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新型冠状病毒肺炎(COVID-19)康复期的随访研究
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注册号:

Registration number:

ChiCTR2000034563 

最近更新日期:

Date of Last Refreshed on:

2020-07-10 

注册时间:

Date of Registration:

2020-07-10 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

新型冠状病毒肺炎(COVID-19)康复期的随访研究 

Public title:

Follow-up study on the recovery period of novel coronavirus pneumonia (COVID-19) patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型冠状病毒肺炎康复期的随访研究 

Scientific title:

Prospective follow-up cohort study of novel coronavirus pneumonia (COVID-19) patients during recovery period 

研究课题代号(代码):

Study subject ID:

K-2020-02 

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:

刘大凤 

研究负责人:

兰丽娟 

Applicant:

Dafeng Liu 

Study leader:

Lijuan Lan 

申请注册联系人电话:

Applicant telephone:

+86 028 84541837 

研究负责人电话:

Study leader's telephone:

+86 13982109183 

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:

993896436@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

yuerlan2006@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:

成都市锦江区静居寺路18号 

研究负责人通讯地址:

成都市锦江区静居寺路18号 

Applicant address:

18 Jingjusi Road, Jinjiang District, Chengdu, Sichuan, China 

Study leader's address:

18 Jingjusi Road, Jinjiang District, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

610061 

研究负责人邮政编码:

Study leader's postcode:

610061 

申请人所在单位:

成都市公共卫生临床医疗中心 

Applicant's institution:

the Public and Health Clinic Centre of Chengdu 

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:

PJ-K2020-06-01 

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:

成都市公共卫生临床医疗中心医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Chengdu Public and Health Clinic Centre of Chengdu 

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:

范颖 

Contact Name of the ethic committee:

Ying Fan 

伦理委员会联系地址:

成都市锦江区静明路377号 

Contact Address of the ethic committee:

377 Jingming Road, Jinjiang District, Chengdu, Sichuan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 028 64369118 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

553566446@qq.com 

研究实施负责(组长)单位:

成都市公共卫生临床医疗中心 

Primary sponsor:

the Public and Health Clinic Centre of Chengdu 

研究实施负责(组长)单位地址:

成都市锦江区静明路377号 

Primary sponsor's address:

377 Jingming Road, Jinjiang District, Chengdu, Sichuan, 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):

四川省

市(区县):

成都市

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都市公共卫生临床医疗中心

具体地址:

成都市锦江区静明路377号

Institution
hospital:

the Public and Health Clinic Centre of Chengdu

Address:

377 Jingming Road, Jinjiang District, Chengdu

经费或物资来源:

四川省科技厅项目 

Source(s) of funding:

Sichuan Science and Technology Department Project 

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:

通过该研究获得新型冠状病毒肺炎病人长期心、肺功能的动态变化情况、影像学特点、免疫学指标及生化情况等,指导患者康复训练,并获得此类患者的心肺功能等康复期相关数据,为以后开展新型冠状病毒肺炎患者心肺功能康复治疗提供依据和经验借鉴。 

Objectives of Study:

Through this study, we can obtain the long-term dynamic changes of heart and lung function parameters, imaging characteristics, immunological indicators and biochemical indicators of patients with coronavirus disease 2019, guide the rehabilitation training of patients, and obtain relevant data of such patients in cardiopulmonary and lung function during rehabilitation period,provide a reference for the future development of cardiopulmonary function rehabilitation treatment of patients with coronavirus disease 2019. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

新型冠状病毒感染住院治愈出院患者;年龄18~80岁。 

Inclusion criteria

New coronavirus infection hospitalized and cured patients discharged; aged 18 to 80 years. 

排除标准:

非新型冠状病毒感染者;妊娠患者;哺乳患者;年龄<18岁或>80岁。 

Exclusion criteria:

Non-new coronavirus infections; pregnant patients; lactating patients. 

研究实施时间:

Study execute time:

From2020-02-16To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2020-02-16To 2020-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

50

Group:

Case series

Sample size:

干预措施:

肺康复训练

干预措施代码:

Intervention:

Pulmonary rehabilitation training

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

成都市 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

成都市公共卫生临床医疗中心 

单位级别:

三级甲等 

Institution
hospital:

the Public and Health Clinic Centre of Chengdu  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

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:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

淋巴细胞亚群

指标类型:

主要指标 

Outcome:

Lymphocyte and subsets

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新冠病毒核酸

指标类型:

主要指标 

Outcome:

New coronavirus nucleic acid

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新冠病毒特异性抗体

指标类型:

主要指标 

Outcome:

New coronavirus specific antibody

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心脏彩超

指标类型:

主要指标 

Outcome:

Echocardiography

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

主要指标 

Outcome:

Electrocardiogram

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺功能

指标类型:

主要指标 

Outcome:

Lung function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

6分钟步行距离

指标类型:

主要指标 

Outcome:

6 minutes walking distance

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血生化指标

指标类型:

主要指标 

Outcome:

Blood chemistry

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

主要指标 

Outcome:

Blood routine

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:

静脉血

Sample Name:

blood

Tissue:

Venous blood

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:

鼻咽拭子

组织:

鼻咽部分泌物

Sample Name:

Nasopharyngeal swab

Tissue:

Nasopharyngeal discharge

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 18 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):

队列研究,不用随机

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

N/A

盲法:

N/A

Blinding:

N/A

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):

通过研究负责人的邮箱获得

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

Obtained through the email of the person in charge of research

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:

经过培训的专人进行数据采集,数据采集和管理由两部分组成,数据采集为病例记录表(Case Record Form, CRF);数据管理亦由专人管理,双录入,课题负责人抽查,保证数据全面、真实、准确、完整。

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

Data collection and management consists of two parts. The data collection and management are composed of two parts. The data collection is a case record form (CRF); data management is also managed by a special person, double entry, and the subject person conducts random checks to ensure that the data is comprehensive, True, accurate and complete.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-07-10
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