Today is 2020-10-31

Favipiravir Combined With Tocilizumab in the Treatment of novel coronavirus pneumonia (COVID-19) - A Multicenter, Randomized, Controlled Trial
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注册号:

Registration number:

ChiCTR2000030894 

最近更新日期:

Date of Last Refreshed on:

2020-03-16 

注册时间:

Date of Registration:

2020-03-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

法匹拉韦片联合托珠单抗治疗新型冠状病毒肺炎(COVID-19)的多中心、随机、对照临床试验研究 

Public title:

Favipiravir Combined With Tocilizumab in the Treatment of novel coronavirus pneumonia (COVID-19) - A Multicenter, Randomized, Controlled Trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

法匹拉韦片联合托珠单抗治疗新型冠状病毒肺炎(COVID-19)的多中心、随机、对照临床试验研究 

Scientific title:

Favipiravir Combined With Tocilizumab in the Treatment of novel coronavirus pneumonia (COVID-19) - A Multicenter, Randomized, Controlled Trial 

研究课题代号(代码):

Study subject ID:

2020YFC0844100 

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:

赵鸿 

研究负责人:

王贵强 

Applicant:

Hong Zhao 

Study leader:

Guiqiang Wang 

申请注册联系人电话:

Applicant telephone:

+86 13810765943 

研究负责人电话:

Study leader's telephone:

+86 13911405123 

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:

zhaohong_pufh@bjmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

john131212@126.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:

北京市西城区西什库大街8号 

研究负责人通讯地址:

北京市西城区西什库大街8号 

Applicant address:

8 Xishiku Street, Xicheng District, Beijing, China 

Study leader's address:

8 Xishiku Street, Xicheng 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:

北京大学第一医院 

Applicant's institution:

Peking University First 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科研056 

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:

北京大学第一医院生物医学研究伦理委员会 

Name of the ethic committee:

Biomedical research ethics committee of the Peking University First Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-03 

伦理委员会联系人:

郭晓蕙,王爱平,魏敏吉,于岩岩,朱赤红 

Contact Name of the ethic committee:

Xiaohui Guo, Aiping Wang, Minji Wei, Yanyan Yu, Chihong Zhu 

伦理委员会联系地址:

北京市西城区大红罗场街6号 

Contact Address of the ethic committee:

6 Da-Hong-Luo-Chang Street, Xicheng District, Beijing, 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:

北京大学第一医院 

Primary sponsor:

Peking University First Hospital 

研究实施负责(组长)单位地址:

北京市西城区西什库大街8号 

Primary sponsor's address:

8 Xishiku Street, Xicheng 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):

北京大学第一医院

具体地址:

北京市西城区西什库大街8号

Institution
hospital:

Peking University First Hospital

Address:

8 Xishiku Street, Xicheng District

经费或物资来源:

自筹 

Source(s) of funding:

self-financed 

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:

本研究目的是评价法匹拉韦片联合托珠单抗治疗新型冠状病毒肺炎的有效性和安全性。 

Objectives of Study:

The purpose of this study is to evaluate the efficacy and safety of favipiravir combined with tocilizumab in the treatment of corona virus disease 2019. 

药物成份或治疗方案详述:

法匹拉韦的用法:第1天,1次1600 mg,1日2次;从第2天到第7天,1次600 mg,1日2次,口服给药,最大服用天数不超过7天。 托珠单抗的用法:首次剂量 4~8 mg/ Kg,推荐剂量 400mg,加入生理盐水 100 ml ,输注时间大于 1 小时。对于发热患者,首剂应用后 24 小时内如仍有发热,追加应用一次(剂量同前), 两次用药间隙≥12 小时,累计给药次数最多为 2 次,单次最大剂量不超过 800mg。 

Description for medicine or protocol of treatment in detail:

Favipiravir: On the 1st day, 1600mg each time, twice a day; from the 2nd to the 7th day, 600mg each time, twice a day. Oral administration, the maximum number of days taken is not more than 7 days. Tocilizumab:The first dose is 4 ~ 8mg/kg and the recommended dose is 400mg. For fever patients, an additional application (the same dose as before) is given if there is still fever within 24 hours after the first dose and the interval between two medications ≥ 12 hours.Intravenous infusion, The maximum of cumulative number is two, and the maximum single dose does not exceed 800mg. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.男性及女性,18岁-65周岁 2.临床诊断为新型冠状病毒肺炎(普通型、重型) 3. IL-6 升高 4.本人或委托代理人签署知情同意书 5.可以口服用药或者接受口服用药的受试者; 6.同意收集临床样本; 7.本人或委托代理人签署知情同意书 8.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; 9.男性同意在最后一次口服药物7天内采取有效避孕措施。 

Inclusion criteria

1. Male and female aged 18-65 years; 2. Clinically diagnosed with Corona Virus Disease 2019; 3. Increased interleukin-6; 4. Sign the informed consent; 5. Subjects who can take medicine orally; 6. Agree to collect clinical samples; 7. Female subjects of childbearing age are not pregnant and agree to take effective contraception within 7 days of the last oral medication to ensure that they are not pregnant within 3-6 months; 8. Male patients agree to effective contraception within 7 days of 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; ● 试者在入院前一周内接受过洛匹那韦/利多那韦、利巴韦林、磷酸氯喹、羟氯喹、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; ● 对法匹拉韦或托珠单抗成分过敏 ● ALT/AST>5 倍 ULN; ● 中性粒细胞<0.5×109/L,血小板小于 50×109/L; ● 明确诊断有风湿免疫、恶性肿瘤等相关疾病; ● 长期口服抗排斥药物或者免疫调节药物; ● 活动性肝炎、结核,合并有明确的细菌感染和真菌感染患者; ● 器官移植患者; ● 精神障碍患者。 

Exclusion criteria:

1. Cases of severe vomiting that make it difficult to take the drug orally; 2. Allergic to Favipiravir or tocilizumab; 3. Pregnant and lactating women; 4. Subjects received specific antiviral drugs such as lopinavir / ritonavir, ribavirin, arbidol, chloroquine phosphate, hydroxychloroquine, and monoclonal antibodies within one week before admission; 5. Cases of respiratory failure and requiring mechanical ventilation; 6. Cases of shock; 7. Combined organ failure requires ICU monitoring and treatment; 8. Predicted clinically that there is no hope of survival, or cases of deep coma that do not respond to supportive treatment measures within three hours of admission; 9. Alanine aminotransferase / Aspartate aminotransferase> 5 times of upper limit of normal; 10. Neutrophils <0.5 × 10^9 / L, platelets less than 50 x 10^9/L; 11. Clear diagnosis of rheumatoid immunity, malignant tumors and other related diseases 12. Long-term oral anti-rejection drugs or immunomodulatory drugs; 13. Allergic reactions to tocilizumab or any excipients; 14. Patients with active hepatitis, tuberculosis, and definite bacterial and fungal infections; 15. Organ transplant patients; 16. Patients with mental disorders. 

研究实施时间:

Study execute time:

From2020-03-01To 2020-05-31 

征募观察对象时间:

Recruiting time:

From2020-03-01To  

干预措施:

Interventions:

组别:

1组

样本量:

90

Group:

Group 1

Sample size:

干预措施:

法匹拉韦片联合托珠单抗

干预措施代码:

Intervention:

Favipiravir Combined With Tocilizumab

Intervention code:

组别:

2组

样本量:

30

Group:

Group 2

Sample size:

干预措施:

法匹拉韦片

干预措施代码:

Intervention:

Favipiravir

Intervention code:

组别:

3组

样本量:

30

Group:

Group 3

Sample size:

干预措施:

托珠单抗

干预措施代码:

Intervention:

Tocilizumab

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):

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):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

华中科技大学同济医院 

单位级别:

三甲医院 

Institution
hospital:

Tongji Hospital of Huazhong University of Science and Technology  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

华中科技大学协和医院肿瘤医院 

单位级别:

三甲医院 

Institution
hospital:

Cancer Hospital Union Hospital Tongji Medical College Huazhong University of Science and Technology  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

华中科技大学协和医院西院 

单位级别:

三甲医院 

Institution
hospital:

West Hospital Union Hospital Huazhong University of Science and Technology  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉金银潭医院 

单位级别:

三甲医院 

Institution
hospital:

Jinyintan Hospital of Wuhan  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉火神山医院 

单位级别:

 

Institution
hospital:

Huoshenshan Hospital of Wuhan  

Level of the institution:

 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉肺科医院 

单位级别:

三甲医院 

Institution
hospital:

Wuhan Pulmonary Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉中南大学附属医院 

单位级别:

三甲医院 

Institution
hospital:

Zhongnan Hospital of Wuhan University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

安徽医科大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

Anhui Medical University Affiliated First Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

鄂州市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Ezhou Central Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

临床治愈率

指标类型:

主要指标 

Outcome:

Clinical cure rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病毒核酸检测阴转率和阳性转阴性的天数

指标类型:

次要指标 

Outcome:

Viral nucleic acid test negative conversion rate and days from positive to negative

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:

肺部影像学改善时间

指标类型:

次要指标 

Outcome:

Lung imaging improvement time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

以新冠肺炎为主要因素的病死率

指标类型:

次要指标 

Outcome:

Mortality rate because of Corona Virus Disease 2019

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

以新冠肺炎为主要因素的病死率

指标类型:

次要指标 

Outcome:

Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

平均住院时间

指标类型:

次要指标 

Outcome:

Mean in-hospital time

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:

concentration 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:

lymphocyte absolute value and its percentage

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:

鼻咽拭子或肛拭子

组织:

Sample Name:

nasopharyngeal swabs or anal swabs

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:

血标本

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 18 years
最大 Max age 65 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):

随机数字表

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 ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

20200531在线

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

May 31, 2020 Online

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

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:

 2020-03-16
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