Today is 2022-07-07

Randomized controlled trial for safety and efficacy of Favipiravir in the treatment of novel coronavirus pneumonia (COVID-19) with poorly responsive ritonavir/ritonavir
download

注册号:

Registration number:

ChiCTR2000030113 

最近更新日期:

Date of Last Refreshed on:

2020-02-24 

注册时间:

Date of Registration:

2020-02-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

法匹拉韦治疗洛匹那韦/利托那韦应答不佳的新型冠状病毒肺炎(COVID-19)患者的有效性与安全性的临床研究 

Public title:

Randomized controlled trial for safety and efficacy of Favipiravir in the treatment of novel coronavirus pneumonia (COVID-19) with poorly responsive ritonavir/ritonavir 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

法匹拉韦治疗洛匹那韦/利托那韦应答不佳的新型冠状病毒肺炎(COVID-19)患者的有效性与安全性的临床研究 

Scientific title:

Clinical study for safety and efficacy of Favipiravir in the treatment of novel coronavirus pneumonia (COVID-19) with poorly responsive ritonavir/ritonavir 

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:

蔡庆贤 

研究负责人:

刘映霞 

Applicant:

Cai Qingxian 

Study leader:

Liu Yingxia 

申请注册联系人电话:

Applicant telephone:

+86 18127814825 

研究负责人电话:

Study leader's telephone:

+86 755 61238922 

申请注册联系人传真 :

Applicant Fax:

+86 755 612223333-3100 

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:

cqx200000@163.com 

研究负责人电子邮件:

Study leader's E-mail:

yingxialiu@hotmail.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:

深圳市龙岗区布澜路29号 

研究负责人通讯地址:

深圳市龙岗区布澜路29号 

Applicant address:

29 Bulan Road, Logngang District, Shenzhen, Guangdong, China 

Study leader's address:

29 Bulan Road, Logngang District, Shenzhen, 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:

深圳市第三人民医院 

Applicant's institution:

Shenzhen the 3rd People's 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:

2020-002 

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:

深圳市第三人民医院科研伦理委员会 

Name of the ethic committee:

Shenzhen the 3rd People's Hospital Research Ethics 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:

王老师 

Contact Name of the ethic committee:

Mr. Wang 

伦理委员会联系地址:

深圳市龙岗区布澜路29号 

Contact Address of the ethic committee:

29 Bulan Road, Logngang District, Shenzhen, Guangdong, China 

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:

深圳市第三人民医院 

Primary sponsor:

The Third People's Hospital of Shenzhen  

研究实施负责(组长)单位地址:

广东省深圳市龙岗区布澜路29号 

Primary sponsor's address:

29 Bulan Road, Longgang District, Shenzhen, Guangdong, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

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:

探索性研究/预试验 

Study phase:

研究目的:

研究法匹拉韦治疗对洛匹那韦/利托那韦应答不佳的新型冠状病毒肺炎患者的有效性与安全性。 

Objectives of Study:

Study the safety and efficacy of Favipiravir in the treatment of novel coronavirus pneumonia (COVID-19) with poorly responsive ritonavir/ritonavir 

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:

1.年龄≥16岁且≤75岁,性别不限; 2.新型冠状病毒肺炎确诊患者; 3.在洛匹那韦/利托那韦规范治疗10天后,呼吸道或肛拭子标本检测新型冠状病毒核酸仍然呈阳性; 4.愿意在研究期间和治疗结束后7天内采取避孕措施。 5.吞服口服药无困难。 6.签署知情同意书。 

Inclusion criteria

1. 16 to 75 years of age, male or female; 2. Respiratory or blood samples tested positive for novel coronavirus; 3. A novel coronavirus nucleic acid was detected in respiratory or anal swabs after 10 days of standard treatment with roranavir / ritonavir; 4. Willing to take contraception during the study and within 7 days after treatment; 5. No difficulty in swallowing the Pills; 6. Willing to sign informed consent form.  

排除标准:

1.任何不能让方案安全进行的情况; 2.患者拒绝接受有创气管支持治疗(如需要); 3.妊娠或哺乳期女性:育龄女性妊娠试验阳性,哺乳期,流产或产后2周内。 4.任何导致需要接受肾脏替代治疗的疾病 5.既往对法匹拉韦存在过敏反应史 6.经研究者判定,受试者入组后无法依从研究干预、随访和自我评价。 

Exclusion criteria:

1. Any situation which the protocol cannot be carried out safely; 2. Patient refuses to receive invasive tracheal support (if needed); 3. Pregnant or lactating women:childbearing age women with positive pregnancy test, breastfeeding, miscarriage or within 2 weeks after delivery.Postmenopausal and hysterectomy women do not need a pregnancy test; 4. Patients with chronic liver and kidney disease and reaching end-stage; 5. Previous history of allergic reactions to Fapiravir or Lopinavir and Ritonavir; 6. After the investigator's judgment, the subjects could not participate the study protocol, follow-up or self-evaluation after enrollment.  

研究实施时间:

Study execute time:

From2020-02-22To 2020-05-31 

征募观察对象时间:

Recruiting time:

From2020-02-22To 2020-03-31 

干预措施:

Interventions:

组别:

对照组

样本量:

15

Group:

Control group

Sample size:

干预措施:

维持洛匹那韦/利托那韦方案不变

干预措施代码:

Intervention:

Keep ritonavir/ritonavir treatment

Intervention code:

组别:

试验组

样本量:

15

Group:

Experimental group

Sample size:

干预措施:

法匹拉韦

干预措施代码:

Intervention:

Favipiravir

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

血常规五分类,肝功能常规,肾功能四项,血气分析、胸片/胸部CT

指标类型:

主要指标 

Outcome:

Blood routine tests, Liver function examination, Renal function examination, Blood gas analysis, Chest CT examination

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:

鼻拭子

组织:

Sample Name:

Nasal swab

Tissue:

Destruction after use

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:

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 16 years
最大 Max age 75 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):

本研究采用分层随机,分层因素为患者病情轻重,将轻症与普通型患者归为一层,重症及危重症患者归入另一层。由杨明辉通过excel公式RAND()产生随机数字,利用RANK.AVG()公式对随机数字进行排序,再使用(MOD(E3,2)+1)公式求余数。余数1分入A组,余数2分入B组。

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

In this study, patients with mild and common diseases were classified into one layer, while patients with severe and critical diseases were classified into another layer. The random numbers are generated by Yang Minghui through the excel formula “rand ()”, sorted by the formula “rank. AVG ()”, and then

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

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):

通过Email向研究人员索取(41180423@qq.com)

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

Email the researchers (41180423@qq.com)

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:

项目进展中以及项目结题后,所有数据由我院随访中心统一收集、组织、存储,数据共享和复用有我院科研委员会和伦理委员会共同管理。

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

During the progress of the project and after the completion of the project, all data are collected, organized and stored by the follow-up center of our hospital. Data sharing and reuse are jointly managed by the research committee and the ethics committee of our hospital.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-23
return list