

单位(医院):

宿迁市传染病院 

单位级别:

二甲医院 

Institution
hospital:

Suqian Infectious Disease Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

苏州 

Country:

China 

Province:

Jiangsu 

City:

Suzhou 

单位(医院):

苏州市第五人民医院 

单位级别:

三级医院 

Institution
hospital:

Suzhou Fifth People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

常州 

Country:

China 

Province:

Jiangsu 

City:

Changzhou 

单位(医院):

常州市第三人民医院 

单位级别:

三级医院 

Institution
hospital:

Changzhou Third People's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

SARS-CoV-2 病毒量

指标类型:

主要指标 

Outcome:

SARS-CoV-2 DNA

Type:

Primary indicator 

测量时间点:

入院当日,后根据患者病情而定

测量方法:

Measure time point of outcome:

Infusion day1 and recheck according to the patient's condition

Measure method:

指标中文名:

SARS-CoV-2抗体水平

指标类型:

主要指标 

Outcome:

SARS-CoV-2 antibody levels

Type:

Primary indicator 

测量时间点:

入院当日,后根据患者病情而定

测量方法:

Measure time point of outcome:

Infusion day1 and recheck according to the patient's condition

Measure method:

指标中文名:

C反应蛋白

指标类型:

次要指标 

Outcome:

CRP

Type:

Secondary indicator 

测量时间点:

入院当日,第3日,第7日,第10日,第14日,输注当日、第2日,出院后14天

测量方法:

Measure time point of outcome:

Hospitalized day1, day 3, day 7, day 14, Infusion day1, day 2, 14 days after discharge

Measure method:

指标中文名:

白介素-6

指标类型:

次要指标 

Outcome:

IL-6

Type:

Secondary indicator 

测量时间点:

入院当日,第3日,第7日,第10日,第14日,输注当日、第2日,出院后14天

测量方法:

Measure time point of outcome:

Hospitalized day1, day 3, day 7, day 14, Infusion day1, day 2, 14 days after discharge

Measure method:

指标中文名:

乳酸脱氢酶

指标类型:

次要指标 

Outcome:

LDH

Type:

Secondary indicator 

测量时间点:

入院当日,第3日,第7日,第10日,第14日,输注当日、第2日,出院后14天

测量方法:

Measure time point of outcome:

Hospitalized day1, day 3, day 7, day 14, Infusion day1, day 2, 14 days after discharge

Measure method:

指标中文名:

肌酸激酶

指标类型:

次要指标 

Outcome:

CK

Type:

Secondary indicator 

测量时间点:

入院当日,第3日,第7日,第10日,第14日,输注当日、第2日,出院后14天

测量方法:

Measure time point of outcome:

Hospitalized day1, day 3, day 7, day 14, Infusion day1, day 2, 14 days after discharge

Measure method:

指标中文名:

肝功能

指标类型:

次要指标 

Outcome:

liver function

Type:

Secondary indicator 

测量时间点:

入院当日,第3日,第7日,第10日,第14日,输注当日、第2日,出院后14天

测量方法:

Measure time point of outcome:

Hospitalized day1, day 3, day 7, day 14, Infusion day1, day 2, 14 days after discharge

Measure method:

指标中文名:

肾功能

指标类型:

次要指标 

Outcome:

runal function

Type:

Secondary indicator 

测量时间点:

入院当日,第3日,第7日,第10日,第14日,输注当日、第2日,出院后14天

测量方法:

Measure time point of outcome:

Hospitalized day1, day 3, day 7, day 14, Infusion day1, day 2, 14 days after discharge

Measure method:

指标中文名:

呼吸频率

指标类型:

次要指标 

Outcome:

respiratory rate

Type:

Secondary indicator 

测量时间点:

入院当日,第3日,第7日,第10日,第14日,输注当日、第2日,出院后14天

测量方法:

Measure time point of outcome:

Hospitalized day1, day 3, day 7, day 14, Infusion day1, day 2, 14 days after discharge

Measure method:

指标中文名:

氧合指数

指标类型:

次要指标 

Outcome:

SiO2

Type:

Secondary indicator 

测量时间点:

入院当日,第3日,第7日,第10日,第14日,输注当日、第2日,出院后14天

测量方法:

Measure time point of outcome:

Hospitalized day1, day 3, day 7, day 14, Infusion day1, day 2, 14 days after discharge

Measure method:

指标中文名:

胸部螺旋CT

指标类型:

主要指标 

Outcome:

thoracic spiral CT

Type:

Primary indicator 

测量时间点:

后根据患者病情而定复查,出院后14天

测量方法:

Measure time point of outcome:

Hospitalized day1, day 3, day 7, day 14, Infusion day1, echeck according to the patient's condition,14 days after discharge

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 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):

入组前,研究者再次核对入选及排除标准确认受试者是否入组。

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

Prior to enrollment, the researchers rechecked the selection and exclusion criteria to determine if the subjects were enrolled.

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:

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):

本研究将以CAP-China研究者的名义开展。中心项目协调和数据管理将由徐州医科大学提供。本研究的主要出版物将采用CAP-China研究者的姓名,并向所有协调研究者、研究协调员和机构分配完整的信用凭证。

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

This study will be conducted on behalf of CAP-China researchers. The central project coordination and data management will be provided by Xuzhou Medical University.

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:

将由各研究中心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,并与经验证数据系统中的其他来源提供的数据合并。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 in each research centre. 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 and merged with data from other sources in the validated data system. 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.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-21
return list