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陈倩医师:该研究的伦理审批文件未上传,请尽快上传并填写伦理委员会联系人。 金叶败毒颗粒治疗新型冠状病毒肺炎(COVID-19)有效性和安全性的随机、开放、平行对照临床试验
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注册号:

Registration number:

ChiCTR2000029755 

最近更新日期:

Date of Last Refreshed on:

2020-03-02 

注册时间:

Date of Registration:

2020-02-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

陈倩医师:该研究的伦理审批文件未上传,请尽快上传并填写伦理委员会联系人。 金叶败毒颗粒治疗新型冠状病毒肺炎(COVID-19)有效性和安全性的随机、开放、平行对照临床试验 

Public title:

A randomized, open, parallel-controlled clinical trial on the efficacy and safety of Jingyebaidu granules in treating novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

金叶败毒颗粒治疗新型冠状病毒肺炎(COVID-19)有效性和安全性的随机、开放、平行对照临床试验 

Scientific title:

A randomized, open, parallel-controlled clinical trial on the efficacy and safety of Jingyebaidu granules in treating 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:

ChiMCTR2000002999 

申请注册联系人:

陈倩 

研究负责人:

刘东 

Applicant:

Chen Qian 

Study leader:

Liu Dong 

申请注册联系人电话:

Applicant telephone:

+86 13477019908 

研究负责人电话:

Study leader's telephone:

+86 13507183749 

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:

4818425@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

ld_2069@163.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:

武汉市解放大道1095号 

研究负责人通讯地址:

武汉市解放大道1095号 

Applicant address:

1095 Jiefang Avenue, Wuhan, Hubei 

Study leader's address:

1095 Jiefang Avenue, Wuhan, Hubei 

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:

华中科技大学同济医学院附属同济医院 

Applicant's institution:

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

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-C20200124 

伦理委员会批件附件:

Approved file of Ethical Committee:

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:

Institutional Review Board, 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:

2020-02-11 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

武汉市解放大道1095号 

Contact Address of the ethic committee:

1095 Jiefang Avenue, Wuhan, Hubei 

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 of HUST 

研究实施负责(组长)单位地址:

武汉市解放大道1095号 

Primary sponsor's address:

1095 Jiefang Avenue, Wuhan, Hubei 

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):

同济医院

具体地址:

解放大道1095号

Institution
hospital:

Tongji Hospital

Address:

1095 Jiefang Avenue

经费或物资来源:

同济医院 

Source(s) of funding:

Tongji Hospital 

研究疾病:

新型病毒性肺炎(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:

本研究拟采用随机、开放、平行对照的试验设计,通过比较常规治疗与常规治疗加用金叶败毒颗粒组对2019-nCoV病毒性肺炎的疗效和安全性,来探寻新型冠状病毒有效的治疗方案,明确金叶败毒颗粒的治疗作用,为合理应用中药制剂提供可靠依据。 

Objectives of Study:

This study intends to use randomized, open, parallel-group trial design, to compare the curative effect and safety of routine treatment and routine treatment combined with Jinyebaidu disease in 2019 - nCoV viral pneumonia, to explore a effective treatment of the new coronavirus, to clarify the therapeutic effect of Jinyebaidu and to provide reliable basis of rational application of traditional Chinese medicine. 

药物成份或治疗方案详述:

给药方案: 试验组:常规治疗+金叶败毒颗粒组(口服,一次1-2袋,一日3次); 对照组:常规治疗,按第五版或更新版本诊疗方案中规定治疗,不使用中药。 试验制剂: 金叶败毒颗粒,生产厂家:华中科技大学同济医学院附属同济医院,鄂药制字Z20180245,储存条件:密封、常温储存。 

Description for medicine or protocol of treatment in detail:

Administration plan: Experimental group: routine treatment + Jinyebaidu granule( po, 1-2 bags once, 3 times a day); Control group: routinel treatment, treatment according to the fifth version of the diagnosis and treatment protocol, no use of traditional Chinese medicine. investigational preparation: Jinyebaidu granules, manufacturer: Tongji hospital affiliated to Tongji medical college of HUST, Z20180245, storage conditions: sealed, room temperature. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 根据《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》,符合2019-nCoV病毒肺炎的确诊患者:包括临床症状、肺部CT表现和核酸检测阳性; 2. 年龄在18周岁以上(包括18周岁)的住院患者,性别不限; 3. 愿意参加本项临床试验,签署知情同意书者。 

Inclusion criteria

1. Patients who were confirmed diagnosis of 2019-ncov virus pneumonia, according to the "pneumonia diagnosis and treatment program for novel coronavirus infection (trial version 5)",including clinical symptoms, pulmonary CT manifestations and positive nucleic acid test; 2. Inpatients 18 years old (including 18), regardless of gender; 3. Willing to participate in this clinical trial and sign the informed consent. 

排除标准:

1. 重症肺炎需要机械通气、危重型新型冠状病毒感染肺炎患者; 2. 预计48小时内死亡者; 3. 原发性免疫缺陷病、获得性免疫缺陷综合征、先天性呼吸道畸形、先天性心脏病、胃食管反流症、肺发育异常等基础疾病引起的呼吸道感染,有明确细菌感染证据; 4. 有以下状况的受试者:需每日治疗的哮喘,任何其他慢性呼吸道疾病,呼吸系统细菌感染如化脓性扁桃体炎,急性气管支气管炎,鼻窦炎,中耳炎等其他影响临床试验评估的呼吸道疾病。胸部CT证实存在严重的肺间质病变、支气管扩张等基础性肺部疾病患者; 5. 经研究者判断,既往或现在患有的疾病,可能影响患者参加试验或影响研究的转归,包括:恶性病、自身免疫性疾病、严重营养不良、肝肾疾患、血液病、神经系统疾病、和内分泌疾病;现患有严重影响免疫系统的疾病,如:人类免疫缺陷病毒(HIV)感染,或血液系统,或脾切除、器官移植术等; 6. 精神状态不能合作者,患有精神性疾病、不能自制、不能明确表达者; 7. 过敏体质(如对两种或以上药物、食物过敏者)或对本品及常规治疗药物等有过敏史者; 8. 有药物滥用或依赖史; 9. 妊娠或哺乳期妇女; 10. 其他研究者认为不适宜参加临床试验者。 

Exclusion criteria:

1. Patients with severe pneumonia requiring mechanical ventilation and severe new coronavirus infection with pneumonia; 2. Death is expected within 48 hours; 3. There is clear evidence of bacterial infection in respiratory tract infections caused by primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory tract malformation, congenital heart disease, gastroesophageal reflux disease, pulmonary dysplasia and other basic diseases; 4 subjects with the following conditions: daily treatment of asthma, any other chronic respiratory diseases, respiratory bacterial infections such as suppurative tonsillitis, acute tracheal bronchitis, sinusitis, otitis media and other respiratory diseases that affect clinical trial evaluation.Chest CT confirmed the existence of severe pulmonary interstitial lesions, bronchiectasis and other basic pulmonary diseases; 5. According to the researcher's judgment, the previous or current diseases may affect the patient's participation in the trial or the outcome of the study, including malignant diseases, autoimmune diseases, severe malnutrition, liver and kidney diseases, blood diseases, nervous system diseases, and endocrine diseases;He is suffering from serious diseases that affect the immune system, such as human immunodeficiency virus (HIV) infection, or blood system, or splenectomy, organ transplantation, etc. Unable to cooperate in mental state, suffering from mental disease, unable to control, unable to express clearly; Allergic constitution (such as allergic to two or more drugs or food) or history of allergy to this product and conventional treatment drugs; 8. A history of substance abuse or dependence; 9. Pregnant or nursing women; 10. Other researchers consider it inappropriate to participate in clinical trials. 

研究实施时间:

Study execute time:

From2020-02-12To 2020-05-30 

征募观察对象时间:

Recruiting time:

From2020-02-15To 2020-04-30 

干预措施:

Interventions:

组别:

试验组

样本量:

60

Group:

experimental group

Sample size:

干预措施:

常规治疗+金叶败毒颗粒组,口服,一次1-2袋,一日3次

干预措施代码:

Intervention:

routine treatment, Jinyebaidu granule, po, 1-2 bags once, 3 times a day;

Intervention code:

组别:

对照组

样本量:

60

Group:

control group

Sample size:

干预措施:

常规治疗,按第五版或更新版本诊疗方案中规定治疗,不使用中药

干预措施代码:

Intervention:

routinel treatment, treatment according to the fifth version of the diagnosis and treatment protocol, no use of traditional Chinese medicine.

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):

同济医院 

单位级别:

武汉市解放大道1095 

Institution
hospital:

Tongji Hospital  

Level of the institution:

1095 Jiefang Avenue 

测量指标:

Outcomes:

指标中文名:

有效性观察指标

指标类型:

主要指标 

Outcome:

Validity observation index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性观测指标

指标类型:

次要指标 

Outcome:

Safety observation index

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 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):

本研究采用随机、开放、平行设计。在研究中每名受试者进入对照组或试验组将由随机表确定。随机表应用SAS(9.3或以上版本)随机产生,组间比例为1:1。

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

This study use randomized, open and parallel design. Whether the subject will enter into the control group or test group in the study will be determined by a randomized table.The randomized table was generated by SAS (version 9.3 or above) with an intergroup ratio of 1:1.

盲法:

open label

Blinding:

open label

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):

以总结报告和论文形式公开

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

Be made public in the form of final reports and papers

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:

数据使用CRF的方式收集,疫情期间,所有数据收集均采用电子化

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

The data was collected by CRF, and all data were collected electronically during the epidemic

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-02-12
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