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硫酸羟氯喹对新型冠状病毒肺炎(COVID-19)高流行社区和低流行社区的预防作用研究
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注册号:

Registration number:

ChiCTR2000032487 

最近更新日期:

Date of Last Refreshed on:

2020-04-29 

注册时间:

Date of Registration:

2020-04-29 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

硫酸羟氯喹对新型冠状病毒肺炎(COVID-19)高流行社区和低流行社区的预防作用研究  

Public title:

Study for using sulfate in the prevention and control of novel coronavirus pneumonia (COVID-19) in high and low prevalence communities 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

硫酸羟氯喹对新型冠状病毒肺炎(COVID-19)高流行社区和低流 行社区的预防作用研究  

Scientific title:

Study for using sulfate in the prevention and control of novel coronavirus pneumonia (COVID-19) in high and low prevalence communities 

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:

夏露 

研究负责人:

卢水华 

Applicant:

Lu Xia 

Study leader:

Shuihua Lu 

申请注册联系人电话:

Applicant telephone:

+86 18121155957 

研究负责人电话:

Study leader's telephone:

+86 18930811818 

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:

hello0410@126.com 

研究负责人电子邮件:

Study leader's E-mail:

lushuihua@shphc.org.cn 

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:

上海市金山区漕廊公路2901号 

研究负责人通讯地址:

上海市金山区漕廊公路2901号 

Applicant address:

2901 Caolang Road, Jinshan District, Shanghai, China 

Study leader's address:

2901 Caolang Road, Jinshan District, Shanghai 

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:

上海市公共卫生临床卫生中心 

Applicant's institution:

Shanghai Public Health Clinical Center 

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-S063-01 

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:

上海公共卫生临床中心伦理委员会 

Name of the ethic committee:

Ethics Committee of Shanghai Public Health Clinical Center 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-26 

伦理委员会联系人:

刘晓茜 

Contact Name of the ethic committee:

Xiaoqian Liu 

伦理委员会联系地址:

上海市金山区漕廊公路2901号 

Contact Address of the ethic committee:

2901 Caolang Road, Jinshan District, Shanghai, 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:

上海公共卫生临床中心 

Primary sponsor:

Shanghai Public Health Clinical Center 

研究实施负责(组长)单位地址:

上海市金山区漕廊公路2901号 

Primary sponsor's address:

2901 Caolang Road, Jinshan 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):

上海公共卫生临床中心

具体地址:

上海市金山区漕廊公路2901号

Institution
hospital:

Shanghai Public Health Clinical Center

Address:

2901 Caolang Road, Jinshan District, Shanghai

经费或物资来源:

科研经费 

Source(s) of funding:

Research funds 

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:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

初步评估硫酸羟氯喹对新型冠状病毒感染的肺炎高流行地区和低流行地区的社区人群预防性治疗的有效性。 

Objectives of Study:

Novel coronavirus sulfate is a useful tool for the prevention of new coronavirus infection in the high prevalence and low prevalence areas of the community. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)COVID-19核酸检测及抗体检测阴性的健康受试者; (2)年龄18-70岁; (3)签署知情同意书,自愿参加本研究。 

Inclusion criteria

1. Healthy subjects with negative covid-19 nucleic acid test and antibody test; 2. Aged 18-70 years old; 3. Signed informed consent and participated in the study voluntarily. 

排除标准:

(1)对氯喹、羟氯喹过敏患者; (2)妊娠期妇女; (3)合并心、肺、肾、脑、血液等重要脏器严重疾病伴功能不全患者; (4)患者视网膜疾病、听力减退或听力丧失的患者; (5)严重神经及精神疾病的患者; (6)研究者认为无法按要求完成研究、或不适宜参与研究的受试者。 

Exclusion criteria:

1. Patients allergic to chloroquine and hydroxychloroquine; 2. Pregnant women; 3. Patients with severe diseases of heart, lung, kidney, brain, blood and other important organs and dysfunction; 4. Patients with retinopathy, hearing loss or hearing loss; 5. Patients with severe neurological and psychiatric diseases; 6. Subjects who, in the opinion of the investigator, were unable to complete the study as required or were not suitable to participate in the study. 

研究实施时间:

Study execute time:

From2020-03-01To 2020-09-30 

征募观察对象时间:

Recruiting time:

From2020-03-26To 2020-08-31 

干预措施:

Interventions:

组别:

试验组

样本量:

1000

Group:

Experimental group

Sample size:

干预措施:

给与硫酸羟氯喹

干预措施代码:

Intervention:

Administration of hydroxychloroquine sulfate

Intervention code:

组别:

对照组

样本量:

1000

Group:

control group

Sample size:

干预措施:

给予安慰剂

干预措施代码:

Intervention:

Placebo given

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):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉金银滩医院 

单位级别:

三甲医院 

Institution
hospital:

Wuhan Jinyintan hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

新冠病毒核酸检测及抗体检测

指标类型:

主要指标 

Outcome:

Detection of nucleic acid and antibody of new coronavirus

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:

标本中文名:

痰液

组织:

Sample Name:

sputum

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:

外周血

组织:

Sample Name:

Peripheral 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 70 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):

分层区组随机化

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

stratified block randomization

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

2020年12月上传数据库

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

Upload database in December 2020

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:

病历记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-04-29
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