今天是:2020-04-08 星期三

氯喹对新型冠状病毒肺炎(COVID-19)的临床疗效评价
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注册号:

Registration number:

ChiCTR2000029542 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

氯喹对新型冠状病毒肺炎(COVID-19)的临床疗效评价 

Public title:

Study for the efficacy of chloroquine in patients with novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一项前瞻性评价氯喹治疗新型冠状病毒(COVID-19)感染住院患者临床疗效及安全性的队列研究 

Scientific title:

A prospective cohort study for the efficacy and safety of chloroquine in hospitalized patients with 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:

唐恬恬 

研究负责人:

江山平 

Applicant:

Tand Tiantian 

Study leader:

Jiang Shanping 

申请注册联系人电话:

Applicant telephone:

+86 18998362724 

研究负责人电话:

Study leader's telephone:

+86 13922738892 

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:

tangtt3@mail.sysu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

shanpingjiang@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:

广东省广州市沿江西路102号 

研究负责人通讯地址:

广东省广州市沿江西路102号 

Applicant address:

102 Yanjiang Road West, Guangzhou, Guangdong, China 

Study leader's address:

102 Yanjiang Road West, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510120 

研究负责人邮政编码:

Study leader's postcode:

510120 

申请人所在单位:

中山大学孙逸仙纪念医院 

Applicant's institution:

Sun Yat sen Memorial Hospital of Sun Yat sen University 

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-KY-009 

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:

中山大学孙逸仙纪念医院医学伦理委员会 

Name of the ethic committee:

Medical Ethic Committee of Sun Yat sen Memorial Hospital of Sun Yat sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-29 

伦理委员会联系人:

林双秀 

Contact Name of the ethic committee:

Lin Shuangxiu 

伦理委员会联系地址:

广东省广州市沿江西路102号 

Contact Address of the ethic committee:

102 Yanjiang Road West, Guangzhou, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 20 81332587 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

sysyxllwyh@163.com 

研究实施负责(组长)单位:

中山大学孙逸仙纪念医院 

Primary sponsor:

Sun Yat sen Memorial Hospital of Sun Yat sen University 

研究实施负责(组长)单位地址:

广东省广州市沿江西路102号 

Primary sponsor's address:

102 Yanjiang Road West, Guangzhou, Guangdong, 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):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学孙逸仙纪念医院

具体地址:

广东省广州市沿江西路102号

Institution
hospital:

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Address:

102 Yanjiang Road West, Guangzhou

经费或物资来源:

广州再生医学与健康广东省实验室 

Source(s) of funding:

Guangzhou Regenerative Medicine and Health Guangdong Laboratory (GRMH-GDL) 

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:

上市后药物 

Study phase:

研究目的:

评价氯喹治疗2019新型冠状病毒感染住院患者的有效性和安全性 

Objectives of Study:

To evaluate the efficacy and safety of chloroquine in hospitalized patients with 2019 novel coronavirus infections 

药物成份或治疗方案详述:

干预组:在常规治疗基础上联合氯喹治疗,方案:氯喹片,每天2次,每次0.5g,连续服用10天。 对照组:采取常规治疗。 

Description for medicine or protocol of treatment in detail:

For the intervention group, oral chloroquine will be given on the basis of conventional management: the dosage is 0.5 gram every time, twice a day for a 10-day course. For the control group, conventional treatment will be given. 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

①年龄≥18岁; ②符合WHO新型冠状病毒感染诊断标准*。 * WHO. Clinical management of severe acute respiratory infection when Novel coronavirus (nCoV) infection is suspected: interim guidance. Jan 11, 2020. https://www.who.int/internalpublications-detail/clinical-management-of-severe-acute-respiratoryinfection-when-novel-coronavirus-(ncov)-infection-is-suspected (accessed Jan 29, 2020). 

Inclusion criteria

1. Aged >=18 years old; 2. Patients has been diagnosed with 2019-nCoV pneumonia according to WHO interim guidance*. * WHO. Clinical management of severe acute respiratory infection when Novel coronavirus (nCoV) infection is suspected: interim guidance. Jan 11, 2020. https://www.who.int/internalpublications-detail/clinical-management-of-severe-acute-respiratoryinfection-when-novel-coronavirus-(ncov)-infection-is-suspected (accessed Jan 29, 2020). 

排除标准:

①年龄<18岁; ②处于妊娠期的女性患者; ③明确对氯喹类药物过敏史的患者; ④患有血液系统疾病的患者; ⑤患有慢性肝、肾疾病并达到终末期的患者; ⑥患有心律失常、慢性心脏病的患者; ⑦已知患有视网膜疾病、听力减退或听力丧失的患者; ⑧已知患有精神类疾病的患者; ⑨因原有基础疾病必须使用洋地黄类药物的患者。 

Exclusion criteria:

1. pregnant woman patients; 2. Documented allergic history to chloroquine; 3. Documented history of hematological system diseases; 4. Documented history of chronic liver and kidney diseases; 5. Documented history of cardiac arrhythmia or chronic heart diseases; 6. Documented history of retina or hearing dysfunction; 7. Documented history of mental illnesses; 8. Use of digitalis due to the previous disease. 

研究实施时间:

Study execute time:

From2020-02-03To 2020-07-30 

干预措施:

Interventions:

组别:

干预组

样本量:

10

Group:

Experimental group

Sample size:

干预措施:

氯喹

干预措施代码:

Intervention:

chloroquine

Intervention code:

组别:

对照组

样本量:

10

Group:

control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

conventional management

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

珠海 

Country:

China 

Province:

Guangdong 

City:

Zhuhai 

单位(医院):

中山大学附属第五医院 

单位级别:

三级甲等 

Institution
hospital:

The Fifth Affiliated Hospital, Sun Yat-sen University  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

病毒转阴时间

指标类型:

主要指标 

Outcome:

viral negative-transforming time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

30天病因死亡率

指标类型:

主要指标 

Outcome:

30-day cause-specific mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

30天全因死亡率

指标类型:

次要指标 

Outcome:

30-day all-cause mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

序贯器官衰竭评分

指标类型:

次要指标 

Outcome:

SOFA scoring

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

器官支持强度

指标类型:

次要指标 

Outcome:

organ support intensity

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

次要指标 

Outcome:

total length of hospitalization

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ICU入住时间

指标类型:

次要指标 

Outcome:

length of ICU stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

附加指标 

Outcome:

C-reactive protein

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎症因子

指标类型:

附加指标 

Outcome:

inflammatory cytokines

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能

指标类型:

副作用指标 

Outcome:

liver function

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件

指标类型:

副作用指标 

Outcome:

adverse events

Type:

Adverse events 

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:

标本中文名:

咽拭子

组织:

Sample Name:

oropharyngeal 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:

粪便

组织:

Sample Name:

stool

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:

正在进行

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):

本研究为非随机对照

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

No randomization

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

试验完成后6个月内共享在临床试验公共管理平台,网址:http://www.medresman.org.cn/login.aspx

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

The study data will be uploaded within six months after the trial compete on Clinical Trial Management Public Platform, http://www.medresman.org.cn/login.aspx

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:

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)。

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

A standard data collection and management system includes a CRF and an electronic data capture.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-03
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