Today is 2020-10-31

Clinical Study of Arbidol Hydrochloride Using for Post-exposure Prophylaxis of 2019-nCoV in High-risk Population Including Medical Staff
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注册号:

Registration number:

ChiCTR2000029592 

最近更新日期:

Date of Last Refreshed on:

2020-03-16 

注册时间:

Date of Registration:

2020-02-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

盐酸阿比多尔用于医务人员等高暴露风险人群新型冠状病毒暴露后预防的临床研究 

Public title:

Clinical Study of Arbidol Hydrochloride Using for Post-exposure Prophylaxis of 2019-nCoV in High-risk Population Including Medical Staff 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

盐酸阿比多尔用于医务人员等高暴露风险人群新型冠状病毒暴露后预防的临床研究 

Scientific title:

Clinical Study of Arbidol Hydrochloride Using for Post-exposure Prophylaxis of 2019-nCoV in High-risk Population Including Medical Staff 

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:

王宝菊 

研究负责人:

郑昕 

Applicant:

Baoju Wang 

Study leader:

Xin Zheng 

申请注册联系人电话:

Applicant telephone:

+86 13627288476 

研究负责人电话:

Study leader's telephone:

+86 027 85726732 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+86 027 85726398 

申请注册联系人电子邮件:

Applicant E-mail:

bjwang73@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xin11@hotmail.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:

湖北省武汉市解放大道1277号 

研究负责人通讯地址:

湖北省武汉市解放大道1277号 

Applicant address:

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei, China 

Study leader's address:

1277 Jiefang Avenue, Jianghan District, 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:

[2020]伦审字(0056)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:

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:

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:

2020-02-28 

伦理委员会联系人:

吴建才 

Contact Name of the ethic committee:

Jiancai Wu 

伦理委员会联系地址:

湖北省武汉市解放大道1277号 

Contact Address of the ethic committee:

277 Jiefang Avenue, Jianghan District, Wuhan, Hubei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 027-85726685 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

whunionlunli@126.com 

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):

华中科技大学同济医学院附属协和医院

具体地址:

湖北省武汉市解放大道1277号

Institution
hospital:

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

Address:

1277 Jiefang Avenue, Jianghan District

经费或物资来源:

华中科技大学新型冠状病毒肺炎应急科技攻关专项课题(2020kfyXGYJ046) 

Source(s) of funding:

HUST COVID-19 Rapid Response Call (2020kfyXGYJ046) 

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:

上市后药物 

Study phase:

研究目的:

建立医务工作者等高暴露风险人群队列,通过系统收集暴露数据和人群随访,分析研究盐酸阿比多尔对新型冠状病毒暴露后医务人群等高风险人群的病毒核酸阳性率、病毒抗体阳性率、发病率、重型/危重型肺炎发生率的影响及其安全性,为阿比多尔用于新型冠状病毒暴露后高风险人群的预防提供证据。 

Objectives of Study:

Establish a cohort of high-risk population including medical staff who was exposed to 2019-nCoV, systematically collect the exposure data and the following events including taking antiviral drugs including Arbidol, the appearance of clinical manifestation, abnormal laboratory tests and chest CT imaging, viral RNA and antibodies against 2019-nCoV, and analyze the efficacy and safety of Arbidol hydrochloride for 2019-nCoV post-exposure prophylaxis. 

药物成份或治疗方案详述:

盐酸阿比多尔是俄罗斯研发的小吲哚衍生物分子,在俄罗斯和中国被批准为流感和其他呼吸道病毒的预防(仅在俄罗斯)和治疗用药。 此研究为问卷调查,不涉及用药方案。 

Description for medicine or protocol of treatment in detail:

Arbidol hydrochloride is a small indole derivative molecule developed in Russia and approved in Russia and China for the prevention (only in Russia) and treatment of influenza and other respiratory viruses. This study was a questionnaire survey and treatment regimens is not applicable. 

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:

新型冠状病毒肺炎暴发期间在岗的医务人员等高暴露风险人群。 

Inclusion criteria

High-risk population including medical staff on duty during the outbreak of 2019-nCoV pneumonia. 

排除标准:

1. 不愿意参与此项调查研究的医务工作者; 2. 研究期间,中途想退出研究的医务工作者。 

Exclusion criteria:

1. People with high-risk exposure who are unwilling to participate in this survey; 2. People with high-risk exposure who want to withdraw from the research during the study. 

研究实施时间:

Study execute time:

From2020-02-05To 2020-08-31 

征募观察对象时间:

Recruiting time:

From2020-02-07To 2020-08-31 

干预措施:

Interventions:

组别:

Two cohorts

样本量:

1000

Group:

Two cohorts

Sample size:

干预措施:

阿比多尔使用史vs无阿比多尔使用史

干预措施代码:

Intervention:

Arbidol cohort versus without Arbidol cohort

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):

华中科技大学同济医学院附属协和医院 

单位级别:

三级甲等 

Institution
hospital:

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

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

新型冠状病毒核酸

指标类型:

主要指标 

Outcome:

2019-nCoV RNA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新型冠状病毒抗体

指标类型:

主要指标 

Outcome:

2019-nCoV antibody

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部CT

指标类型:

主要指标 

Outcome:

Chest CT

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 65 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):

不涉及随机化处理

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

Not Available

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):

以论文的形式提交;通过中国知网查询

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

IPD will be public accessable via CNKI; Submit in the form of paper

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:

病例报告表 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:

CRF、EDC

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-02-05
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