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Clinical study for safety and efficacy of Favipiravir in the treatment of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000029600 

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:

法匹拉韦治疗新型冠状病毒肺炎(COVID-19)患者的安全性和有效性的临床研究 

Public title:

Clinical study for safety and efficacy of Favipiravir 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:

法匹拉韦治疗新型冠状病毒肺炎(COVID-19)患者的安全性和有效性的临床研究 

Scientific title:

Clinical study on safety and efficacy of Favipiravir 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:

廖雪姣 

研究负责人:

刘映霞 

Applicant:

Liao Xuejiao 

Study leader:

Liu Yingxia 

申请注册联系人电话:

Applicant telephone:

+86 755 612223333-1214 

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:

 

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:

392402597@qq.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:

广东省深圳市龙岗区布澜路29号 

研究负责人通讯地址:

广东省深圳市龙岗区布澜路29号 

Applicant address:

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

Study leader's address:

29 Bulan Road, Longgang 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:

The Third People's Hospital of Shenzhen 

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:

深圳三院伦审科研字(2020-002-02)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:

深圳市第三人民医院科研伦理委员会 

Name of the ethic committee:

Ethics Committees of The Third People's Hospital of Shenzhen (Branch of Scientific Research) 

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:

黄芳 

Contact Name of the ethic committee:

Huang Fang 

伦理委员会联系地址:

广东省深圳市龙岗区布澜路29号 

Contact Address of the ethic committee:

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

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 755 61222333-6665 

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:

国家:

中国

省(直辖市):

广东

市(区县):

深圳

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

深圳市第三人民医院

具体地址:

广东省深圳市龙岗区布澜路29号

Institution
hospital:

The Third People's Hospital of Shenzhen

Address:

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

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:

观察法匹拉韦治疗新型冠状肺炎的安全性和疗效. 

Objectives of Study:

Observe the safety and efficacy of Favipiravir in the treatment of 2019-nCoV 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:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

(1)年龄≥16岁且≤75岁,性别不限; (2)呼吸道标本或血液标本检测新型冠状病毒核酸呈阳性; (3)发病7天以内:发病的定义为出现体温升高超过38℃(腋温)或至少一项新型冠状病毒肺炎相关全身或呼吸道症状; (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. Within 7 days of onset: Onset is defined as body temperature exceeding 38 degree C (armpit temperature) or at least one 2019-nCoV pneumonia related systemic or respiratory symptom; 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。绝经后及子宫切除的女性无需进行妊娠试验; (4)患有慢性肝、肾疾病并达到终末期的患者; (5)既往对法匹拉韦或者洛匹那韦利托那韦存在过敏反应史; (6)目前或过去28天内参加过另一项抗新型冠状病毒治疗的试验; (7)经研究者判定,受试者入组后无法已从研究干预、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. Currently or in the past 28 days, participated in another clinical trial against novel coronavirus treatment; 7. 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:

From2020-01-30To 2020-04-29 

干预措施:

Interventions:

组别:

A组

样本量:

30

Group:

Group A

Sample size:

干预措施:

α干扰素雾化

干预措施代码:

Intervention:

alpha-Interferon atomization

Intervention code:

组别:

B组

样本量:

30

Group:

Group B

Sample size:

干预措施:

洛匹那韦利托那韦+α干扰素雾化

干预措施代码:

Intervention:

Lopinavir and Ritonavir + alpha-Interferon atomization

Intervention code:

组别:

C组

样本量:

30

Group:

Group C

Sample size:

干预措施:

法匹拉韦+α干扰素雾化

干预措施代码:

Intervention:

Favipiravir + alpha-Interferon atomization

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):

深圳 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

深圳市第三人民医院 

单位级别:

三级甲等 

Institution
hospital:

The Third People's Hospital of Shenzhen  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

新型冠状病毒PCR检测下降的速度

指标类型:

主要指标 

Outcome:

Declining speed of Novel Coronavirus by PCR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新型冠状病毒PCR检测转阴的时间

指标类型:

主要指标 

Outcome:

Negative Time of Novel Coronavirus by PCR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胸部影像学改善率

指标类型:

主要指标 

Outcome:

Incidentce rate of chest imaging

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝酶异常发生率

指标类型:

主要指标 

Outcome:

Incidence rate of liver enzymes

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾损害发生率

指标类型:

主要指标 

Outcome:

Incidence rate of kidney damage

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:

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:

标本中文名:

外周血

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:

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):

不适用

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

Not applicable

盲法:

N/A

Blinding:

N/A

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):

研究数据备案平台

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

Research Data Deposit

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:

将由接受过GCP和院感防护培训的研究医生采集所有方案要求的临床数据,然后将数据录入CRF中。在数据录入与核查结束后,由数据管理人员和研究者共同对数据进行审核和分析。

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

All clinical data will be collected by research doctors of trained GCP and hospital infection protection. The data is then entered into the CRF. After the completion of data entry and verification, data management personnel, researchers, shall jointly review and analysis the data.

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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