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Follow up study of convalescent patients of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000033105 

最近更新日期:

Date of Last Refreshed on:

2020-07-05 

注册时间:

Date of Registration:

2020-05-21 

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)患者康复期随访研究 

Public title:

Follow up study of convalescent patients of novel coronavirus pneumonia (COVID-19) 

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(COVID-19)患者康复期随访研究 

Scientific title:

Follow up study of convalescent patients of 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:

黄琪 

研究负责人:

金阳 

Applicant:

Huang Qi 

Study leader:

Jin Yang 

申请注册联系人电话:

Applicant telephone:

+86 15827329098 

研究负责人电话:

Study leader's telephone:

+86 13554361146 

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:

huangqi66@126.com 

研究负责人电子邮件:

Study leader's E-mail:

whuhjy@126.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:

湖北省武汉市江汉区解放大道1277号 

研究负责人通讯地址:

湖北省武汉市江汉区解放大道1277号 

Applicant address:

1277 Jiefang Avenue, Wuhan, Hubei, China  

Study leader's address:

1277 Jiefang Avenue, Wuhan, Hubei, China  

申请注册联系人邮政编码:

Applicant postcode:

430022 

研究负责人邮政编码:

Study leader's postcode:

430022 

申请人所在单位:

华中科技大学同济医学院附属协和医院 

Applicant's institution:

Union 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:

0271-01 

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:

华中科技大学同济医学院附属协和医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Union 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:

2020-02-20 

伦理委员会联系人:

梅恒 

Contact Name of the ethic committee:

Mei Heng 

伦理委员会联系地址:

武汉市解放大道1277号 

Contact Address of the ethic committee:

1277 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协和医院 

Primary sponsor:

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

研究实施负责(组长)单位地址:

湖北省武汉市江汉区解放大道1277号 

Primary sponsor's address:

1277 Jiefang Avenue, Jianghan District, 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

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

协和医院

具体地址:

解放大道1277号

Institution
hospital:

Union Hospital

Address:

1277 Jiefang Avenue

经费或物资来源:

国家自然科学基金专项项目 

Source(s) of funding:

Special Projects of the National Natural Science Foundation  

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:

COVID-19患者康复期随访研究 

Objectives of Study:

Follow up study of convalescent patients with covid-19 

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:

1. 距首发症状时间不少于3周(康复期) 2. 符合最新版新冠肺炎诊疗方案中解除隔离和出院标准 (连续两次核酸检测阴性+抗体IGG阳性+ct恢复期)康复期; 3. 年龄在18-70岁; 4. 复查新冠核酸抗体及ct者; 

Inclusion criteria

1. The time from the first symptom was no less than 3 weeks; 2. Corresponding to the release and discharge standard in latest "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection"; 3. Aged 18~70 years old; 4. Reexamination of nucleic acid, antibody and CT. 

排除标准:

1.代谢相关基础疾病(内科疾病,肿瘤,免疫抑制,内分泌代谢性疾病)和经血传播疾病史; 2.孕妇和哺乳期患者; 3.病史资料不齐者 

Exclusion criteria:

1. History of metabolic related basic diseases (tumor, immunosuppressive, endocrine and metabolic diseases) and blood borne diseases; 2. Pregnant and lactating patients; 3. Patients with incomplete medical history. 

研究实施时间:

Study execute time:

From2020-02-20To 2021-02-20 

征募观察对象时间:

Recruiting time:

From2020-02-20To 2021-02-20 

干预措施:

Interventions:

组别:

新冠状病毒肺炎康复期

样本量:

300

Group:

recovered COVID-19 group

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

组别:

健康人

样本量:

100

Group:

Healthy people

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

协和医院 

单位级别:

三甲医院 

Institution
hospital:

Union hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

患者一般信息:年龄,性别,住址,电话,既往史和BMI等流行病学指标

指标类型:

主要指标 

Outcome:

Patients' general information: epidemiological indicators such as age, gender, address, telephone, past medical history, and BMI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病情分度

指标类型:

主要指标 

Outcome:

Division of disease

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:

Metabolomics

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基因组学

指标类型:

主要指标 

Outcome:

Genomics

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

转录组学

指标类型:

主要指标 

Outcome:

Transcriptomics

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

蛋白质组学

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:

实验室检查

指标类型:

主要指标 

Outcome:

Laboratory inspection

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

影像学检查

指标类型:

主要指标 

Outcome:

Imaging examination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病原学检查

指标类型:

主要指标 

Outcome:

Etiological examination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

其余按照临床需要补充观察指标

指标类型:

主要指标 

Outcome:

The remaining observation indicators are supplemented according to clinical needs.

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

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

urine

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:

组织:

Sample Name:

sputum

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:

呼出气冷凝物

组织:

Sample Name:

exhaled breath condensate

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:

支气管肺泡灌洗液

组织:

Sample Name:

Bronchoalveolar lavage fluid

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 18 years
最大 Max age 70 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):

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 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):

以总结报告和论文形式公开

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

Be made public in the form of final reports and papers.

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:

数据使用CRF的方式收集,疫情期间,所有数据收集均采用电子化

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

The data was collected by CRF, and all data were collected electronically during the epidemic.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-05-21
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