今天是:2020-07-07 星期二

中药治疗新型冠状病毒感染肺炎(COVID-19)重型患者随机对照试验
下载XML文档

注册号:

Registration number:

ChiCTR2000029418 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-01-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中药治疗新型冠状病毒感染肺炎(COVID-19)重型患者随机对照试验 

Public title:

Chinese Herbal medicine for Severe nevel coronavirus pneumonia (COVID-19): a Randomized Controlled Trial 

注册题目简写:

 

English Acronym:

CHASE-2019-nCoV 

研究课题的正式科学名称:

中药治疗新型冠状病毒感染肺炎(COVID-19)重型患者随机对照试验 

Scientific title:

Chinese Herbal medicine for Severe nevel coronavirus pneumonia (COVID-19): a Randomized Controlled 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:

ChiMCTR2000002946 

申请注册联系人:

刘岩 

研究负责人:

梁腾霄,王彤,郝学增,张敬锋,张耀圣 

Applicant:

Yan Liu 

Study leader:

Tengxiao Liang, Tong Wang, Xuezeng Hao, Jingfeng Zhang, Yaosheng Zhang 

申请注册联系人电话:

Applicant telephone:

+86 010 84013190 

研究负责人电话:

Study leader's telephone:

+86 010 84012510 

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:

liuyantcm@163.com 

研究负责人电子邮件:

Study leader's E-mail:

shanghongcai@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:

北京市东城区海运仓胡同5号 

研究负责人通讯地址:

北京市东城区海运仓胡同5号 

Applicant address:

5 Haiyuncang Lane, Dongcheng District, Beijing 

Study leader's address:

5 Haiyuncang Lane, Dongcheng District, Beijing 

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:

北京中医药大学东直门医院 

Applicant's institution:

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine 

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:

DZMEC-KY-2020-09 

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:

北京中医药大学东直门医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-31 

伦理委员会联系人:

商建伟 

Contact Name of the ethic committee:

Jianwei Shang 

伦理委员会联系地址:

北京市东城区海运仓5号北京中医药大学东直门医院 

Contact Address of the ethic committee:

Dongzhimen Hospital, 5 Haiyuncang, Dongcheng District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010 84012709 

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:

北京中医药大学东直门医院 

Primary sponsor:

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine 

研究实施负责(组长)单位地址:

北京市东城区海运仓胡同5号 

Primary sponsor's address:

5 Haiyuncang Lane, Dongcheng District, Beijing 

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):

北京中医药大学东直门医院

具体地址:

东城区海运仓胡同5号

Institution
hospital:

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

Address:

5 Haiyuncang Lane, Dongcheng District

经费或物资来源:

北京中医药大学/北京中医药大学东直门医院(No.2020-dzmyy-lczx-yj001) 

Source(s) of funding:

Beijing University of Chinese Medicine, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine No.2020-dzmyy-lczx-yj001 

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:

评价中药治疗新型冠状病毒感染的肺炎有效性和安全性。 

Objectives of Study:

To evaluate the efficacy and safety of traditional Chinese medicine in the treatment of Severe pneumonia caused by new coronavirus. 

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; 2) 符合《方案》中新型冠状病毒感染的肺炎重型患者的诊断标准; 3) 知情同意书。 

Inclusion criteria

1) Aged >= 18 years; 2) Meet the diagnostic criteria of severe pneumonia patients with new coronavirus; 3) The informed consent form. 

排除标准:

1) 影响生存的严重基础疾病,包括:未控制已经多处转移不能切除的恶性肿瘤、血液病、恶液质、活动性出血、严重营养不良、HIV等; 2) 肺部肿瘤致阻塞性肺炎、严重肺间质纤维化、肺泡蛋白沉积症、过敏性肺泡炎者; 3) 近6个月内持续使用免疫抑制剂,或器官移植者; 4) 妊娠或哺乳期妇女; 5) 可能存在的潜在的违背试验依从性或者影响安全性和有效性评价的其他任何情况,研究者认为不适合参加研究的患者。 

Exclusion criteria:

1) Severe basic diseases that affect survival, including: uncontrolled malignant tumors with multiple metastases that cannot be removed, hematological diseases, cachexia, active bleeding, severe malnutrition, HIV, etc.; 2) Obstructive pneumonia caused by lung tumors, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic reaction alveolitis; 3) Previous immunosuppressive agents within 6 months before study entry or recipients of a solid-organ or bone marrow transplant; 4) Pregnant or lactating women; 5) Researchers believe that patients may have other factors affecting the efficacy or safety evaluation of this study. 

研究实施时间:

Study execute time:

From2020-02-03To 2020-08-31 

干预措施:

Interventions:

组别:

试验组

样本量:

28

Group:

Experimental Group

Sample size:

干预措施:

中西医联合治疗

干预措施代码:

Intervention:

Combined Treatment of Chinese medicine and western medicine

Intervention code:

组别:

对照组

样本量:

14

Group:

Control Group

Sample size:

干预措施:

西医治疗

干预措施代码:

Intervention:

Western medicine treatment

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):

湖北省中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

Hubei Provincial Hospital of Integrated Chinese and Western Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

转危重型率

指标类型:

主要指标 

Outcome:

Critically ill patients (%)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

氧合指数

指标类型:

次要指标 

Outcome:

Oxygenation 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:

降钙素原

指标类型:

次要指标 

Outcome:

PCT

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗生素使用百分率

指标类型:

次要指标 

Outcome:

Antibiotic use

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:

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:

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):

委托第三方公司,采用简单随机化方法产生随机序列。

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

Entrusting a third-party company, using a simple randomization method to generate random sequences.

盲法:

未说明

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):

公开数据的时间为试验完成后的6个月内,方式为:联系统计师

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

The time to disclose the data is within 6 months of the completion of the trial by: Contacting the statistician

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:

委托第三方

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

Entrusting a third-party company

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-01-30
返回列表