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Outcomes of and Prognosis Factors for COVID-19 Patients: An Observational Study
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注册号:

Registration number:

ChiCTR2000038943 

最近更新日期:

Date of Last Refreshed on:

2020-10-16 

注册时间:

Date of Registration:

2020-10-10 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

新型冠状病毒肺炎患者预后及影响因素研究——观察性研究 

Public title:

Outcomes of and Prognosis Factors for COVID-19 Patients: An Observational Study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型冠状病毒肺炎患者预后及影响因素研究——观察性研究 

Scientific title:

Outcomes of and Prognosis Factors for COVID-19 Patients: An Observational 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:

顿耀山 

研究负责人:

刘遂心 

Applicant:

Yaoshan Dun 

Study leader:

Suixin Liu 

申请注册联系人电话:

Applicant telephone:

+86 15073163301 

研究负责人电话:

Study leader's telephone:

+86 13618476706 

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:

dunyaoshan@csu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

liusuixin@csu.edu.cn 

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:

中国湖南长沙市湘雅路87号 

研究负责人通讯地址:

中国湖南长沙市湘雅路87号 

Applicant address:

87 Xiangya Road, Changsha, Hu'nan, China  

Study leader's address:

87 Xiangya Road, Changsha, Hu'nan, China 

申请注册联系人邮政编码:

Applicant postcode:

410008 

研究负责人邮政编码:

Study leader's postcode:

410008 

申请人所在单位:

中南大学湘雅医院康复医学科 

Applicant's institution:

Department of Physical Medicine and Rehabilitation, Xiangya Hospital, Central South 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:

KX-2020047 

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:

长沙市第一医院伦理委员会 

Name of the ethic committee:

Medical ethics committee of First Hospital of Changsha 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-05-18 

伦理委员会联系人:

李波 

Contact Name of the ethic committee:

Bo Li 

伦理委员会联系地址:

中国湖南长沙开福区营盘路311号 

Contact Address of the ethic committee:

311 Yingpan Road, Kaifu District, Changsha, Hu'nan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 731 84626790 

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:

中南大学湘雅医院 

Primary sponsor:

Xiangya Hospital, Central South University 

研究实施负责(组长)单位地址:

湖南长沙湘雅路87号 

Primary sponsor's address:

87 Xiangya Road, Changsha, Hu'nan, 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):

湖南

市(区县):

长沙

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

中南大学湘雅医院

具体地址:

中国湖南长沙湘雅路87号

Institution
hospital:

Xiangya Hospital, Central South University

Address:

87 Xiangya Road, Changsha, Hu'nan

经费或物资来源:

研究者发起 

Source(s) of funding:

Investigator Initalated Study 

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:

其它 

Study phase:

N/A 

研究目的:

1.探究COVID-19患者中长期预后的情况; 2.探究影响COVID-19患者预后的相关因素,包括住院期和恢复期相关因素。 

Objectives of Study:

1. To explore the medium- and long-term outcomes of patients with COVID-19; 2. To investigate the prognosis factors of COVID-19 patients. 

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:

长沙市第一人医院确诊的所有233名COVID-19患者。 

Inclusion criteria

A total of 233 consecutive COVID-19 patients who were admitted to the First Hospital of Changsha, China from January 17th to February 29th, 2020. 

排除标准:

1.住院期死亡患者; 2.出院后未定期到医院复诊和随访。 

Exclusion criteria:

1. Patients who died during hospitalization; 2. Patients who have not completed scheduled follow-up after discharge. 

研究实施时间:

Study execute time:

From2020-01-17To 2021-02-28 

征募观察对象时间:

Recruiting time:

From2020-01-17To 2020-02-29 

干预措施:

Interventions:

组别:

Case series

样本量:

233

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hu'nan 

City:

Changsha 

单位(医院):

长沙市第一医院 

单位级别:

三甲医院 

Institution
hospital:

First Hospital of Changsha  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

患者新型冠状病毒特异性抗体

指标类型:

主要指标 

Outcome:

IgG and IgM against SARS-CoV-2

Type:

Primary indicator 

测量时间点:

出院后2周、3个月、6个月、12个月

测量方法:

试剂盒

Measure time point of outcome:

2 weeks, 3 months, 6 months, 12 months after discharge

Measure method:

IgG and IgM against SARS-CoV-2 were detected in serum samples using 2019-nCoV Ab test kits (Innovita, China), according to the manufacturer’s instructions

指标中文名:

T细胞

指标类型:

主要指标 

Outcome:

T cells

Type:

Primary indicator 

测量时间点:

出院后2周、3个月、6个月、12个月

测量方法:

荧光标记法和多参数流式细胞术

Measure time point of outcome:

2 weeks, 3 months, 6 months, 12 months after discharge

Measure method:

BD FACSCalibur Cell Sorting System (Biosciences, US), with BD Tirtest CD4/CD8/CD3 reagent according to the manufacturer’s instructions.

指标中文名:

血液学检查

指标类型:

主要指标 

Outcome:

Routine blood tests

Type:

Primary indicator 

测量时间点:

出院后2周、3个月、6个月、12个月

测量方法:

参照说明书

Measure time point of outcome:

2 weeks, 3 months, 6 months, 12 months after discharge

Measure method:

Refer to the manufacturer’s instructions.

指标中文名:

胸部CT

指标类型:

主要指标 

Outcome:

Chest CT

Type:

Primary indicator 

测量时间点:

出院后2周、3个月、6个月、12个月

测量方法:

CT扫描仪

Measure time point of outcome:

2 weeks, 3 months, 6 months, 12 months after discharge

Measure method:

Computed Tomography Scanners

指标中文名:

运动能力

指标类型:

主要指标 

Outcome:

Athletic ability

Type:

Primary indicator 

测量时间点:

出院后3个月、6个月、12个月

测量方法:

医学量表

Measure time point of outcome:

2 weeks, 3 months, 6 months, 12 months after discharge

Measure method:

Questionnaire

指标中文名:

生活质量

指标类型:

主要指标 

Outcome:

Quality of life

Type:

Primary indicator 

测量时间点:

出院后3个月、6个月、12个月

测量方法:

医学量表

Measure time point of outcome:

2 weeks, 3 months, 6 months, 12 months after discharge

Measure method:

Questionnaire

指标中文名:

心理状态

指标类型:

主要指标 

Outcome:

Psychology

Type:

Primary indicator 

测量时间点:

出院后3个月、6个月、12个月

测量方法:

医学量表

Measure time point of outcome:

2 weeks, 3 months, 6 months, 12 months after discharge

Measure method:

Questionnaire

指标中文名:

六分钟步行实验

指标类型:

主要指标 

Outcome:

Six minutes walk test

Type:

Primary indicator 

测量时间点:

出院后3个月、6个月、12个月

测量方法:

Measure time point of outcome:

2 weeks, 3 months, 6 months, 12 months after discharge

Measure method:

指标中文名:

康复次数

指标类型:

主要指标 

Outcome:

Rehabilitation sessions

Type:

Primary indicator 

测量时间点:

出院后2周、3个月、6个月、12个月

测量方法:

Measure time point of outcome:

2 weeks, 3 months, 6 months, 12 months after discharge

Measure method:

指标中文名:

体力活动量

指标类型:

主要指标 

Outcome:

Volume of physical activity

Type:

Primary indicator 

测量时间点:

出院后3个月、6个月、12个月

测量方法:

医学量表

Measure time point of outcome:

2 weeks, 3 months, 6 months, 12 months after discharge

Measure method:

Questionnaire

指标中文名:

体重

指标类型:

主要指标 

Outcome:

Body weight

Type:

Primary indicator 

测量时间点:

出院后2周、3个月、6个月、12个月

测量方法:

Measure time point of outcome:

2 weeks, 3 months, 6 months, 12 months 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 12 years
最大 Max age 84 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):

N/A

盲法:

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:

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):

临床数据公共管理平台, http://www.medresman.org.cn

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

Research Manager, http://www.medresman.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:

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, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-10-10
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