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法匹拉韦片联合磷酸氯喹片治疗新型冠状病毒肺炎(COVID-19)的临床试验方案
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注册号:

Registration number:

ChiCTR2000030987 

最近更新日期:

Date of Last Refreshed on:

2020-03-20 

注册时间:

Date of Registration:

2020-03-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

法匹拉韦片联合磷酸氯喹片治疗新型冠状病毒肺炎(COVID-19)的临床试验方案 

Public title:

A Randomized Controlled Trial for Favipiravir Tablets Combine With 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:

法匹拉韦片联合磷酸氯喹片治疗新型冠状病毒肺炎(COVID-19)的临床试验方案 

Scientific title:

Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the 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:

王淑民 

研究负责人:

童朝晖 

Applicant:

Shumin Wang 

Study leader:

Zhaohui Tong 

申请注册联系人电话:

Applicant telephone:

+86 13488760399 

研究负责人电话:

Study leader's telephone:

+86 13910930309 

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:

shuminwang7000@163.com 

研究负责人电子邮件:

Study leader's E-mail:

tongzhaohuicy@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:

北京朝阳区工人体育场南路 8 号首都医科大学附属北京朝阳医院 

研究负责人通讯地址:

北京朝阳区工人体育场南路 8 号 

Applicant address:

8 Worker Stadium Road South, Chaoyang District, Beijing, China 

Study leader's address:

8 Worker Stadium Road South, Chaoyang District, Beijing, 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:

北京朝阳医院 

Applicant's institution:

Beijing Chao-yang Hospital 

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-科-24-2 

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:

北京朝阳医院伦理委员会 

Name of the ethic committee:

Ethic committee of Beijing Chao-yang Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-08 

伦理委员会联系人:

吕亚丽 

Contact Name of the ethic committee:

Yali Lv 

伦理委员会联系地址:

北京朝阳区工人体育场南路 8 号北京朝阳医院伦理委员会 

Contact Address of the ethic committee:

Ethic committee of Beijing Chao-yang Hospital, Capital Medical University, 8 Worker Stadium Road South, Chaoyang District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

85231484 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

cyylunli2019@163.com 

研究实施负责(组长)单位:

北京朝阳医院 

Primary sponsor:

Beijing Chao-yang Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京朝阳区工人体育场南路 8 号首都医科大学附属北京朝阳医院 

Primary sponsor's address:

8 Worker Stadium Road South, Chaoyang 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):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

北京朝阳医院

具体地址:

北京朝阳区工人体育场南路 8 号首都医科大学附属北京朝阳医院

Institution
hospital:

Beijing Chao-yang Hospital

Address:

8 Worker Stadium Road South, Chaoyang District

经费或物资来源:

科技部重大专项 

Source(s) of funding:

Major projects of the ministry of science and technology 

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-III期临床试验 

Study phase:

2-3 

研究目的:

评估法匹拉韦片联合磷酸氯喹片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 familavir tablets combined with chloroquine phosphate tablets in the treatment of novel coronavirus pneumonia. 

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:

入组标准: 1.男性及女性,18 岁-75 岁 2.既往确诊为新型冠状病毒肺炎的患者:病程≦14 天直接入组;病程>14 天,符合下列条件之一也可入组:①7 天内胸部影像病变未见明显吸收,或有进展;②有呼吸道症状(胸闷,或咳嗽,或呼吸困难);③3 天内核酸阳性者 3.本人或委托代理人签署知情同意书 4.同意收集临床样本 5.育龄女性受试者或男性受试者同意在最后一次口服药物 3 个月内采取有效避孕措施,确保育龄女性受试者或男性受试者伴侣不怀孕 

Inclusion criteria

1. Male and female aged 18-75 years old; 2. Patients previously diagnosed with COVID-2019: the course of illness is no more than 14 days;If the course of disease was more than 14 days, patients meeting one of the following conditions could also be included: (1) no obvious absorption or progression of chest lesions within 7 days; (2) respiratory symptoms (chest tightness, or cough, or breathing difficulties); Nucleic acid positive within 3 days 3. sign the informed consent; 4. Agree to collect clinical samples; 5. Female or male subjects of childbearing age agree to take effective contraceptive measures within 3 months of the last oral medication to ensure that female or male partners of childbearing age are not pregnant. 

排除标准:

排除标准: 1.出现严重呕吐或难以摄取药物的病例 2.孕妇以及哺乳期妇女 3.入组前 3 d 内接受过洛匹那韦/利多那韦、利巴韦林、干扰素、单克隆抗体特异性抗病毒药物治疗 4.呼吸衰竭且需要机械通气的病例 5.出现休克的病例 6.合并其他器官功能衰竭需 ICU 监护治疗 7.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. Cases of severe vomiting or difficulty in ingesting medication; 2. Pregnant and lactating women; 3. Lopinavir/ridonavir, ribavirin, interferon and monoclonal antibody were received 3 days before enrollment; 4. Cases of respiratory failure requiring mechanical ventilation; 5. Cases of shock; 6. Complications of other organ failure require ICU care; 7. Patients were clinically predicted with no hope of survival and only received hospice care, or those who were in a deep coma and did not respond to supportive treatment measures within three hours of admission. 

研究实施时间:

Study execute time:

From2020-03-05To 2020-06-25 

征募观察对象时间:

Recruiting time:

From2020-03-05To 2020-04-30 

干预措施:

Interventions:

组别:

口服受试药法匹拉韦片加磷酸氯喹片组(联合组)

样本量:

50

Group:

Experimental group 1

Sample size:

干预措施:

口服受试药法匹拉韦片加磷酸氯喹片

干预措施代码:

Intervention:

the oral trial drug favipiravir tablets plus chloroquine phosphatetablets tablets group

Intervention code:

组别:

口服法匹拉韦片组(法匹拉韦组)

样本量:

50

Group:

Experimental group 2

Sample size:

干预措施:

口服法匹拉韦片

干预措施代码:

Intervention:

the oral trial drug favipiravir tablets

Intervention code:

组别:

口服模拟剂治疗组 (对照组)

样本量:

50

Group:

Control group

Sample size:

干预措施:

口服模拟剂

干预措施代码:

Intervention:

the oral placebo treatment

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):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

北京朝阳医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing Chao-yang Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

呼吸道症状好转或恢复

指标类型:

主要指标 

Outcome:

improvement or recovery of respiratory symptoms

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咽拭子或痰液病毒核酸定量检测阳性转阴性的天数

指标类型:

主要指标 

Outcome:

viral nucleic acid shedding

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:

咽拭子和痰液

组织:

Sample Name:

throat swab or sputum

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 75 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

数字随机表

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

Random number table

盲法:

未说明

Blinding:

Not stated

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):

2020/12/31上传于中国临床试验注册中心的 ResMan 原始数据共享平台 (IPD 共享平台 )

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

ResMan

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(Case Record Form, CRF)

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-20
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