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The efficacy and safety of convalescent plasma therapy in novel coronavirus pneumonia (COVID-19): A medical records based retrospective cohort study
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注册号:

Registration number:

ChiCTR2000033798 

最近更新日期:

Date of Last Refreshed on:

2020-06-12 

注册时间:

Date of Registration:

2020-06-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

康复期血浆治疗新型冠状病毒肺炎(COVID-19)的疗效及安全性:单中心回顾性队列研究 

Public title:

The efficacy and safety of convalescent plasma therapy in novel coronavirus pneumonia (COVID-19): A medical records based retrospective cohort study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

康复期血浆治疗新型冠状病毒肺炎(COVID-19)的疗效及安全性:单中心回顾性队列研究 

Scientific title:

The efficacy and safety of convalescent plasma therapy in novel coronavirus pneumonia (COVID-19): A medical records based retrospective 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:

卞毅 

研究负责人:

房明浩 

Applicant:

Yi Bian 

Study leader:

Minghao Fang 

申请注册联系人电话:

Applicant telephone:

+86 15102710366 

研究负责人电话:

Study leader's telephone:

+86 15071157405 

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:

bianyi2526@163.com 

研究负责人电子邮件:

Study leader's E-mail:

fangmhtj@163.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:

中国湖北省武汉市解放大道1095号同济医院急诊/重症医学科 

研究负责人通讯地址:

中国湖北省武汉市解放大道1095号 

Applicant address:

1095 Jiefang Avenue, Tongji Hospital, Wuhan, Hubei, China 

Study leader's address:

1095 Jiefang Avenue, Tongji Hospital, Wuhan, Hubei, China 

申请注册联系人邮政编码:

Applicant postcode:

430030 

研究负责人邮政编码:

Study leader's postcode:

430030 

申请人所在单位:

华中科技大学同济医学院附属同济医院急诊/重症医学科 

Applicant's institution:

Eergency / Intensive Care Department of Tongji Hospital, 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:

TJ-IRB20200508 

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:

华中科技大学同济医学院附属同济医院医学伦理委员会 

Name of the ethic committee:

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

伦理委员会批准日期:

Date of approved by ethic committee:

2020-05-29 

伦理委员会联系人:

杜艾桦 

Contact Name of the ethic committee:

Aihua Du 

伦理委员会联系地址:

湖北省武汉市解放大道1095号同济医院7号楼1003室 

Contact Address of the ethic committee:

Room 1003, Building 7, Tongji Hospital, 1095 Jiefang Avenue, Wuhan, 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同济医院 

Primary sponsor:

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

研究实施负责(组长)单位地址:

湖北省武汉市硚口区解放大道1095号 

Primary sponsor's address:

1095 Jie Fang Avenue, 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同济医院

具体地址:

中国湖北省武汉市解放大道1095号

Institution
hospital:

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

Address:

1095 Jiefang Avenue

经费或物资来源:

自筹经费 

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:

观察性研究 

Study type:

Observational study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

到目前为止,尚无证实的对COVID-19有效的抗病毒特效治疗手段。康复期血浆(convalescent plasma, CP)治疗是一种可以追溯到19世纪早期的古老免疫治疗手段。近二十年来,CP治疗已被成功且安全的用于SARS、MERS和2009 H1N1等大流行病毒感染性疾病的治疗。本研究拟以华中科技大学同济医学院附属同济医院的两个院区共收治的约2800例COVID-19患者为研究对象,通过比较使用和未使用CP治疗患者的死亡率、并发症发生率、病毒载量变化、新型冠状病毒抗体IgG、IgM及其他临床指标的差异,探寻CP治疗的安全性及有效性。 

Objectives of Study:

To date, there is no proven specific antiviral treatment for COVID-19. Convalescent plasma (CP) therapy is an ancient immunotherapy technique that dates back to the early 19th century. Over the past two decades, CP has been successfully and safely used to treat pandemics such as SARS, MERS and 2009 H1N1. This study intends to include 2800 COVID-19 patients admitted to Tongji hospital of Tongji medical college of Huazhong University of Science and technology. By comparing mortality, incidence of complications of CP therapy, serum SARS-CoV-2 RNA load, serum antibody titers of IgG and IgM, as well as other clinical characters of patients with and without CP therapy, we are trying to explore the efficacy and safety of CP treatment. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

符合WHO新型冠状病毒肺炎确诊标准 

Inclusion criteria

Meets COVID-19 diagnosis criteria of WHO 

排除标准:

1)年龄<18周岁; 2)孕妇; 3)住院时间<24小时; 4)必要的临床资料信息不完整; 5)与新型冠状病毒肺炎无直接关系的严重并发症(包括但不限于外科急症、颅内出血、多发伤等); 6)入院24小时内死亡。 

Exclusion criteria:

1. age <18 years; 2. pregnant; 3. length of hospital <24 hours; 4. insufficient clinical information; 5. serious complications not directly related to the COVID0-19 (including but not limited to surgical emergencies, intracranial hemorrhage, multiple injuries, etc.); 6. dead within 24 hours from admission. 

研究实施时间:

Study execute time:

From2020-06-12To 2021-06-11 

征募观察对象时间:

Recruiting time:

From2020-06-12To 2020-07-31 

干预措施:

Interventions:

组别:

康复期血浆治疗组

样本量:

50

Group:

convalescent plasma therapy group

Sample size:

干预措施:

干预措施代码:

Intervention:

no

Intervention code:

组别:

非康复期血浆治疗组

样本量:

100

Group:

non-convalescent plasma therapy group

Sample size:

干预措施:

干预措施代码:

Intervention:

no

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

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同济医院 

单位级别:

三甲医院 

Institution
hospital:

Tongji Hospital, 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:

在院全因死亡率

指标类型:

主要指标 

Outcome:

all cause in-hospital mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血浆SARS-CoV-2病毒RNA载量

指标类型:

次要指标 

Outcome:

serum SARS-CoV-2 RNA load

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血浆IgG、IgM抗体滴度

指标类型:

次要指标 

Outcome:

serum antibody titers of IgG and IgM

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:

no

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 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):

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

no

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):

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):

网络 公开时间:2020.10.1 网址:http://www.chictr.org.cn/

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

Web-based Date: 2020.10.1 URL: http://www.chictr.org.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:

数据采集使用人工填写病历记录表。数据录入使用Microsoft Office Excel 2016、SPSS19.0和中国临床试验注册中心提供的在线ResMan系统进行录入和数据管理。

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

Case record form(CRF) will be recorded manually for the data collection. Microsoft Office Excel 2016, SPSS19.0 and Resman system would be used for the data input and management.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-06-12
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