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Analysis of Medical Characteristics of Covid-19 Patients in Xiamen Area
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注册号:

Registration number:

ChiCTR2100054156 

最近更新日期:

Date of Last Refreshed on:

2022-05-30 

注册时间:

Date of Registration:

2021-12-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

厦门地区Covid-19患者医学特征分析 

Public title:

Analysis of Medical Characteristics of Covid-19 Patients in Xiamen Area 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

厦门地区Covid-19患者医学特征分析 

Scientific title:

Analysis of Medical Characteristics of Covid-19 Patients in Xiamen Area 

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:

高占成 

研究负责人:

郑雅莉 

Applicant:

Gao Zhancheng 

Study leader:

Zheng Yali 

申请注册联系人电话:

Applicant telephone:

+86 13811957627 

研究负责人电话:

Study leader's telephone:

+86 18959200552 

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:

zcgao@xmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

yali_zheng@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:

福建省厦门市翔安区翔安东路2000号 

研究负责人通讯地址:

福建省厦门市翔安区翔安东路2000号 

Applicant address:

2000 Xiang'an Road East, Xiang'an District, Xiamen, Fujian 

Study leader's address:

2000 Xiang'an Road East, Xiang'an District, Xiamen, Fujian 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

厦门大学附属翔安医院 

Applicant's institution:

Xiang'an Hospital of Xiamen 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:

XAHLL2021025 

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:

厦门大学附属翔安医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Xiang'an Hospital of Xiamen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-10-30 

伦理委员会联系人:

邵晨 

Contact Name of the ethic committee:

Shao Chen 

伦理委员会联系地址:

福建省厦门市翔安区翔安东路2000号 

Contact Address of the ethic committee:

2000 Xiang'an Road East, Xiang'an District, Xiamen, Fujian 

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:

厦门大学附属翔安医院 

Primary sponsor:

Xiang'an Hospital of Xiamen University 

研究实施负责(组长)单位地址:

福建省厦门市翔安区翔安东路2000号 

Primary sponsor's address:

2000 Xiang'an Road East, Xiang'an District, Xiamen, Fujian 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

福建

市(区县):

厦门

Country:

China

Province:

Fujian

City:

Xiamen

单位(医院):

厦门大学附属翔安医院

具体地址:

翔安区翔安东路2000号

Institution
hospital:

Xiang'an Hospital of Xiamen University

Address:

2000 Xiang'an Road East, Xiang'an District

经费或物资来源:

厦门大学附属翔安医院中心实验室 

Source(s) of funding:

Central Laboratory of Xiang'an Hospital of Xiamen University 

研究疾病:

新型冠状病毒肺炎 

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:

其它 

Study phase:

N/A 

研究目的:

归纳、总结厦门市新型冠状病毒肺炎的症状、体征、实验室指标、肺功能、胸部CT等临床特征,比较出院后3、6、9、12个月时的临床指标的变化趋势。 

Objectives of Study:

To summarize the symptoms, signs, laboratory indicators, lung function, chest CT and other clinical features of the new type of coronavirus pneumonia in Xiamen, and compare the trends of clinical indicators at 3, 6, 9, and 12 months after discharge. 

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:

参考国家卫生健康委员会发布的《新型冠状病毒感染的肺炎诊疗方案(试行第八版)》的诊断标准,确诊病例需符合诊疗方案中的临床表现,且病原学检测阳性。 

Inclusion criteria

Meet the clinical manifestations in the Diagnosis and Treatment Plan for Pneumonia Infected by New Coronavirus (Trial Eighth Edition) issued by the National Health Commission, and have a positive pathogenic test. 

排除标准:

1. 入院48h死亡及相关实验室检查指标缺失者; 2. 无法进行随访的。 

Exclusion criteria:

1. Those who died within 48 hours of admission and the relevant laboratory test indicators were missing; 2. Unable to follow up. 

研究实施时间:

Study execute time:

From2021-11-11To 2023-12-30 

征募观察对象时间:

Recruiting time:

From2021-12-01To 2023-07-31 

干预措施:

Interventions:

组别:

新型冠状病毒肺炎组

样本量:

200

Group:

Covid-19 group

Sample size:

干预措施:

干预措施代码:

Intervention:

No

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

福建 

市(区县):

厦门 

Country:

China 

Province:

Fujian 

City:

Xiamen 

单位(医院):

厦门大学附属翔安医院 

单位级别:

三级甲等 

Institution
hospital:

Xiang'an Hospital of Xiamen University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

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:

指标中文名:

炎症指标

指标类型:

主要指标 

Outcome:

Inflammation indicators

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新冠特异性抗体

指标类型:

主要指标 

Outcome:

COVID-19 specific antibody

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:

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 years
最大 Max age 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):

Not applicable

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):

是否共享原始数据:

IPD sharing

No

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):

不适用

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

Not applicable

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:

不适用

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

Not applicable

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-12-10
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