Today is 2020-07-14

Study on convalescent plasma treatment for severe patients with novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000029850 

最近更新日期:

Date of Last Refreshed on:

2020-02-15 

注册时间:

Date of Registration:

2020-02-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型冠状病毒肺炎 (COVID-19) 重症患者免疫血清治疗的临床研究 

Public title:

Study on convalescent plasma treatment for severe patients with novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评估新型冠状病毒肺炎(COVID-19) 重症患者应用免疫血清治疗的安全性及有效性的前瞻性队列研究 

Scientific title:

Effecacy and safty of convalescent plasma treatment for severe patients with novel coronavirus pneumonia (COVID-19): a prospective cohort study 

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:

俞亮 

研究负责人:

徐小微 

Applicant:

Liang Yu 

Study leader:

Xiaowei Xu 

申请注册联系人电话:

Applicant telephone:

+86 13646876111 

研究负责人电话:

Study leader's telephone:

+86 13605708066 

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:

yu-liang@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

xxw69@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:

浙江省杭州市上城区庆春路79号浙医一院9号楼5楼 

研究负责人通讯地址:

浙江省杭州市上城区庆春路79号浙医一院6号楼A区10楼 

Applicant address:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China 

Study leader's address:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

310003 

研究负责人邮政编码:

Study leader's postcode:

310003 

申请人所在单位:

浙江大学医学院附属第一医院感染病科, 传染病诊治国家重点实验室, 国家感染性疾病临床医学研究中心 

Applicant's institution:

The First Affiliated Hospital of Zhejiang University, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Disease 

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-IIT-18 

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:

浙江大学医学院附属第一医院临床研究伦理委员会 

Name of the ethic committee:

Clinical Research Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-14 

伦理委员会联系人:

历有名 

Contact Name of the ethic committee:

Prof. Li Youming 

伦理委员会联系地址:

浙江省杭州市庆春路79号 

Contact Address of the ethic committee:

79 Qingchun Road, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Zhejiang University School of Medicine 

研究实施负责(组长)单位地址:

浙江省杭州上城区庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属第一医院

具体地址:

上城区庆春路79号

Institution
hospital:

The First Affiliated Hospital of Zhejiang University School of Medicine

Address:

79 Qingchun Road, Shangcheng District

经费或物资来源:

浙江省科技厅重点研发计划-2020C03123 

Source(s) of funding:

Key Research and Development Project of Zhejiang Province-2020C03123 

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:

探索性研究/预试验 

Study phase:

研究目的:

明确恢复期血清治疗重症新型冠状病毒肺炎患者的有效性及安全性。 

Objectives of Study:

Effecacy and safty of convalescent plasma treatment for severe patients with COVID19. 

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. 病毒核酸RT-PCR检测阳性的COVID19确诊患者; 2. 年龄>18岁; 3. 患者本人或家属签署书面知情同意书; 4. 尽管给与指南推荐的综合治疗仍病情进展需要重症监护。 

Inclusion criteria

1. Laboratory confirmed diagnosis of COVID19 infection by RT-PCR; 2. Aged > 18 years; 3. Written informed consent given by the patient or next-of-kin; 4. Clinical deterioration despite conventional treatment that required intensive care. 

排除标准:

1. 免疫球蛋白过敏; 2. 选择性IgA缺乏症。 

Exclusion criteria:

1. Hypersensitive to immunoglobulin; 2. Have immunoglobulin A deficiency. 

研究实施时间:

Study execute time:

From2020-02-15To 2022-02-15 

干预措施:

Interventions:

组别:

试验组

样本量:

10

Group:

experimental group

Sample size:

干预措施:

在标准化综合治疗基础上联合免疫血清治疗

干预措施代码:

Intervention:

standardized comprehensive treatment combined with convalescent plasma treatment

Intervention code:

组别:

对照组

样本量:

10

Group:

control group

Sample size:

干预措施:

标准化综合治疗

干预措施代码:

Intervention:

standardized comprehensive treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三级甲等医院 

Institution
hospital:

The First Affiliated Hospital of Zhejiang University School of Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

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:

重症监护时间

指标类型:

次要指标 

Outcome:

ICU 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:

呼吸道样本中病毒滴度

指标类型:

次要指标 

Outcome:

Viral titers in respiratory samples

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:

有创通气时间

指标类型:

次要指标 

Outcome:

incubation period

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

氧合指数

指标类型:

次要指标 

Outcome:

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:

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:

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:

痰液

组织:

Sample Name:

Sputum

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 16 years
最大 Max age 99 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

Non-randomized research

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

Non-randomized research

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:

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):

浙江省科技厅重点研发计划研究总结。网址:http://kjt.zj.gov.cn/

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

Research Summary of Key Research and Development Project of Zhejiang Province, url: http://kjt.zj.gov.cn/

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:

纸质版病例记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-15
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