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重症/危重症新型冠状病毒肺炎(COVID-19)患者预警预测体系构建
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注册号:

Registration number:

ChiCTR2000029625 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

重症/危重症新型冠状病毒肺炎(COVID-19)患者预警预测体系构建 

Public title:

Construction of Early Warning and Prediction System for Patients with Severe / Critical Novel Coronavirus Pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

重症/危重症新型冠状病毒肺炎(COVID-19)患者预警预测体系构建 

Scientific title:

Construction of Early Warning and Prediction System for Patients with Severe / Critical Novel 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:

黄灵童 

研究负责人:

蔡洪流 

Applicant:

Huang Lingtong 

Study leader:

Cai Hongliu 

申请注册联系人电话:

Applicant telephone:

+86 18767721955 

研究负责人电话:

Study leader's telephone:

+86 13505811696 

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:

hltzju@163.com 

研究负责人电子邮件:

Study leader's E-mail:

caiicu@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:

浙江省杭州市庆春路79号 

研究负责人通讯地址:

浙江省杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang, China 

Study leader's address:

79 Qingchun Road, 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 

Applicant's institution:

The First Affiliated Hospital of Zhejiang University School of Medicine  

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同意函第(34)号 

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:

The Clinical Research Ethic Committee of the First Affiliated Hospital of Zhejiang University School of Medicine  

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:

蒋怡雅 

Contact Name of the ethic committee:

Jiang Yiya 

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:

浙江省杭州市庆春路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:

庆春路79号

Institution
hospital:

The First Affiliated Hospital, Zhejiang University School of Medicine

Address:

79 Qingchun Road

经费或物资来源:

自筹 

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:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

根据患者临床资料、免疫特征构建危重症新型冠状病毒感染患者的预警预测体系 

Objectives of Study:

Construction of an early warning and prediction system for patients with severe 2019-nCoV Pneumonia based on clinical data and immune characteristics 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1. 新型冠状病毒核酸检查(RT-PCR)检查阳性,并伴有临床表现的确诊新型冠状病毒感染的肺炎患者。诊断标准参考《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》。 2. 已住院的新诊断的呼吸系统不适的患者(呼吸系统不适确诊时间不超过10天)。 3. 自愿签署知情同意书的患者。  

Inclusion criteria

1. Patients with novel coronavirus infection pneumonia were confirmed by RT-PCR and clinical symptoms. The diagnosic criteria refer to "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5)"; 2. Patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 10 days); 3. Patients who voluntarily signed informed consent.  

排除标准:

研究者判断不适合参加本次临床试验者(如研究期间可能转院治疗患者;合并多种基础疾病患者等)。  

Exclusion criteria:

Physician judged the patient was not suitable for this clinical trial (for example, patient may be transferred to another hospital during the study period; patient with immune system diseases or cancers etc.) 

研究实施时间:

Study execute time:

From2020-02-17To 2020-08-01 

征募观察对象时间:

Recruiting time:

From2020-02-17To 2020-07-01 

诊断试验:

Diagnostic Tests:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

临床结局

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Clinical outcome

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

预警预测体系

Index test:

early warning and prediction system

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

确诊新型冠状病毒感染的肺炎患者

例数:

Sample size:

80

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Confirmed 2019-nCoV pneumonia patients

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

住院的新诊断的呼吸系统不适的患者(呼吸系统不适确诊时间不超过10天)

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

Patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 10 days)

研究实施地点:

Countries of recruitment and research settings:

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 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital, Zhejiang University School of Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

淋巴细胞亚群分析

指标类型:

主要指标 

Outcome:

Lymphocyte subpopulation analysis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

细胞因子检测

指标类型:

主要指标 

Outcome:

Cytokine detection

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

支气管灌洗细胞单细胞测序

指标类型:

主要指标 

Outcome:

Single cell sequencing of bronchial lavage fluid cells

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:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

支气管肺泡灌洗液

组织:

Sample Name:

bronchial lavage fluid

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 90 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):

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

No

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

待完善

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

To be perfected

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. 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:

 2020-02-07
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