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雾化吸入注射用重组病毒巨噬细胞炎性蛋白(vMIP)治疗新型冠状病毒肺炎(COVID-19)有效性和安全性的单臂临床试验
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注册号:

Registration number:

ChiCTR2000029636 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

雾化吸入注射用重组病毒巨噬细胞炎性蛋白(vMIP)治疗新型冠状病毒肺炎(COVID-19)有效性和安全性的单臂临床试验 

Public title:

Efficacy and safety of aerosol inhalation of vMIP in the treatment of novel coronavirus pneumonia (COVID-19): a single arm clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

雾化吸入注射用重组病毒巨噬细胞炎性蛋白(vMIP)治疗新型冠状病毒肺炎(COVID-19)有效性和安全性的单臂临床试验 

Scientific title:

Efficacy and safety of aerosol inhalation of vMIP in the treatment of novel coronavirus pneumonia (COVID-19): a single arm clinical trial 

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:

邝发豪/孙晗笑 

研究负责人:

胡波/李伟 

Applicant:

Kuang fa-hao, Sun han-xiao 

Study leader:

Hu bo, Li wei 

申请注册联系人电话:

Applicant telephone:

+86 13532102011 

研究负责人电话:

Study leader's telephone:

+86 13707114863 

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:

kuang020@msn.com 

研究负责人电子邮件:

Study leader's E-mail:

hubo@mail.hust.edu.cn 

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:

广州市黄埔区高新技术开发区瑞泰路2号B栋2楼101号 

研究负责人通讯地址:

湖北省武汉市解放大道1277号 

Applicant address:

Room 101, Second Floor, Building B, 2 Ruitai Road, High-Tech Development Zone, Huangpu District, Guangzhou 

Study leader's address:

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei, 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:

广州溯原生物科技股份有限公司 

Applicant's institution:

Guangzhou Suyuan Biotechnology Co., Ltd 

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)伦审字(0006)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:

华中科技大学同济医学院附属协和医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-06 

伦理委员会联系人:

徐戎 

Contact Name of the ethic committee:

Xu Rong 

伦理委员会联系地址:

湖北省武汉市解放大道1277号 

Contact Address of the ethic committee:

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 027-83691785 

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:

华中科技大学同济医学院附属协和医院 

Primary sponsor:

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

研究实施负责(组长)单位地址:

湖北省武汉市解放大道1277号 

Primary sponsor's address:

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei, 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):

湖北省

市(区县):

武汉市

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

华中科技大学同济医学院附属协和医院

具体地址:

解放大道1277号

Institution
hospital:

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

Address:

1277 Jiefang Avenue, Jianghan District

经费或物资来源:

广州溯原生物科技股份有限公司赞助 

Source(s) of funding:

Sponsored by Guangzhou Suyuan Biotechnology Co., Ltd 

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:

在临床常规治疗的基础上,评价雾化吸入vMIP对新型冠状病毒感染肺炎患者的有效性和安全性。 

Objectives of Study:

On the basis of clinical routine treatment, to evaluate the efficacy and safety of aerosol inhalation of vMIP in patients with new coronavirus infection 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:

单臂 

Study design:

Single arm 

纳入标准:

1)年龄≥18周岁,性别不限,住院患者; 2)确诊为新型冠状病毒感染患者:呼吸道标本或血液标本实时荧光RT-PCR检测2019-nCoV核酸阳性,或者,呼吸道标本或血液标本病毒基因测序,与已知的2019-nCoV高度同源; 3)根据“新型冠状病毒感染的肺炎诊疗方案(试行第五版)”标准,临床分型为普通型或重型; 4)症状发作与入组之间的时间间隔在7天以内,症状发作主要以发热作为判断依据,若无发热可使用咳嗽或其他相关症状如乏力、鼻塞、流涕、胸闷、咽喉痛、肌肉酸疼、腹泻等; 5)已签署知情同意书。 

Inclusion criteria

1) Aged >=18 years, gender unlimited, inpatient; 2) Patients with new coronavirus infection were confirmed: respiratory or blood samples were positive for 2019 ncov nucleic acid by real-time fluorescent RT-PCR, or respiratory or blood samples were highly homologous with known 2019 ncov gene sequencing; 3) According to the standard of "diagnosis and treatment plan for pneumonia with new coronavirus infection (trial version 5)", the clinical types are common type or severe type; 4) The time interval between symptom onset and enrollment was within 7 days. The symptom onset was mainly based on fever. If there was no fever, coughing or other related symptoms could be used, such as fatigue, nasal obstruction, runny nose, chest distress, sore throat, muscle ache, diarrhea, etc; 5) Informed consent has been signed. 

排除标准:

1)已知或怀疑对vMIP的组成成分过敏。 2)已确诊的乙肝、丙肝、艾滋病等病毒感染者。 3)合并有急性呼吸窘迫综合征(ARDS)。 4)根据研究者的判断,具有不适合参加本试验的其它情况。 5)妊娠期、哺乳期妇女或在试验期间及结束6个月内有生育计划。 6)给药前12周内参加过其它临床试验或者正在使用试验性药物。 

Exclusion criteria:

1) Known or suspected to be allergic to the components of vMIP. 2) Confirmed hepatitis B, C, AIDS and other viral infections. 3) Acute respiratory distress syndrome (ARDS) was found. 4) According to the judgment of the researchers, there are other conditions that are not suitable for the experiment. 5) Pregnant, lactating women or during the trial period and within 6 months after the end of the family planning. 6) Have participated in other clinical trials or are using experimental drugs within 12 weeks before administration. 

研究实施时间:

Study execute time:

From2020-02-07To 2020-07-30 

干预措施:

Interventions:

组别:

试验组

样本量:

40

Group:

Case series

Sample size:

干预措施:

标准治疗+vMIP雾化吸入

干预措施代码:

Intervention:

Conventional standardized treatment and vMIP atomized inhalation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北省 

市(区县):

武汉市 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学同济医学院附属协和医院 

单位级别:

三级甲等 

Institution
hospital:

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

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

2019-nCoV核酸转阴时间(呼吸道分泌物),或解除隔离时间

指标类型:

主要指标 

Outcome:

2019-nCoV nucleic acid turning negative time (from respiratory secretion), or the time to release isolation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发热、咳嗽、乏力等症状改善

指标类型:

次要指标 

Outcome:

Clearance rate and time of main symptoms (fever, fatigue, cough)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫指标

指标类型:

次要指标 

Outcome:

immune indices

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:

血液

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:

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 18 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):

非随机

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

Non-random

盲法:

N/A

Blinding:

N/A

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):

以论文的形式提交;通过中国知网查询

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

IPD will be public accessable via CNKI; Submit in the form of paper

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:

病例报告表、电子采集和管理系统

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

CRF、EDC

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-02-08
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