Today is 2020-02-29

A prospective, open-label, multiple-center study for the efficacy of chloroquine phosphate in patients with novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000029609 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

磷酸氯喹治疗2019新型冠状病毒肺炎(COVID-19)疗效的前瞻性、开放性、多中心临床研究 

Public title:

A prospective, open-label, multiple-center study for the efficacy of chloroquine phosphate 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、开放性评价磷酸氯喹治疗2019新型冠状病毒肺炎(COVID-19)疗效的多中心临床研究 

Scientific title:

A prospective, open-label, multiple-center study for the efficacy of chloroquine phosphate 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:

黄明星 

研究负责人:

单鸿 

Applicant:

Mingxing Huang 

Study leader:

Hong Shan 

申请注册联系人电话:

Applicant telephone:

+86 15989778816 

研究负责人电话:

Study leader's telephone:

+86 0756 2528573 

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:

huangmx5@mail.sysu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

shanhong@mail.sysu.edu.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:

广东省珠海市梅华东路52号 

研究负责人通讯地址:

广东省珠海市梅华东路52号 

Applicant address:

52 Meihua Road East, Zhuhai, Guangdong, China 

Study leader's address:

52 Meihua Road East, Zhuhai, Guangdong, China 

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:

中山大学附属第五医院 

Applicant's institution:

The Fifth Affiliated 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:

中大五院【2020】伦字第(K14-1)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:

中山大学附属第五医院医学伦理委员会 

Name of the ethic committee:

Medical Ethic Committee of the Fifth Affiliated Hospital of Sun Yat-Sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-05 

伦理委员会联系人:

傅雪婷 

Contact Name of the ethic committee:

Xueting Fu 

伦理委员会联系地址:

广东省珠海市梅华东路52号 

Contact Address of the ethic committee:

52 Meihua Road East, Zhuhai, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0756-2528895 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

zdwyllwyh@163.com 

研究实施负责(组长)单位:

中山大学附属第五医院 

Primary sponsor:

The Fifth Affiliated Hospital of Sun Yat-Sen University 

研究实施负责(组长)单位地址:

广东省珠海市梅华东路52号 

Primary sponsor's address:

52 Meihua Road East, Zhuhai, 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):

珠海

Country:

China

Province:

Guangdong

City:

Zhuhai

单位(医院):

中山大学附属第五医院

具体地址:

广东省珠海市梅华东路52号

Institution
hospital:

The Fifth Affiliated Hospital of Sun Yat-Sen University

Address:

52 Meihua Road East, Zhuhai

经费或物资来源:

自筹 

Source(s) of funding:

Self fund-raising 

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:

探讨磷酸氯喹对2019新型冠状病毒肺炎的疗效及安全性 

Objectives of Study:

To evaluate the efficacy and safety of chloroquine phosphate in hospitalized patients with 2019 novel coronavirus pneumonia. 

药物成份或治疗方案详述:

1. 磷酸氯喹片,0.25g/片,每片含氯喹0.155g 2. 洛匹那韦/利托那韦,每片含洛匹那韦200mg,利托那韦100mg 

Description for medicine or protocol of treatment in detail:

1. Chloroquine phosphate tablet, 0.25 gram per pill, which contains chloroquine 0.155 gram; 2. Lopinavir/ritonavir tablet, each pill containing lopinavir 200mg and ritonavir 100mg 

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. 符合国家卫生健康委员会诊疗指南第5版的确诊病例定义。详细条目见:http://www.nhc.gov.cn/yzygj/s7653p/202002/3b09b894ac9b4204a79db5b8912d4440.shtml 

Inclusion criteria

1. Aged >=18 years old; 2. Patients has been diagnosed with 2019-nCoV pneumonia according to the fifth version of 2019-nCoV pneumonia management guideline made by the national health commission of the People's Repulic of China. More details see: http://www.nhc.gov.cn/yzygj/s7653p/202002/3b09b894ac9b4204a79db5b8912d4440.shtml 

排除标准:

1.处于妊娠期的女性患者; 2.明确对磷酸氯喹类、洛匹那韦、利托那韦药物过敏史的患者; 3.患有血液系统疾病的患者; 4.患有慢性肝、肾疾病并达到终末期的患者; 5.患有心律失常、慢性心脏病的患者; 6.已知患有视网膜疾病、听力减退或听力丧失的患者; 7.已知患有精神类疾病的患者; 8.因原有基础疾病必须使用洋地黄类药物的患者; 9.胰腺炎; 10.血友病; 11.蚕豆病。 

Exclusion criteria:

1. Pregnant woman patients; 2. Documented allergic history to any of chloroquine phosphate, ritonavir and lopinavir; 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; 9. Onging pancreatitis; 10. Documented history of hemophilia; 11. Documented history of glucose-6 phosphate dehydrogenase (G-6-PD) deficiency. 

研究实施时间:

Study execute time:

From2020-02-10To 2020-12-31 

干预措施:

Interventions:

组别:

轻型-普通型-磷酸氯喹组

样本量:

59

Group:

mild-moderate chloroquine group

Sample size:

干预措施:

口服磷酸氯喹片

干预措施代码:

Intervention:

oral chloroquine phosphate

Intervention code:

组别:

轻型-普通型-洛匹/利托组

样本量:

59

Group:

mild-moderate Lopinavir/ritonavir group

Sample size:

干预措施:

口服洛匹那韦/利托那韦

干预措施代码:

Intervention:

oral Lopinavir/ritonavir

Intervention code:

组别:

轻型-普通型 联合组

样本量:

59

Group:

mild-moderate combination group

Sample size:

干预措施:

口服磷酸氯喹及洛匹那韦/利托那韦

干预措施代码:

Intervention:

chloroquine phosphate plus Lopinavir/ritonavir

Intervention code:

组别:

重型-磷酸氯喹组

样本量:

14

Group:

severe-chloroquine group

Sample size:

干预措施:

口服磷酸氯喹片

干预措施代码:

Intervention:

oral chloroquine phosphate

Intervention code:

组别:

重型-洛匹/利托组

样本量:

14

Group:

severe- Lopinavir/ritonavir group

Sample size:

干预措施:

口服洛匹那韦/利托那韦

干预措施代码:

Intervention:

oral Lopinavir/ritonavir

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 of Sun Yat-sen University  

Level of the institution:

Tertiary Hospital 

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 

单位级别:

三级甲等 

Institution
hospital:

Sun Yat sen Memorial Hospital of Sun Yat sen University  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

病毒核酸检测转阴时间

指标类型:

主要指标 

Outcome:

virus nucleic acid 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:

28天全因死亡率

指标类型:

次要指标 

Outcome:

28-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:

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入住率

指标类型:

次要指标 

Outcome:

ICU admission ratio

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:

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:

尚未开始

Not yet 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):

本研究为非随机研究

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

No randomization

盲法:

Open label

Blinding:

Open label

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):

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:

 2020-02-06
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