今天是:2020-06-06 星期六

一项为期十天、随机、平行组研究,在新型冠状病毒肺炎(COVID-19)患者中评估常规治疗基础上加用注射用七叶皂苷钠与常规治疗相比的疗效和安全性
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注册号:

Registration number:

ChiCTR2000029742 

最近更新日期:

Date of Last Refreshed on:

2020-02-17 

注册时间:

Date of Registration:

2020-02-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项为期十天、随机、平行组研究,在新型冠状病毒肺炎(COVID-19)患者中评估常规治疗基础上加用注射用七叶皂苷钠与常规治疗相比的疗效和安全性 

Public title:

A randomized, parallel controlled trial for the efficacy and safety of Sodium Aescinate Injection in the treatment of patients with pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一项为期十天、随机、平行组研究,在新型冠状病毒肺炎(COVID-19)患者中评估常规治疗基础上加用注射用七叶皂苷钠与常规治疗相比的疗效和安全性 

Scientific title:

A randomized, parallel controlled trial for the efficacy and safety of Sodium Aescinate Injection in the treatment of patients with 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:

杨阳 

研究负责人:

宁琴、韩梅芳 

Applicant:

Yang Yang 

Study leader:

Qin Ning, Meifang Han 

申请注册联系人电话:

Applicant telephone:

+86 21 53894282 

研究负责人电话:

Study leader's telephone:

+86 27 83662688 

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:

yangyanger@luye.cn 

研究负责人电子邮件:

Study leader's E-mail:

31531955@qq.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:

上海市闵行区田林路1036号科技绿洲三期12号楼 

研究负责人通讯地址:

武汉市硚口区解放大道1095号 

Applicant address:

1036 Tianlin Road, Minhang District, Shanghai, China 

Study leader's address:

1095 Jiefang Avenue, Qiaokou 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:

山东绿叶制药有限公司 

Applicant's institution:

Shandong Luye Pharmaceutical 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:

TJ-C20200116 

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同济医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-07 

伦理委员会联系人:

宁琴、韩梅芳 

Contact Name of the ethic committee:

Qin Ning, Meifang Han 

伦理委员会联系地址:

武汉市硚口区解放大道1095号 

Contact Address of the ethic committee:

1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, 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:

华中科技大学同济医学院附属同济医院 

Primary sponsor:

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

研究实施负责(组长)单位地址:

武汉市硚口区解放大道1095号 

Primary sponsor's address:

1095 Jiefang Avenue, Qiaokou 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

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

华中科技大学同济医学院附属同济医院

具体地址:

硚口区解放大道1095号

Institution
hospital:

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

Address:

1095 Jiefang Avenue, Qiaokou District

经费或物资来源:

华中科技大学同济医学院附属同济医院,山东绿叶制药有限公司 

Source(s) of funding:

Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology, Shandong Luye Pharmaceutical 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:

上市后药物 

Study phase:

研究目的:

本研究的目的是在新型冠状病毒肺炎患者中评估常规治疗基础上加用注射用七叶皂苷钠(麦通纳)与常规治疗相比的疗效和安全性;其次,比较常规治疗加用注射用七叶皂苷钠与常规治疗加用糖皮质激素的疗效差异。 

Objectives of Study:

The aim of this study is to evaluate the efficacy and safety of Sodium Aescinate for Injection compared with conventional treatment in patients with novel coronavirus pneumonia (2019-nCoV). Secondly, to compare the efficacy of conventional therapy plus Sodium Aescinate for Injection and conventional therapy plus glucocorticoids. 

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≥18周岁,且≤70周岁,性别不限; (2)病毒核酸检测诊断为新型冠状病毒肺炎患者,或虽病毒核酸检测阴性,或暂未进行病毒核酸检测,但经研究者判断为新型冠状病毒肺炎患者; (3)理解、同意参加本研究并签署知情同意书。 (4)根据《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》临床分型指导原则,普通型患者入选标准:具有发热、呼吸道等症状,影像学可见肺炎表现;重型患者入选标准:符合下列任何一条:1)呼吸窘迫,RR≥30次/分;2)静息状态下,指氧饱和度≤93%;3)动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg(1mmHg=0.133kPa)。 

Inclusion criteria

1. Aged >=18 to 70 years; 2. Diagnosed 2019-nCoV infected patients by viral nucleic acid,or although the test was negative and even not be detected, the reseachers judged it to be a novel coronavirus pneumonia; 3. Understand and agree to participate in this study and sign informed consent; 4. According to the guideline of clinical classification of novel coronavirus pneumonia (2019-nCoV) diagnosis and treatment plan (trial version fifth), the general patients were included in the selection criteria: fever, respiratory tract symptoms, imaging findings of pneumonia; Severe patients were selected according to the following criteria: 1) respiratory distress, RR >= 30 times / minute; 2) resting state, mean oxygen saturation less than 93%; 3) artery. PaO2 / FiO2 <= 300MMHG (1mmhg = 0.133kpa). 

排除标准:

(1)孕妇或哺乳期妇女,或正在备孕者; (2)对本方案药品成分过敏者。 (3)严重心血管疾病,如严重心功能不全、二度或三度房室传导阻滞等; (4)严重肝功能不全:定义为ALT>2倍正常值上限或AST>2倍正常值上限; (5)严重肾功能不全:定义为肌酐>1.5倍正常值上限; (6)有哮喘、COPD严重呼吸系统疾病的; (7)严重血液疾病,如凝血障碍、系统性出血、血小板疾病等; (8)严重内分泌系统疾病,如II型糖尿病等; (9)恶性肿瘤患者; (10)长期服用抗水肿药物的患者; (11)有重大手术史; (12)参加其它临床研究者。 

Exclusion criteria:

1. Pregnant or lactating women, or pregnant; 2. Those who are allergic to the drug ingredients of this program; 3. Severe cardiovascular diseases, such as severe center of gravity dysfunction, second or third degree atrioventricular block, etc.; 4. Severe hepatic insufficiency: defined as the upper limit of ALT > 2 times normal value or AST > 2 times normal value; 5. Severe renal insufficiency: defined as creatinine > 1.5 times the upper limit of normal value; 6. Have asthma, COPD serious respiratory disease; 7. Serious blood diseases, such as coagulation disorders, systemic bleeding, platelet diseases, etc; 8. Serious endocrine system diseases, such as type II diabetes; 9. Patients with malignant tumor; 10. Patients taking antiedematous drugs for a long time; 11. Major operation history; 12. Other clinical researchers. 

研究实施时间:

Study execute time:

From2020-02-10To 2020-12-31 

干预措施:

Interventions:

组别:

普通患者常规治疗组

样本量:

30

Group:

General patients treated with normal treatment

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Normal Treatment

Intervention code:

组别:

普通患者试验组

样本量:

30

Group:

General patients experimental group

Sample size:

干预措施:

常规治疗联合注射用七叶皂苷钠

干预措施代码:

Intervention:

Normal Treatment plus Sodium Aescinate for Injection

Intervention code:

组别:

重症患者对照组1

样本量:

10

Group:

Severe patients control group 1

Sample size:

干预措施:

常规治疗联合激素治疗

干预措施代码:

Intervention:

Normal treatment plus hormonotherapy

Intervention code:

组别:

重症患者对照组2

样本量:

10

Group:

Severe patients control group 2

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Normal Treatment

Intervention code:

组别:

重症患者试验组

样本量:

10

Group:

Severe patients experimental group

Sample size:

干预措施:

常规治疗联合注射用七叶皂苷钠

干预措施代码:

Intervention:

Normal Treatment plus Sodium Aescinate for Injection

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学同济医学院附属同济医院 

单位级别:

三级甲等 

Institution
hospital:

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

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

肺部影像学(CT)

指标类型:

主要指标 

Outcome:

Chest imaging (CT)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性

指标类型:

次要指标 

Outcome:

Safty

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血生化

指标类型:

次要指标 

Outcome:

Blood biochemistry index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病毒核酸检测诊断

指标类型:

次要指标 

Outcome:

viral nucleic acid fo 2019-nCoV

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:

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 70 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):

随机软件:SAS;随机方法:分层区组随机,以新型冠状病毒肺炎严重程度(普通型、重型)为分层因素

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

Computer sorftware SAS to be used to generate the random number sequence, stratification by the characteristics of the disease.

盲法:

Not stated

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):

试验完成后12个月内公开,研究数据将在临床试验公共管理平台ResMan上公布http://www.medresman.org.cn.

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

The data will be published in the public management platform of clinical trials ResMan after the Study Completed 12months, http://www.medresman.org.cn.

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:

1、设计临床专用CRF表,专人进行纸质记录,并录入数据库,保存于研究者处;患者临床病史记录为纸质版,主管医师签字后保存于同济医院病案室,以备查询;2、采用EDC数据采集及管理系统:https://ecrf.mdlinklab.com

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

Each patient are required to fill one CRF table, all th CRF tables saved byresearchers and will be saved by data base. The medical records with the signature of the doctor in charge are all in print edition, which will be saved in the medical-record department of Wuhan Tongji Hospical;2、EDC will be used to capture and manage the data.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-11
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