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A medical records based study for the curative effect of combined traditional Chinese and western medicine in the treatment of severe novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000032040 

最近更新日期:

Date of Last Refreshed on:

2020-04-20 

注册时间:

Date of Registration:

2020-04-18 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

中西医结合治疗对重型新型冠状病毒肺炎(COVID-19)的疗效:基于病历记录的研究 

Public title:

A medical records based study for the curative effect of combined traditional Chinese and western medicine in the treatment of severe novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中西医结合治疗对重型新型冠状病毒肺炎(COVID-19)的疗效观察 

Scientific title:

Observation of the curative effect of combined traditional Chinese and western medicine in the treatment of severe 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:

ChiMCTR2000003220 

申请注册联系人:

黄佳南 

研究负责人:

张媛莉 

Applicant:

Huang Jianan 

Study leader:

Zhang Yuanli 

申请注册联系人电话:

Applicant telephone:

+86 13676150172 

研究负责人电话:

Study leader's telephone:

+86 13828223316 

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:

2717513781@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangyuanly@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:

广东省湛江市霞山区新园街道文明东路2号 

研究负责人通讯地址:

广东省湛江市霞山区人民大道南57号 

Applicant address:

2 Wenming Road East, Xinyuan Street, Xiashan District, Zhanjiang, Guangdong, China 

Study leader's address:

57 Renmin Avenue South, Xiashan District, Zhanjiang, 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:

广东医科大学附属医院 

Applicant's institution:

Affiliated Hospital of Guangdong Medical University 

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:

PJ2020-026 

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:

广东医科大学附属医院机构审查伦理委员会 

Name of the ethic committee:

Review ethics committee of Affiliated Hospital of Guangdong Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-16 

伦理委员会联系人:

梁政 

Contact Name of the ethic committee:

Liang Zheng 

伦理委员会联系地址:

广东省湛江市霞山区人民大道南57号 

Contact Address of the ethic committee:

57 Renmin Avenue South, Xiashan District, Zhanjiang, 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:

广东医科大学附属医院 

Primary sponsor:

Affiliated Hospital of Guangdong Medical University 

研究实施负责(组长)单位地址:

广东省湛江市霞山区人民大道南57号 

Primary sponsor's address:

57 Renmin Avenue South, Xiashan District, Zhanjiang, Guangdong, 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):

广东省

市(区县):

湛江市

Country:

China

Province:

Guangdong

City:

Zhanjiang

单位(医院):

广东医科大学附属医院

具体地址:

广东省湛江市霞山区人民大道南57号

Institution
hospital:

Affiliated Hospital of Guangdong Medical University

Address:

57 Renmin Avenue South, Xiashan District

经费或物资来源:

湛江市科学技术局 

Source(s) of funding:

Zhanjiang municipal bureau of science and technology 

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:

观察性研究 

Study type:

Observational study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

本实验采用的中西医结合方法可有效地治疗重型新型冠状病毒肺炎患者,提高核酸转阴率,降低重型向危重型的转化,并能有效地降低重型新冠病毒肺炎患者的28天死亡率,同时此方案无明显临床不良反应。 

Objectives of Study:

In this study, the combination of traditional Chinese and western medicine can effectively treat severe COVID-19 patients, improve the nucleic acid conversion rate, reduce the conversion of severe to critical type, and effectively reduce the 28-day mortality of severe novel coronavirus pneumonia patients, without obvious clinical adverse reactions. 

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:

根据国家新型冠状病毒感染的肺炎诊疗方案第五版的临床分型,符合标准的新型冠状病毒肺炎患者 

Inclusion criteria

According to the clinical classification of the fifth edition of the national novel coronavirus pneumonia protocol, COVID 19 patients meet the standard 

排除标准:

1.年龄小于 18 岁患者 2.年龄大于75岁患者 3.妊娠患者 4.恶性肿瘤晚期患者 5.在重型期间使用糖皮质激素患者 6.其它抗逆转录病毒药物的患者 7.不愿签署知情同意书者 

Exclusion criteria:

Patients younger than 18 years of age, older than 75 years of age, pregnant patients, patients with advanced malignancies, patients taking glucocorticoids during severe periods, patients taking other antiretroviral drugs, and those unwilling to sign informed consent 

研究实施时间:

Study execute time:

From2020-03-01To 2020-08-01 

干预措施:

Interventions:

组别:

干预组

样本量:

30

Group:

Case series

Sample size:

干预措施:

皮下注射胸腺肽a1, 服用麻杏石甘汤和银翘散加减

干预措施代码:

Intervention:

Subcutaneous injection of thymosin a1, take Ma-Xing-Shi-Gan tang and Yin-Qiao powder plus or minus

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

湛江市 

Country:

China 

Province:

guangdong province 

City:

zhanjiang city 

单位(医院):

广东医科大学附属医院 

单位级别:

三甲 

Institution
hospital:

Affiliated hospital of guangdong medical university  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

28天死亡率

指标类型:

主要指标 

Outcome:

28-day mortality

Type:

Primary 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 75 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):

N/A

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 ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

学术期刊

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

Academic journal

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:

临床试验机构应当保存临床试验资料至临床试验结束后 10 年;申办者应当保存临床试验资料至无该医疗器械使用时。这些数据交由有资质的数据管理方按照与申办方协商制定的《数据管理计划》进行数据管理和清理。

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

All raw data should be preserved at their respective clinical trial sites for up to 10 years and by the study sponsor until such medical device is no longer in use. Data will be processed and managed by a qualified third-party data management provider in accordance with Data Management Plan agreed upon by both parties.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-04-18
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