Today is 2020-12-01

Effectiveness and safety of hydroxychloroquine sulfate in the preventive treatment of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000031174 

最近更新日期:

Date of Last Refreshed on:

2020-05-04 

注册时间:

Date of Registration:

2020-03-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

夏露医师:该研究尚未获得伦理委员会批准。请于批准后才开始纳入参试者,并与我们联系上传批件。 硫酸羟氯喹预防性治疗新型冠状病毒肺炎(COVID-19)的有效性和安全性 

Public title:

Effectiveness and safety of hydroxychloroquine sulfate in the preventive treatment of novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

硫酸羟氯喹预防性治疗新型冠状病毒肺炎(COVID-19)的有效性和安全性 

Scientific title:

Effectiveness and safety of hydroxychloroquine sulfate in the preventive treatment of novel coronavirus pneumonia (COVID-19) 

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:

Xia Lu 

Study leader:

Lu Shuihua 

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:

tuberculosis@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号结核科医生办公室 

研究负责人通讯地址:

上海市金山区漕廊公路2901号结核科医生办公室 

Applicant address:

2901 Caolang Road, Jinshan District, Shanghai 

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中心 

Applicant's institution:

Shanghai Public Health Clinical Center 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

上海市公共卫生临床中心 

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):

上海市公共卫生临床中心

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

经费或物资来源:

上海市重点学科建设,感染病学科建设,结核病方向;“十三五”重大专项 

Source(s) of funding:

Shanghai Key Discipline Construction-Infectious Diseases Discipline Construction, TB Direction; Major Projects in the 13th Five-Year Plan 

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:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

评估硫酸羟氯喹预防性治疗新型冠状病毒感染的肺炎的有效性和安全性。  

Objectives of Study:

To evaluate the effectiveness and safety of hydroxychloroquine sulfate in the prophylactic treatment of new coronavirus infections. 

药物成份或治疗方案详述:

本研究为随机、双盲、对照研究,选取在COVID-19高流行地区湖北省各大社区中选1000例受试者,按照中心随机方案,将所有受试者分为2组,1组为对照组,1组为试验组,对照组予安慰剂,每次4片,口服,每次1片,治疗组予羟氯喹,每次4片,口服,每次1片,疗程5日,治疗前、治疗后、1月后分别采集咽拭子,痰液以及外周血10ml,行核酸检测及抗体检测。 

Description for medicine or protocol of treatment in detail:

This study is a randomized, double-blind, controlled study. 1000 subjects were selected from each of the major communities in Hubei Province where COVID-19 is highly prevalent, and all subjects were divided according to the central randomized scheme. There were 2 groups, 1 group was the control group, 1 group was the experimental group, the control group was given placebo, 4 tablets each time, orally, 1 tablet each time, and the treatment group was given hydroxychloroquine, 4 tablets each time, orally 1 tablet each time. Tablets, the course of treatment was 5 days, and throat swabs, sputum, and peripheral blood 10ml were collected before treatment, after treatment, and after 1 month for nucleic acid detection and antibody detection. 

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; (3) Sign the informed consent and volunteer to participate in this study. 

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) Women during pregnancy; (3) Patients with heart, lung, kidney, brain, blood and other important organs with severe diseases accompanied by insufficiency; (4) Patients with retinal disease, hearing loss or hearing loss; (5) Patients with severe neurological and mental illness; (6) Subjects who the investigator believes cannot complete the study as required, or is not suitable to participate in the study. 

研究实施时间:

Study execute time:

From2020-03-23To 2020-09-30 

征募观察对象时间:

Recruiting time:

From2020-03-23To 2020-07-30 

干预措施:

Interventions:

组别:

2组

样本量:

1000

Group:

Experimental group vs control group

Sample size:

干预措施:

羟氯喹vs安慰剂

干预措施代码:

Intervention:

Hydroxychloroquine versus Placebo

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(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市公共卫生临床中心 

单位级别:

三甲医院 

Institution
hospital:

Shanghai Public Health Clinical Center  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

新冠病毒核酸

指标类型:

主要指标 

Outcome:

COVID-19 Nucleic acid

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:

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 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:

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:

病例记录表

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:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-03-23
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