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磷酸氯喹对新型冠状病毒肺炎(COVID-19)治疗的多中心、单盲、随机对照临床试验
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注册号:

Registration number:

ChiCTR2000031204 

最近更新日期:

Date of Last Refreshed on:

2020-03-24 

注册时间:

Date of Registration:

2020-03-24 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

磷酸氯喹对新型冠状病毒肺炎(COVID-19)治疗的多中心、单盲、随机对照临床试验 

Public title:

A multicenter, single-blind, randomized controlled clinical trial for chloroquine phosphate in the 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:

磷酸氯喹对2019新型冠状病毒感染肺炎治疗的多中心、单盲、随机对照临床试验 

Scientific title:

A multicenter, single-blind, randomized controlled clinical trial for chloroquine phosphate in the treatment of 2019 novel coronavirus-infected pneumonia 

研究课题代号(代码):

Study subject ID:

JYCO 

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:

钟武 

研究负责人:

金荣华 

Applicant:

Zhong Wu 

Study leader:

Jin Ronghua 

申请注册联系人电话:

Applicant telephone:

+86 010-66932624 

研究负责人电话:

Study leader's telephone:

+86 13901374552 

申请注册联系人传真 :

Applicant Fax:

+86 010-68240321 

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:

zhongwu@bmi.ac.cn 

研究负责人电子邮件:

Study leader's E-mail:

jin_eagle@sina.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:

北京市海淀区太平路27号院 

研究负责人通讯地址:

北京市丰台区右安门外西头条8号 

Applicant address:

27 Taiping Road, Haidian District, Beijing, China 

Study leader's address:

8 Xi-Tou-Tiao Lane West, You'anmen Street, Fengtai District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100850 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

军事医学研究院毒物药物研究所 

Applicant's institution:

Beijing Institute of Pharmacology and Toxicology 

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:

京佑科伦字【2020】006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:

首都医科大学附属北京佑安医院伦理委员会 

Name of the ethic committee:

Ethics committee of Beijing You'an Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-30 

伦理委员会联系人:

盛艾娟 

Contact Name of the ethic committee:

Sheng Aijuan 

伦理委员会联系地址:

北京市丰台区右安门外西头条8号 

Contact Address of the ethic committee:

8 Xi-Tou-Tiao Lane West, You'anmen Street, Fengtai District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010-83997028 

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:

首都医科大学附属北京佑安医院 

Primary sponsor:

Beijing you'an Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市丰台区右安门外西头条8号 

Primary sponsor's address:

8 Xi-Tou-Tiao Lane West, You'anmen Street, Fengtai District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

军事医学研究院毒物药物研究所

具体地址:

北京市海淀区太平路27号院

Institution
hospital:

Beijing institute of pharmacology and toxicology

Address:

27 Taiping Road, Haidian District

经费或物资来源:

科技部重大新药创制专项 

Source(s) of funding:

The National Science and Technology Major Projects for  

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:

II期临床试验 

Study phase:

研究目的:

评估磷酸氯喹对新型冠状病毒感染肺炎的有效性及安全性。 

Objectives of Study:

To evaluate the efficacy and safety of chloroquine phosphate against pneumonia caused by novel coronavirus. 

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:

● 男性及女性,18岁-70岁 ● 2019新型冠状病毒核酸检测阳性 ● 临床诊断为肺炎 ● 发病7天以内(重型者可延至14天以内), ● 本人或委托代理人签署知情同意书 ● 可以口服用药或者接受口服用药的受试者 ● 同意收集临床样本 ● 育龄女性受试者未怀孕,且同意在最后一次口服药物7天内采取有效避孕措施,确保不怀孕 ● 男性同意在最后一次口服药物7天内不与妇女进行性交 

Inclusion criteria

1. male and female aged 18-70 years; 2. positive result of test for 2019 novel coronavirus nucleic acid; 3. Clinical diagnosed with pneumonia; 4. onset within 7 days (severe cases can be delayed to 14 days); 5. the informed consent shall be signed by me or the authorized agent; 6. subjects who can take oral medication or who receive oral medication; 7. agree to collect clinical samples; 8. female subjects of child-bearing age are not pregnant and agree to take effective contraceptive measures within 7 days of the last oral medication to ensure that they are not pregnant; 9. men agree not to have sex with women for seven days after their last oral medication. 

排除标准:

● 出现严重呕吐且难以口服药物或导致口服后药物难以摄取的病例 ● 孕妇以及哺乳期妇女 ● 受试者在入院前一周内接受过洛匹那韦/利多那韦、利巴韦林、单克隆抗体等特异性抗病毒药物治疗 ● 呼吸衰竭且需要机械通气的病例 ● 出现休克的病例 ● 合并其他器官功能衰竭需ICU监护治疗 ● 临床预判无生存希望,仅进行临终关怀的病例,或者深度昏迷且在入院三小时内对支持治疗措施无反应的病例 

Exclusion criteria:

1. severe vomiting and difficulty in taking oral medication or in taking oral medication; 2. pregnant and nursing women; 3. subjects received lopinavir/ridonavir, ribavirin, monoclonal antibodies and other specific antiviral drugs in the week prior to admission; 4. cases of respiratory failure requiring mechanical ventilation; 5. cases of shock; 6. combined with other organ failure requires intensive care unit; 7. patients with no clinical expectation of survival and only end-of-life care, or those in a deep coma who did not respond to supportive treatment within three hours of admission. 

研究实施时间:

Study execute time:

From2020-01-30To 2020-04-30 

征募观察对象时间:

Recruiting time:

From2020-01-30To 2020-03-31 

干预措施:

Interventions:

组别:

实验治疗组

样本量:

150

Group:

Experimental treatment group

Sample size:

干预措施:

口服受试药磷酸氯喹片(治疗组)

干预措施代码:

Intervention:

Oral chloroquine phosphate tablets (treatment group)

Intervention code:

组别:

对照组

样本量:

150

Group:

control group

Sample size:

干预措施:

口服安慰剂治疗组(对照组)

干预措施代码:

Intervention:

Oral placebo group (control group)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京佑安医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing you 'an hospital, capital medical university  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第一医院 

单位级别:

三甲医院 

Institution
hospital:

Peking University First Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京回民医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing huimin hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

病毒核酸检测阳性转阴性的天数

指标类型:

主要指标 

Outcome:

Clearance time of virus 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:

进展为重症的比率

指标类型:

次要指标 

Outcome:

Rate of progression to severe case

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发热持续时间

指标类型:

次要指标 

Outcome:

Duration of fever

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

外周血C反应蛋白浓度

指标类型:

次要指标 

Outcome:

Diagnosis value of C-reactive protein

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

外周血淋巴细胞绝对值及百分率

指标类型:

次要指标 

Outcome:

Absolute value and percentage of peripheral blood lymphocytes

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部影像学改善时间

指标类型:

次要指标 

Outcome:

Lung image features improving time

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:

外周静脉血

组织:

Sample Name:

Peripheral Venous Blood

Tissue:

人体标本去向

使用后保存 

说明

剩余样本保存至-80度

Fate of sample:

Preservation after use 

Note:

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:

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 years
最大 Max age 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):

项目组研究人员通过EXCEL生成的随机数字表,按照随机数字的奇数和偶数分组,奇数为实验组,偶数为对照组。

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

The researchers in the project team used EXCEL to generate a table of random Numbers, which were divided into two groups according to the odd and even Numbers of random Numbers, with odd Numbers as the experimental group and even Numbers as the control group.

盲法:

单盲

Blinding:

Single blind

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):

向研究者索要结果

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

Ask the researchers for the results

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:

CRF和EDC

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

CRF and EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-24
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