今天是:2020-03-30 星期一

糖皮质激素治疗重症新型冠状病毒肺炎疗效与安全性的随机对照研究
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注册号:

Registration number:

ChiCTR2000029386 

最近更新日期:

Date of Last Refreshed on:

2020-03-02 

注册时间:

Date of Registration:

2020-01-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

糖皮质激素治疗重症新型冠状病毒肺炎疗效与安全性的随机对照研究 

Public title:

Effectiveness of glucocorticoid therapy in patients with severe novel coronavirus pneumonia: a randomized controlled trial  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型冠状病毒肺炎临床救治策略研究与应用 

Scientific title:

A study on treatment strategies of novel coronavirus pnueumonia patients  

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:

秦圆圆 

研究负责人:

陈耀凯 

Applicant:

Yuanyuan Qin 

Study leader:

Yaokai Chen 

申请注册联系人电话:

Applicant telephone:

+86 15922752784 

研究负责人电话:

Study leader's telephone:

+86 13638352995 

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:

qin_yuanyuan@outlook.com 

研究负责人电子邮件:

Study leader's E-mail:

yaokaichen@hotmail.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:

重庆市沙坪坝区歌乐山镇保育路109号 

研究负责人通讯地址:

重庆市沙坪坝区歌乐山镇保育路109号 

Applicant address:

109 Baoyu Road, Shapingba District, Chongqing, China 

Study leader's address:

109 Baoyu Road, Shapingba District, Chongqing, 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:

重庆市公共卫生医疗救治中心 

Applicant's institution:

Chongqing Public Health Medical Center 

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:

2020-003-02-KY 

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:

重庆市公共卫生医疗救治中心伦理委员会 

Name of the ethic committee:

The Ethic Committee of Chongqing Public Health Medical Center 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-28 

伦理委员会联系人:

陈亚玲 

Contact Name of the ethic committee:

Yaling Chen 

伦理委员会联系地址:

重庆市沙坪坝区歌乐山镇保育路109号 

Contact Address of the ethic committee:

109 Baoyu Road, Geleshan Town, Shapingba District, Chongqing, 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:

重庆市公共卫生医疗救治中心 

Primary sponsor:

Chongqing Public Health Medical Center 

研究实施负责(组长)单位地址:

重庆市沙坪坝区歌乐山镇保育路109号 

Primary sponsor's address:

109 Baoyu Road, Shapingba District, Chongqing, 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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆市公共卫生医疗救治中心

具体地址:

重庆市沙坪坝区歌乐山镇保育路109号

Institution
hospital:

Chongqing Public Health Medical Center

Address:

109 Baoyu Road, Shapingba District, Chongqing, China

经费或物资来源:

重庆市科学技术局 

Source(s) of funding:

Chongqing Science and Technology of Bureau 

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:

其它 

Study phase:

N/A 

研究目的:

评价激素应用于重度新型冠状病毒感染的疗效与安全性,探索最优治疗模式 

Objectives of Study:

To evaluate the efficacy and safety of adjunctive corticosteroid therapy for patients with severe novel coronavirus pneumonia and to discover the optimal treatment model. 

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岁; ②经病原学检测确诊的新型冠状病毒感染; ③重度肺炎符合以下情况之一者: a.呼吸窘迫(≥30 次/分); b.静息状态下指氧饱和度≤93%; c.动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg (1mmHg=0.133kPa); d.出现呼吸衰竭,且需要机械通气; e.出现休克; f.合并其他器官功能衰竭需ICU监护治疗。 ④签署知情同意书。 

Inclusion criteria

1. Male or female over 18 years of age; 2. Novel coronavirus infection is confirmed by pathogenic detection; 3. The diagnosis of severe coronavirus pneumonia will have to meet at least one of the following criteria: (1) Respiratory distress, RR>30 times/minute (2) In the state of no oxygen at rest, the patient's SPO2<=93% (3) Oxygenation Index (PaO2/FiO2)<=300 mmHg (1mmHg=0.133kPa); (4) Respiratory failure requiring mechanical ventilation; (5) Sepsis; (6) Other organ failure requiring ICU care. 4. Be willing to give the informed consent. 

排除标准:

①对研究药物过敏或不耐受者; ②孕妇或哺乳期女性; ③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者。 

Exclusion criteria:

1. Patients are allergic or intolerant to therapeutic drugs; 2. Pregnancy or lactating women; 3. 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:

From2020-01-29To 2021-01-29 

干预措施:

Interventions:

组别:

干预组

样本量:

24

Group:

Experimental group

Sample size:

干预措施:

甲泼尼龙 静脉注射 1~2mg/kg·d 持续3天。

干预措施代码:

Intervention:

Methylprednisolone, intravenous injection, 1-2mg/kg·d for 3 days.

Intervention code:

组别:

对照组

样本量:

24

Group:

Control group

Sample size:

干预措施:

不使用任何糖皮质激素

干预措施代码:

Intervention:

Without any glucocorticoid therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆市公共卫生医疗救治中心 

单位级别:

三级医院 

Institution
hospital:

Chongqing Public Health Medical Center  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

SOFA评分

指标类型:

主要指标 

Outcome:

SOFA score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时长

指标类型:

次要指标 

Outcome:

Duration of hospitalization

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

机械通气比例

指标类型:

次要指标 

Outcome:

Proportion of mechanical ventilation use

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

死亡率

指标类型:

次要指标 

Outcome:

Mortality

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:

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):

由研究负责人进行临床诊断后确定纳入研究的受试者,再由第三方统计人员运用Excel软件,采用随机数字表法生成随机方案。

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

Subjects included in the study after clinical diagnosis by the research leader, then the third-party statisticians use Excel to generate random schemes by random number table method.

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:

即时公开/Real time access

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):

研究完成后,我们将通过发表的医学期刊文章和会议报告f分享研究结果。

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

We will share the results through published medical journal articles and at conference presentation after completion of the study.

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:

所有数据将记录在病例报告表(CRF)上,并通过医学研究平台立即记录在数据库中。

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

ll data will be documented on case report forms (CRFs) and immediately recorded in the database through the Medical Research Platform.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-01-29
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