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新型冠状病毒肺炎(COVID-19)代谢异常及其重编逆转治疗的研究
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注册号:

Registration number:

ChiCTR2000031271 

最近更新日期:

Date of Last Refreshed on:

2020-03-26 

注册时间:

Date of Registration:

2020-03-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型冠状病毒肺炎(COVID-19)代谢异常及其重编逆转治疗的研究 

Public title:

Metabolic abnormalities and rearrangement reversal treatment of patient 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:

新型冠状病毒肺炎(COVID-19)代谢异常及其重编逆转治疗的研究 

Scientific title:

Metabolic abnormalities and rearrangement reversal treatment of patient 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:

 

申请注册联系人:

陈壮桂 

研究负责人:

陈壮桂 

Applicant:

Zhuang-Gui Chen 

Study leader:

Zhuang-Gui Chen 

申请注册联系人电话:

Applicant telephone:

+86 13600009221 

研究负责人电话:

Study leader's telephone:

+86 13600009221 

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:

chenzhuanggui@126.com 

研究负责人电子邮件:

Study leader's E-mail:

chenzhuanggui@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:

广州市天河路600号中山大学附属第三医院儿科 

研究负责人通讯地址:

广州市天河路600号 

Applicant address:

600 Tianhe Road, Tianhe District, Guangzhou, Guangdong, China 

Study leader's address:

600 Tianhe Road, Tianhe 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:

中山大学附属第三医院 

Applicant's institution:

The Third Affiliated Hospital of Sun Yat-sen 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:

[2020]02-037 

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:

中山大学附属第三医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of the Third Affiliated Hospital of Sun Yat-sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-12 

伦理委员会联系人:

黄凯琪 

Contact Name of the ethic committee:

Kai-Qi Huang 

伦理委员会联系地址:

广州市天河路600号中山大学附属第三医院 

Contact Address of the ethic committee:

The Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe 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:

中山大学附属第三医院 

Primary sponsor:

The Third Affiliated Hospital of Sun Yat-sen University 

研究实施负责(组长)单位地址:

广州市天河路600号中山大学附属第三医院 

Primary sponsor's address:

600 Tianhe Road, Tianhe District, Guangzhou, 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):

Country:

China

Province:

Guangdong

City:

单位(医院):

中山大学附属第三医院

具体地址:

广东省广州市天河区天河路600号

Institution
hospital:

The Third Affiliated Hospital of Sun Yat-sen University,

Address:

600 Tianhe Road, Tianhe District, Guangzhou

经费或物资来源:

中山大学 2020 年度 “三大 ”建设大科研项目 

Source(s) of funding:

Three major scientific research projects of Sun Yat sen University in 2020 

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:

开展COVID-19感染肺炎患者的代谢机制与代谢组重编调节研究,揭示患者发病的代谢机制的基础上,发现关键代谢通路,鉴定关键生物标志物,迅速研制代谢组重编新药,用于重编患者代谢组, 创建COVID-19感染肺炎患者的治疗新方法,并为将来相关的感染性疾病提供新的治疗范例和策略。 

Objectives of Study:

To carry out the research on the metabolic mechanism and metabolomic group rearrangement regulation of patients with covid-19 pneumonia, reveal the metabolic mechanism of patients, find out the key metabolic pathways, identify the key biomarkers, and rapidly develop the new drug of metabolomic group rearrangement, which is used to rearrange the metabolomic group of patients, Create a new treatment method for patients with covid-19 infection pneumonia, and provide new treatment examples and strategies for future related infectious diseases. 

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:

入选受试者年龄 18-65 岁,性别不限,符合国家卫健委《新型冠状病毒感染的肺炎诊疗方案(试行第 7 版)》修订诊断标准。 

Inclusion criteria

Novel coronavirus pneumonia diagnosis and treatment plan (trial version seventh) was revised to meet the diagnostic criteria of the 18-65 year old patients 

排除标准:

(1)基础病:发病前合并严重糖尿病、心肺功能不全、慢性肾病、慢性肝功能不全肝硬化等患者;肿瘤患者;合并氮质血症者; (2)不愿意参加试验者; 

Exclusion criteria:

(1) Basic diseases: Patients with severe diabetes, cardiopulmonary insufficiency, chronic kidney disease, chronic liver failure, cirrhosis, etc. before onset; tumor patients; patients with azotemia; (2) Not willing to participate in the experiment; 

研究实施时间:

Study execute time:

From2020-04-01To 2021-03-31 

干预措施:

Interventions:

组别:

对照

样本量:

40

Group:

Control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

regular treatment

Intervention code:

组别:

试验

样本量:

40

Group:

Experimental group

Sample size:

干预措施:

复方氨基酸联合常规治疗

干预措施代码:

Intervention:

Compound amino acid combined with routine treatment

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):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

中山大学附属第三医院 

单位级别:

三甲医院 

Institution
hospital:

The Third Affiliated Hospital of Sun Yat-sen University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

住院日或实验组死亡比/对照组死亡比

指标类型:

主要指标 

Outcome:

Hospital stay or death ratio of experimental group / death ratio of control group

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SOFA评分

指标类型:

次要指标 

Outcome:

SOFA

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清炎症因子浓度

指标类型:

次要指标 

Outcome:

Serum inflammatory factor concentration

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ICU 住院天数

指标类型:

次要指标 

Outcome:

ICU inpatient days

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

90 天随访生活质量评估

指标类型:

次要指标 

Outcome:

Quality of life assessment in 90 day follow-up

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:

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 18 years
最大 Max age 65 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):

随机分组:分层区组随机分组 (a)根据计算所需的样本量(n),将 1 至 n 个序列号 (b)区的大小:为 2 或 4,由另一组随机数字顺序的单双数决定,单数时区的大小为 2,双数时为 4。将 1-n 个序列号按顺序分层若干区,最后一个区如果超过 n 时,可以增加 2 个样本量。 (c)采用 SAS 软件给 1-n 个序列号各生成一个随机数字,按区分层,按随机数字大小分层人数相等的两组,编号为 A 和 B 组。A 组为实验组,B 组为对照组。

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

SAS software will be used to generate random number by stratified block randomization and the length of block will be 2 or 4.

盲法:

未说明

Blinding:

Not stated

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):

2021年10月通过Resman公开

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

Published by resman in October 2021(www.medresman.org)

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 Record Form, CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-03-26
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