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Clinical study for the potential impact of novel coronavirus pneumonia (COVID-19) on endocrine system
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注册号:

Registration number:

ChiCTR2000032233 

最近更新日期:

Date of Last Refreshed on:

2020-04-23 

注册时间:

Date of Registration:

2020-04-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型冠状病毒肺炎(COVID-19)对内分泌系统潜在影响的临床研究 

Public title:

Clinical study for the potential impact of novel coronavirus pneumonia (COVID-19) on endocrine system 

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)对内分泌系统潜在影响的临床研究 

Scientific title:

Clinical study for the potential impact of novel coronavirus pneumonia (COVID-19) on endocrine system 

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:

毛燕飞 

研究负责人:

江来 

Applicant:

Mao Yanfei 

Study leader:

Jiang Lai 

申请注册联系人电话:

Applicant telephone:

+86 13918402532 

研究负责人电话:

Study leader's telephone:

+86 13651695976 

申请注册联系人传真 :

Applicant Fax:

+86 021-25078999 

研究负责人传真:

Study leader's fax:

+86 021-25078999 

申请注册联系人电子邮件:

Applicant E-mail:

maoyanfei1979@163.com 

研究负责人电子邮件:

Study leader's E-mail:

jianglaimz@sina.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:

上海市控江路1665号 

研究负责人通讯地址:

上海市控江路1665号 

Applicant address:

1665 Kongjiang Road, Yangpu District, Shanghai, China 

Study leader's address:

1665 Kongjiang Road, Yangpu District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200092 

研究负责人邮政编码:

Study leader's postcode:

200092 

申请人所在单位:

上海交通大学医学院附属新华医院 

Applicant's institution:

Xinhua Hospital Affiliated to Shanghai Jiao Tong 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:

XHEC-D-2020-073 

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:

上海交通大学医学院附属新华医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-23 

伦理委员会联系人:

施敏 

Contact Name of the ethic committee:

Shi Min 

伦理委员会联系地址:

上海市杨浦区控江路 1665 号 

Contact Address of the ethic committee:

1665 Kongjiang Road, Yangpu District, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021-25076143 

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:

上海交通大学医学院附属新华医院 

Primary sponsor:

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine  

研究实施负责(组长)单位地址:

上海市杨浦区控江路 1665 号 

Primary sponsor's address:

1665 Kongjiang Road, Yangpu District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属新华医院

具体地址:

上海市杨浦区控江路 1665 号

Institution
hospital:

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Address:

1665 Kongjiang Road, Yangpu District

经费或物资来源:

自筹 

Source(s) of funding:

self-raised funds 

研究疾病:

SARS-CoV-2 

Target disease:

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

观察COVID-19是否对内分泌系统具有潜在影响。 

Objectives of Study:

The purpose of the project is to observe whether COVID-19 has a potential impact on the endocrine system. 

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)年龄大于18岁; (2)COVID-19重型/危重型患者; (3)非COVID-19重型/危重型患者.  

Inclusion criteria

(1) The age is greater than 18 years old; (2) COVID-19 severe / critically ill patients; (3) Non-COVID-19 severe / critically ill patients. 

排除标准:

(1)年龄小于18岁; (2)严重精神疾病; (3)存在内分泌系统疾病; (4)孕产妇。 

Exclusion criteria:

(1) The age is less than 18 years old; (2) Severe mental illness; (3) The existence of endocrine system diseases; (4) Maternity. 

研究实施时间:

Study execute time:

From2020-04-23To 2020-05-06 

征募观察对象时间:

Recruiting time:

From2020-04-23To 2020-05-06 

干预措施:

Interventions:

组别:

COVID-19危重型患者

样本量:

8

Group:

COVID-19 critically ill patients;

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

组别:

非COVID-19危重型患者

样本量:

8

Group:

Non-COVID-19 critically ill patients.

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

组别:

正常对照组织

样本量:

12

Group:

Normal tissue

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):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属新华医院 

单位级别:

三甲医院 

Institution
hospital:

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海公共卫生中心 

单位级别:

三甲医院 

Institution
hospital:

Shanghai municipal public health center  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

血清甲状腺水平

指标类型:

主要指标 

Outcome:

serum thyroid levels

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

皮质醇水平

指标类型:

主要指标 

Outcome:

cortisol levels

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血管紧张素转化酶II

指标类型:

主要指标 

Outcome:

ACE2

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:

肾上腺

组织:

Sample Name:

adrenal gland

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:

甲状腺

组织:

Sample Name:

thyroid

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:

肺组织

组织:

Sample Name:

lung tissue

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:

小肠组织

组织:

Sample Name:

small intestine tissue

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:

血清

组织:

Sample Name:

serum

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:

结束

Completed

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):

No

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

No

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:

Real time access

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):

发表研究成果即刻共享

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

Share research results in the form of an article

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:

数据采集采用Case Record Form

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

Data collection adopts Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-04-23
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