ChiCTR2000031365 版本V1.1 版本创建时间2020/3/29 7:51:45 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR2000031365 

最近更新时间:

Date of Last Refreshed on:

2020/3/29 7:45:03 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

多中心多组学探索新型冠状病毒肺炎(COVID-19)重症患者发病机理和病程预测 

Public title:

To explore the pathogenesis and course prediction of novel coronavirus pneumonia (COVID-19) severe patients 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

新型冠状病毒肺炎(COVID-19)患者血清、尿液蛋白质和代谢组学标志物 

Scientific title:

Serum and urine proteins and metabolomic markers in patients with COVID-19 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

沈波 

研究负责人:

陈海啸 

Applicant:

Bo Shen 

Study leader:

Haixiao Chen 

申请注册联系人电话:

Applicant telephone:

+86 13586121278 

研究负责人电话:

Study leader's telephone:

+86 13706760666 

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:

shenb@enzemed.com 

研究负责人电子邮件:

Study leader's E-mail:

chenhx@enzemed.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:

浙江省临海市西门街150号 

研究负责人通讯地址:

浙江省临海市西门街150号 

Applicant address:

150 Ximen Street, Linhai, Zhejiang, China 

Study leader's address:

150 Ximen Street, Linhai, Zhejiang, 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:

浙江省台州医院 

Applicant's institution:

Taizhou Hospital of Zhejiang Province 

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:

K20200209 

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:

浙江省台州医院医学伦理委员会 

Name of the ethic committee:

Zhejiang Taizhou Hospital Medical Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-25 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

西湖大学 

Primary sponsor:

WESTLAKE UNIVERSITY 

研究实施负责(组长)单位地址:

浙江省杭州市西湖区石龙山街18号西湖大学 

Primary sponsor's address:

No,18,Shilongshan Road, Xihu District, Hangzhou,Zhejiang Province, China,Westlake University 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹 

Source(s) of funding:

self-collected 

研究疾病:

COVID-19 

Target disease:

COVID-19 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

诊断试验新技术临床试验 

Study phase:

Diagnostic New Technique Clincal Study 

研究目的:

本项目计划通浙江省的多家一线医疗机构合作、使用最新蛋白质谱技术联合迪安诊断-凯莱谱的HD4 Discovery 高质量精度、高灵敏度LC-MS代谢组学平台,对合作医院的灭毒处理后的COVID-19肺炎患者血液等生物样品的蛋白组和代谢小分子进行系统分析,探讨COVID-19重症患者的发病机理,以期在短时间内为下面三个迫切的临床问题提供新思路和诊断方法:1)部分肺炎患者为什么会进入重症?2)预测哪些肺炎患者有可能进入重症期? 2)重症患者应该如何选择用药? 最后,我们将联合多家医院进行多中心临床验证,并联合迪安诊断-凯莱谱开发可用于临床实践的诊疗方法。 

Objectives of Study:

We aim to perform Multi-Omics analysis (TMT-based quantitative proteomics combined LC-MS-based metabolomic analysis) from biological samples, such as blood and urine, reveal the pathogensis in COVID-19 patients in multicenter studies. In order to provide new ideas and diagnostic methods for the following three urgent clinical problems: 1) why some patients progressed into severe illness? 2) who could develop into severe illness? 3) what is the effective therapy for these severe patients? Finally, we will validate our study in multicenter studies and develop diagnosis and treatment of clinical practice with DiAn Diagnostics. 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

我们计划在2-4家医院(目前已有合作单位台州恩泽医疗中心浙江省台州医院和嘉兴市第一医院)搜集200例COVID-19肺炎患者的血清样品, 其中重症患者40名,轻症患者130名,普通流感患者30名。重症患者又分为转归良好的10名,经历细胞因子风暴后转归良好的10名,经历细胞因子风暴后转归差的10名,未经历细胞因子风暴后转归差的10名。我们将对这些患者病程中多个时间点的血清、尿液和粪便等样品进行搜集,经过灭活处理后进行多组学分析。 

Inclusion criteria

We anticipate collecting 200 COVID-19 serum samples (40 severe patients, 130 non-severe patients and 30 influza patients) in 2-4 hospitals. At present, there are two cooperate unit, Taizhou Hospital of Zhejiang Province and the First Hospital of Jiangxing. Severe patients include three categories: good prognosis, poor prognosis under cytokine storm and poor prognosis without cytokine storm. We will collect serum, urine and feces samples at multiple time points during the course of the disease to conduct multi-omics analysis. 

排除标准:

排除死亡,BMI指数不匹配病例 

Exclusion criteria:

Death was excluded. Cases with BMI mismatch were excluded 

研究实施时间:

Study execute time:

From2020-02-01To 2022-01-31 

干预措施:

Interventions:

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):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省台州医院 

单位级别:

三甲医院 

Institution
hospital:

Taizhou Hospital of Zhejiang Province  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

蛋白组学

指标类型:

主要指标 

Outcome:

proteomics

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

代谢组学

指标类型:

主要指标 

Outcome:

metabonomics

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SEN, SPE, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, AUC of ROC

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:

血清

组织:

Sample Name:

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:

尿液

组织:

Sample Name:

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:

粪便

组织:

Sample Name:

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 1 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):

不适用

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

NA

UTN(全球唯一识别码):

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

6M

Data collection Institution:

资料管理单位:

iprox.org

Data management Institution:

iprox.org

资料分析单位:

病例记录表、电子采集和管理系统

Data analysis Institution:

Case Record Form, CRF, Electronic Data Capture, EDC

注册人:

Name on Registration:

 2020-03-29