今天是:2020-03-30 星期一

大剂量痰热清注射液治疗新型冠状病毒肺炎(COVID-19)真实世界临床研究
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注册号:

Registration number:

ChiCTR2000029432 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

大剂量痰热清注射液治疗新型冠状病毒肺炎(COVID-19)真实世界临床研究 

Public title:

A Real World Study for the Efficacy and Safety of Large Dose Tanreqing Injection in the Treatment of Patients with Novel Coronavirus Pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

大剂量痰热清注射液治疗新型冠状病毒肺炎(COVID-19)真实世界临床研究 

Scientific title:

A Real World Study For the Efficacy and Safety of Large Dose Tanreqing Injection in the Treatment of Patients with 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:

ChiMCTR2000002948 

申请注册联系人:

杜彦萍 

研究负责人:

杨忠奇,温敏勇 

Applicant:

Yanping Du 

Study leader:

Zhongqi Yang, Minyong Wen 

申请注册联系人电话:

Applicant telephone:

+86 15889951600; 020-36591127 

研究负责人电话:

Study leader's telephone:

+86 13688867618 

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:

dp7285@126.com 

研究负责人电子邮件:

Study leader's E-mail:

yang_zhongqi@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:

广东省广州市白云区机场路16号 

研究负责人通讯地址:

广东省广州市白云区机场路16号 

Applicant address:

16 Jichang Road, Baiyun District, Guangzhou, Guangdong, China  

Study leader's address:

16 Jichang Road, Baiyun District, Guangzhou, Guangdong, 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:

广州中医药大学第一附属医院 

Applicant's institution:

The First Afflicated Hospital of Guangzhou 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:

NO.K【2020】011 

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:

广州中医药大学第一附属医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Guangzhou 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:

黎欣盈 

Contact Name of the ethic committee:

Xinying Li 

伦理委员会联系地址:

广州市白云区机场路16号 

Contact Address of the ethic committee:

16 Jichang Road, Baiyun District, Guangzhou, Guangdong, 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:

广州中医药大学第一附属医院 

Primary sponsor:

The First Afflicated Hospital of Guangzhou University of Chinese Medicine  

研究实施负责(组长)单位地址:

广东省广州市白云区机场路16号 

Primary sponsor's address:

16 Jichang Road, Baiyun District, Guangzhou, Guangdong, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

无 

Source(s) of funding:

N/A 

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:

观察大剂量中药注射液治疗新型冠状病毒感染肺炎临床疗效及其安全性;期望形成疗效确切、方便推广的中医治疗方案。 

Objectives of Study:

Observe the efficacy and safety of large dose tanreqing injection in patients with novel coronavirus pneumonia. It is expected to form a Chinese medicine treatment with definite curative effect and convenient promotion. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1.符合《新型冠状病毒感染的肺炎诊疗方案(试行第四版)》新型冠状病毒感染肺炎诊断标准确诊或疑似病例: 2.年龄在18-75岁之间,住院病人; 3.获得知情同意。 

Inclusion criteria

1. Confirmed or suspected cases who are comply with the diagnostic criteria for pneumonia caused by novel coronavirus infection in the "Diagnosis and Treatment Program for pneumonia caused by novel coronavirus infection (Trial Version 4)"; 2. Inpatients aged 18-75 years; 3. Obtain the informed consent form.  

排除标准:

1.排除危重型新型冠状病毒感染肺炎; 2.排除其他合并严重疾病; 3.排除不符合参加临床研究的其他情况如精神异常、妊娠期或哺乳期妇女、有药物滥用或依赖史、对研究用药过敏、3个月内参加过其他临床研究等。 

Exclusion criteria:

1. Patients with severe novel coronavirus pneumonia; 2. Patients with severe basic diseases; 3. Patients who have mental confusion, pregnant or lactating women, who with a history of drug abuse or dependence, who allergic to study medication, who have participated in another clinical trial within 3 months,or who have other conditions not suitable for clinical study. 

研究实施时间:

Study execute time:

From2020-02-01To 2020-04-30 

干预措施:

Interventions:

组别:

干预组

样本量:

72

Group:

Case series

Sample size:

干预措施:

痰热清注射液加入5%葡萄糖注射液或0.9%氯化钠注射液500ml,静脉滴注,控制滴数每分钟不超过60滴,每日1-2次;使用剂量由医生根据临床情况决定,建议40ml/天或以上,但最多不得超过80ml/天

干预措施代码:

Intervention:

Add 500ml of 5% glucose injection or 0.9% sodium chloride injection into Tanreqing injection, intravenous drip, control the number of drops no more than 60 drops per minute, 1-2 times a day; the dosage is determined by the doctor,but no more than 80ml / day, 40ml / day is recommended.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州中医药大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

The First Afflicated Hospital of Guangzhou University of Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

体温复常时间

指标类型:

主要指标 

Outcome:

Time for body temperature recovery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺炎胸片吸收情况

指标类型:

主要指标 

Outcome:

Chest X-ray absorption

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

次要指标 

Outcome:

Routine blood test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生化指标

指标类型:

次要指标 

Outcome:

Biochemical Indicators

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血气分析

指标类型:

次要指标 

Outcome:

Blood gas analysis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

次要指标 

Outcome:

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:

降钙素原

指标类型:

次要指标 

Outcome:

Procalcitonin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心酶

指标类型:

次要指标 

Outcome:

Heart enzyme 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:

肝肾功能

指标类型:

次要指标 

Outcome:

Liver and renal function

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 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):

不进行随机分组

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

N/A

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):

不公开

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

Private

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 Report Form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-01
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