今天是:2020-05-29 星期五

以巨噬细胞为靶点抗新型冠状病毒肺炎(COVID-19)治疗方法的临床研究
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注册号:

Registration number:

ChiCTR2000029431 

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:

以巨噬细胞为靶点抗新型冠状病毒肺炎(COVID-19)治疗方法的临床研究 

Public title:

Clinical study for the remedy of M1 macrophages target in the treatment of novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

以巨噬细胞为靶点抗新型冠状病毒肺炎(COVID-19)治疗方法的临床研究 

Scientific title:

Clinical study of type I macrophages therapy in the treatment of 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:

 

申请注册联系人:

马志杰 

研究负责人:

赵德伟 

Applicant:

Zhijie Ma 

Study leader:

Dewei Zhao 

申请注册联系人电话:

Applicant telephone:

+86 18842857788 

研究负责人电话:

Study leader's telephone:

+86 0411-62893509 

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:

DLDXMZJ@163.COM 

研究负责人电子邮件:

Study leader's E-mail:

zhaodewei2016@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:

辽宁省大连市中山区解放街6号 

研究负责人通讯地址:

辽宁省大连市中山区解放街6号 

Applicant address:

6 Jiefang Street, Dalian, Liaoning, China  

Study leader's address:

6 Jiefang Street, Dalian, Liaoning, 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:

大连大学附属中山医院 

Applicant's institution:

Affiliated Zhongshan Hospital of Dalian 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:

2020003 

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:

大连大学附属中山医院伦理委员会 

Name of the ethic committee:

Zhongshan Hospital Affiliated to Dalian University ethics committee  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-29 

伦理委员会联系人:

张桂琴 

Contact Name of the ethic committee:

Guiqin Zhang 

伦理委员会联系地址:

辽宁省大连市中山区解放街6号 

Contact Address of the ethic committee:

6 Jiefang Street, Dalian, Liaoning, 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:

大连大学附属中山医院 

Primary sponsor:

Affiliated Zhongshan Hospital of Dalian University  

研究实施负责(组长)单位地址:

辽宁省大连市中山区解放街6号 

Primary sponsor's address:

6 Jiefang Street, Dalian, Liaoning, 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):

辽宁

市(区县):

大连

Country:

China

Province:

Liaoning

City:

Dalian

单位(医院):

大连大学附属中山医院

具体地址:

辽宁省大连市中山区解放街6号

Institution
hospital:

Affiliated Zhongshan Hospital of Dalian University

Address:

6 Jiefang Street

经费或物资来源:

自筹 

Source(s) of funding:

Self-raised 

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:

研究一种可以用于2019-nCoV感染肺炎综合治疗的M1(I型巨噬细胞)抑制疗法并评估其临床疗效;并评估其对激素性骨坏死的预防效果。 

Objectives of Study:

Study a M1 (type I macrophage) inhibition therapy for 2019-nCoV treatment and evaluate its clinical efficacy;and evaluate its preventive effect on hormonal osteonecrosis. 

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 2020年 1 月至 2020 年 12 月在大连大学附属中山医院及武汉大学中南医院就诊的新型冠状病毒2019-nCoV感染患者; ② nCoV 核酸阳性; ③ 年龄≧18周岁,性别不限; ④ 患者理解试验目的,自愿签署知情同意书,并同意按照方案要求完成整改研究过程者 

Inclusion criteria

1. 2019-nCoV infected patients treated at Affiliated Zhongshan Hospital of Dalian University and Zhongnan Hospital of Wuhan University from January 2020 to December 2020 2. nCoV nucleic acid positive; 3. Aged >=18 years; 4. Patients understand the purpose of the trial, voluntarily sign informed consent, and agree to complete the rectification research process. 

排除标准:

① 过敏体质者; ② 有严重心脑血管疾病、糖尿病、精神及神经系统疾病、严重肝、肾功能不全等病史者; ③ 有髋、膝关节外伤或手术史者; ④ 滥用药物的患者; ⑤ 处于慢性疾病的急性发作期者; ⑥ 患有其他恶性疾病且生存期少于12个月的患者; ⑦ 妊娠、哺乳期妇女; ⑧ 依次性较差,不能按时进行随访者; ⑨ 近3个月内参加其他药物或器械的临床试验者。 

Exclusion criteria:

1. Those with allergies; 2. Patients with a history of severe cardio-cerebral vascular disease, diabetes, mental and neurological diseases, severe liver and renal insufficiency; 3. History of hip or knee trauma or surgery; 4. Patients who abuse drugs; 5. Those who are in the acute phase of chronic diseases; 6. Patients with other malignant diseases and a survival time of less than 12 months; 7. pregnancy,lactating women; 8. Poor compliance and unable to follow up on time; 9. Participants in clinical trials of other drugs or devices within the past 3 months. 

研究实施时间:

Study execute time:

From2020-01-29To 2021-12-31 

干预措施:

Interventions:

组别:

A

样本量:

15

Group:

A

Sample size:

干预措施:

重症期规范治疗+甲强龙

干预措施代码:

Intervention:

Critical Treatment in Critical Period + Ankylosaurus

Intervention code:

组别:

B

样本量:

15

Group:

B

Sample size:

干预措施:

重症期规范治疗+甲强龙+M1抑制治疗

干预措施代码:

Intervention:

Critical Treatment in Critical Period + Ankylosaurus+M1 suppression therapy

Intervention code:

组别:

C

样本量:

15

Group:

C

Sample size:

干预措施:

重症期规范治疗

干预措施代码:

Intervention:

Critical Treatment in Critical Period

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

辽宁省 

市(区县):

大连市 

Country:

China 

Province:

Liaoning 

City:

Dalian 

单位(医院):

大连大学附属中山医院 

单位级别:

三级甲等医院 

Institution
hospital:

Affiliated Zhongshan Hospital of Dalian University  

Level of the institution:

Tertiary A hospital 

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):

武汉大学中南医院 

单位级别:

三级甲等医院 

Institution
hospital:

Zhongnan Hospital of Wuhan University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

肺CT

指标类型:

主要指标 

Outcome:

CT of lung

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

髋关节CT和MRI

指标类型:

主要指标 

Outcome:

CT and MRI of hip

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:

标本中文名:

唾液

组织:

Sample Name:

Saliva

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 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):

平行随机

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

Parallel random

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):

2020.1.29;通过ResMan; 论文发表

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

2020.1.29; by ResMan; paper published

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:

原始数据、治疗过程及随访结果

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

Raw data, treatment process and follow-up results

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-01
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