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Development and clinical application of novel coronavirus pneumonia (COVID-19) antigen reagent
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注册号:

Registration number:

ChiCTR2000031700 

最近更新日期:

Date of Last Refreshed on:

2020-04-07 

注册时间:

Date of Registration:

2020-04-07 

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)抗原试剂的研发和临床应用 

Public title:

Development and clinical application of novel coronavirus pneumonia (COVID-19) antigen reagent 

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)抗原试剂的研发和临床应用 

Scientific title:

Development and clinical application of novel coronavirus pneumonia (COVID-19) antigen reagent 

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:

张春燕 

研究负责人:

张春燕 

Applicant:

Zhang Chunyan 

Study leader:

Zhang Chunyan 

申请注册联系人电话:

Applicant telephone:

+86 18810882866 

研究负责人电话:

Study leader's telephone:

+86 18810882866 

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:

rebrcca@126.com 

研究负责人电子邮件:

Study leader's E-mail:

rebrcca@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:

北京市海淀区复兴路28号 

研究负责人通讯地址:

北京市海淀区复兴路28号 

Applicant address:

28 Fuxing Road, Haidian District, Beijing, China 

Study leader's address:

28 Fuxing Road, Haidian District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100853 

研究负责人邮政编码:

Study leader's postcode:

100853 

申请人所在单位:

中国人民解放军总医院 

Applicant's institution:

Chinese PLA General Hospital 

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:

(2020)伦审第001号 

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:

中国人民解放军总医院伦理委员办公室,武汉火神山医院伦理委员办公室,重庆市公共卫生医疗救治中心伦理委员会办公室 

Name of the ethic committee:

Ethics Committee Office of the Chinese people's Liberation Army General Hospital, Ethics Committee Office of Wuhan huoshenshan hospital,EthicsCommittee Office of Chongqing Public Health Medical Center 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-28 

伦理委员会联系人:

曹江 

Contact Name of the ethic committee:

Cao Jiang 

伦理委员会联系地址:

北京市海淀区复兴路28号 

Contact Address of the ethic committee:

28 Fuxing Road, Haidian District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010-66937166 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

301irb@sina.com 

研究实施负责(组长)单位:

中国人民解放军总医院 

Primary sponsor:

Chinese PLA General Hospital 

研究实施负责(组长)单位地址:

北京市海淀区复兴路28号 

Primary sponsor's address:

28 Fuxing Road, Haidian District, Beijing, 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):

北京

市(区县):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

中国人民解放军总医院

具体地址:

北京市海淀区复兴路28号

Institution
hospital:

Chinese PLA General Hospital

Address:

28 Fuxing Road, Haidian District

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):

武汉火神山医院

具体地址:

Institution
hospital:

Wuhan Huoshenshan Hospital

Address:

国家:

中国

省(直辖市):

重庆

市(区县):

重庆

Country:

China

Province:

Chongqing

City:

Chongqing

单位(医院):

重庆市公共卫生医疗救治中心

具体地址:

重庆市沙坪坝区歌乐山保育路109号

Institution
hospital:

Chongqing Public Health Medical Center

Address:

109 Baoyu Road

经费或物资来源:

北京华科泰生物技术股份有限公司 

Source(s) of funding:

Beijing Savant Biotechnology Co., Ltd. 

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:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本次临床试验通过试验试剂对来自临床病例样本的检测结果与临床上新型冠状病毒感染的肺炎诊断标准及疾病进程的判定结果作为对比方法进行比较研究,同时与诊断所用核酸检测结果比较研究。计算临床灵敏度、临床特异度、置信区间,以验证产品的临床性能。 

Objectives of Study:

In this clinical trial, the test results from clinical case samples were compared with the diagnostic criteria of pneumonia and the determination of the disease course of clinical novel coronavirus by test reagent. Meanwhile, the results were compared with the nucleic acid test results used in the diagnosis.The clinical sensitivity, clinical specificity and confidence interval were calculated to verify the clinical performance of the product. 

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)样本信息齐全,包括样本编号、性别、年龄、采样时间、临床诊断背景信息; (2)新型冠状病毒感染的肺炎确诊病例(包括部分恢复期病例)、排除病例等(确诊病例应包括不同疾病进程的患者(如发病初期、中期、治疗后期/恢复期患者等); (3)纳入部分新型冠状病毒感染的肺炎患者不同时间采集的连续样本,包含该病例新型冠状病毒核酸和抗原/抗体由阴性转为阳性的各阶段样本; (4)样本选择为因临床需要检测本项目的住院患者、门诊患者。可以为临床单位检测的剩余样本,也可为临床单位检测的留存冻存样本。 

Inclusion criteria

(1)Complete sample information, including sample number, gender, age, sampling time, and clinical diagnosis background information (2)New coronavirus-infected pneumonia confirmed cases (including partial recovery cases), excluded cases, etc. (Confirmed cases should include patients with different disease processes (such as early, middle, late treatment / recovery patients, etc.) (3)Consecutive samples collected at different times from some patients with pneumonitis infected by the new coronavirus were included, including samples from each stage of the new coronavirus nucleic acid and antigen / antibody from negative to positive (4)The samples were selected as inpatients and outpatient patients for clinical needs.The remaining samples can be tested by clinical units or stored as frozen samples. 

排除标准:

(1)样本收集时间或信息不明确; (2)试验操作中因失误导致样本量不足检测者; (3)污染的样本。 

Exclusion criteria:

(1)Unclear sample collection time or information (2)Insufficient sample size due to mistakes in the test operation (3)Contaminated sample. 

研究实施时间:

Study execute time:

From2020-04-07To 2020-05-31 

征募观察对象时间:

Recruiting time:

From2020-04-21To 2020-05-31 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

临床结局;核酸检测

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

clinical outcome; nucleic acid test

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

抗原试剂

Index test:

antigen reagent

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

新型冠状病毒感染的肺炎确诊病例(包括部分恢复期病例)、排除病例等(确诊病例应包括不同疾病进程的患者(如发病初期、中期、治疗后期/恢复期患者等);纳入部分新型冠状病毒感染的肺炎患者不同时间采集的连续样本,包含该病例新型冠状病毒核酸和抗原/抗体由阴性转为阳性的各阶段样本;

例数:

Sample size:

600

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

New coronavirus-infected pneumonia confirmed cases (including partial recovery cases), excluded cases, etc. (Confirmed cases should include patients with different disease processes (such as early, middle, late treatment / recovery patients, etc.); Consecutive samples collected at different times from some patients with pneumonitis

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

中国人民解放军总医院 

单位级别:

三甲医院 

Institution
hospital:

Chinese PLA General Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

武汉市 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉火神山医院 

单位级别:

三甲医院 

Institution
hospital:

Wuhan huoshenshan hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

重庆 

市(区县):

重庆 

Country:

China 

Province:

Chongqing 

City:

Chongqing 

单位(医院):

重庆市公共卫生医疗救治中心 

单位级别:

 

Institution
hospital:

Chongqing Public Health Medical Center  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

新型冠状病毒核衣壳(N)抗原

指标类型:

主要指标 

Outcome:

new coronavirus nucleocapsid (N) antigen

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SEN, SPE, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, AUC of ROC

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:

咽拭子

组织:

Sample Name:

throat swab

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 10 years
最大 Max age 90 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):

N/A

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

N/A

盲法:

单盲法

Blinding:

Single blinding

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

Yes

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):

2020.8.30,提交国家药品监督管理局

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

2020.8.30,The data shall be submitted to National Medical Products Administration

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:

病例记录表;电子采集和管理系统

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

Case Record Form;Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-04-07
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