今天是:2022-08-12 星期五

一项新型冠状病毒肺炎复阳患者的临床特点分析的单中心、观察性研究
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注册号:

Registration number:

ChiCTR2200061874 

最近更新日期:

Date of Last Refreshed on:

2022-07-05 

注册时间:

Date of Registration:

2022-07-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项新型冠状病毒肺炎复阳患者的临床特点分析的单中心、观察性研究 

Public title:

A single-center, observational study of clinical characteristics of patients with novel coronavirus pneumonia re-positive 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一项新型冠状病毒肺炎复阳患者的临床特点分析的单中心、观察性研究 

Scientific title:

A single-center, observational study of clinical characteristics of patients with novel coronavirus pneumonia re-positive 

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:

翟炜 

研究负责人:

郑军华 

Applicant:

Wei Zhai 

Study leader:

Junhua Zheng 

申请注册联系人电话:

Applicant telephone:

18701771959 

研究负责人电话:

Study leader's telephone:

13901722408 

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:

jackyzw2007@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhengjh0471@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:

上海市浦东新区浦建路160号上海交通大学医学院附属仁济医院 

研究负责人通讯地址:

上海市浦东新区浦建路160号上海交通大学医学院附属仁济医院  

Applicant address:

Renji Hospital, Shanghai Jiao Tong University School of Medicine, 160 Pujian Rd, Shanghai 200127, China 

Study leader's address:

Renji Hospital, Shanghai Jiao Tong University School of Medicine, 160 Pujian Rd, Shanghai 200127, China  

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:

上海交通大学医学院附属仁济医院 

Applicant's institution:

Renji Hospital, 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:

KY2022-114-B 

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仁济医院伦理委员会 

Name of the ethic committee:

Ethics Committee,Renji Hospital, Shanghai Jiao Tong University School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2022-06-14 

伦理委员会联系人:

上海交通大学医学院附属仁济医院伦理委员会 

Contact Name of the ethic committee:

Ethics Committee,Renji Hospital, Shanghai Jiao Tong University School of Medicine 

伦理委员会联系地址:

上海市浦东新区浦建路160号上海交通大学医学院附属仁济医院 

Contact Address of the ethic committee:

Renji Hospital, Shanghai Jiao Tong University School of Medicine, 160 Pujian Rd, Shanghai 200127, 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:

上海交通大学附属仁济医院 

Primary sponsor:

Renji Hospital, School of Medicine, Shanghai Jiao Tong University 

研究实施负责(组长)单位地址:

Haining Road No.100, Hongkou District, Shanghai  

Primary sponsor's address:

Renji Hospital, Shanghai Jiao Tong University School of Medicine, 160 Pujian Rd, Shanghai 200127, 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

市(区县):

浦东新区

Country:

China

Province:

Shanghai

City:

Pudong District

单位(医院):

上海交通大学医学院附属仁济医院

具体地址:

上海市浦东新区浦建路160号上海交通大学附属仁济医院

Institution
hospital:

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Address:

Renji Hospital, Shanghai Jiao Tong University School of Medicine, 160 Pujian Rd, Shanghai 200127, China

经费或物资来源:

无 

Source(s) of funding:

研究疾病:

COVID-19 

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:

分析新型冠状病毒肺炎复阳患者的临床特点及危险因素。 

Objectives of Study:

To analyze the clinical characteristics and risk factors of patients with 2019-nCoV pneumonia. 

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:

1) 参与前书面签署知情同意书,年龄18-80岁,性别不限; 2) 之前曾经感染过新型冠状病毒且康复(转阴) 3) 检测新冠病毒核酸CT值再次低于35(核酸阳性) 4) ECOG活动状态评分为0-2分。 5) 必须同意且能遵守研究计划。 

Inclusion criteria

1) Sign the informed consent in writing before participating, aged 18-80 years old, regardless of gender; 2) Previously infected with the new coronavirus and recovered (turned negative) 3) The CT value of the new coronavirus nucleic acid is lower than 35 again (nucleic acid positive) 4) ECOG activity status score is 0-2 points. 5) Must agree and be able to comply with the research plan. 

排除标准:

1) 年龄超过80岁,或ECOG评分大于等于3级者; 2) 存在未经治疗的肿瘤伴全身多发转移者; 3) 参加研究前28天内接受过重大外科手术者; 4) 具有不受控的活动性出血或出血性倾向; 5) 妊娠或哺乳期妇女; 6) 纽约心脏协会III级或IV级充血性心力衰竭; 7) 存在不受控的并发疾病,且这些因素将影响受试者对本研究相关要求的依从性。 

Exclusion criteria:

1) Those who are over 80 years old, or whose ECOG score is greater than or equal to 3; 2) There are untreated tumors with multiple systemic metastases; 3) Those who have undergone major surgical operations within 28 days before participating in the study; 4) Uncontrolled active bleeding or bleeding tendency; 5) Pregnant or lactating women; 6) New York Heart Association class III or IV congestive heart failure; 7) There are uncontrolled concurrent diseases, and these factors will affect the subject's compliance with the relevant requirements of this study. 

研究实施时间:

Study execute time:

From2022-05-01To 2022-08-31 

征募观察对象时间:

Recruiting time:

From2022-07-05To 2022-08-31 

干预措施:

Interventions:

组别:

/

样本量:

381

Group:

/

Sample size:

干预措施:

/

干预措施代码:

Intervention:

/

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 

市(区县):

浦东新区 

Country:

China 

Province:

Shanghai 

City:

Pudong District 

单位(医院):

上海交通大学医学院附属仁济医院 

单位级别:

三级 

Institution
hospital:

Renji Hospital, School of Medicine, Shanghai Jiao Tong University  

Level of the institution:

tertiary hospital 

测量指标:

Outcomes:

指标中文名:

新冠复阳患者的流行病学和临床特征

指标类型:

主要指标 

Outcome:

Epidemiological and clinical characteristics of patients with new crown re-positive

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:

尚未开始

Not yet 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):

/

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

/

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否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):

/

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

/

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:

见研究方案附件

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

See research protocol annex

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-07-05
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