今天是:2020-04-08 星期三

中西医结合治疗儿童新型冠状病毒肺炎(COVID-19) 的临床研究
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注册号:

Registration number:

ChiCTR2000029814 

最近更新日期:

Date of Last Refreshed on:

2020-02-14 

注册时间:

Date of Registration:

2020-02-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中西医结合治疗儿童新型冠状病毒肺炎(COVID-19) 的临床研究 

Public title:

Clinical Trial for Integrated Chinese and Western Medicine in the Treatment of Children 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:

中西医结合治疗儿童新型冠状病毒肺炎(COVID-19) 的临床研究 

Scientific title:

Clinical Trial for Integrated Chinese and Western Medicine in the Treatment of Children 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:

ChiMCTR2000003013 

申请注册联系人:

曹迪 

研究负责人:

翟晓文 

Applicant:

Cao Di 

Study leader:

Zhai Xiaowen 

申请注册联系人电话:

Applicant telephone:

+86 18017591115 

研究负责人电话:

Study leader's telephone:

+86 64931902 

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:

cdragon98@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhaixiaowendy@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:

上海市闵行区万源路399号 

研究负责人通讯地址:

上海市闵行区万源路399号 

Applicant address:

399 Wanyuan Road, Minhang District, Shanghai 

Study leader's address:

399 Wanyuan Road, Minhang District, Shanghai 

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:

复旦大学附属儿科医院 

Applicant's institution:

Children's Hospital of Fudan 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:

复儿伦理[2020]30号 

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:

复旦大学附属儿科医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Children's Hospital of Fudan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-11 

伦理委员会联系人:

陆毅群 

Contact Name of the ethic committee:

Lu Yiqun 

伦理委员会联系地址:

上海市闵行区万源路399号 

Contact Address of the ethic committee:

399 Wanyuan Road, Minhang District, Shanghai 

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:

复旦大学附属儿科医院 

Primary sponsor:

Children's Hospital of Fudan University 

研究实施负责(组长)单位地址:

上海市闵行区万源路399号 

Primary sponsor's address:

399 Wanyuan Road, Minhang District, Shanghai 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属儿科医院

具体地址:

闵行区万源路399号

Institution
hospital:

Children's Hospital of Fudan University

Address:

399 Wanyuan Road, Minhang District

经费或物资来源:

政府,医院 

Source(s) of funding:

Government, Hospital 

研究疾病:

新型冠状病毒肺炎 

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:

(1)补充国家及上海方案中缺乏的儿科新型冠状病毒肺炎的临床特点、中医证候、理化特征; (2)观察采用中西医结合诊疗方案对不同年龄及不同病情儿科患儿的疗效及临床预后(退热时间、重症转化率、病毒核酸转阴时间、呼吸道症状改善情况、临床检验指标改善情况)等; (3)在国家方案基础上,优化形成适合儿科的新型冠状病毒肺炎儿童患儿中西医结合诊疗方案; 

Objectives of Study:

(1) Supplement the clinical features, TCM syndromes, and physical and chemical characteristics of pediatric new coronavirus pneumonia that are lacking in national and Shanghai programs; (2) To observe the curative effect and clinical prognosis of pediatric patients of different ages and conditions (combined with antipyretic time, severe conversion rate, viral nucleic acid negative time, improvement of respiratory symptoms, and improvement of clinical indicators) using the integrated Chinese and western medicine diagnosis and treatment plan Wait; (3) On the basis of the national plan, optimize the integration of traditional Chinese and western medicine diagnosis and treatment plan for children with new type of coronavirus pneumonia suitable for pediatrics; 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

通过流行病学史、临床症状以及核酸检测结果被确诊为新型冠状病毒肺炎的儿童患者。 

Inclusion criteria

Children diagnosed with novel coronavirus pneumonia through epidemiological history, clinical symptoms, and nucleic acid test results. 

排除标准:

无 

Exclusion criteria:

No exclusion criteria 

研究实施时间:

Study execute time:

From2020-02-14To 2020-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

15

Group:

control group

Sample size:

干预措施:

西药治疗

干预措施代码:

Intervention:

Western Medicine

Intervention code:

组别:

试验组

样本量:

15

Group:

experimental group

Sample size:

干预措施:

中西医结合治疗

干预措施代码:

Intervention:

Integrated Traditional Chinese and Western Medicine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属儿科医院 

单位级别:

三级甲等 

Institution
hospital:

Children's Hospital of Fudan University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

退热时间

指标类型:

主要指标 

Outcome:

Time fo fever reduction

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

核酸转阴时间

指标类型:

主要指标 

Outcome:

Time of nucleic acid negative

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

重症转化率

指标类型:

主要指标 

Outcome:

Severe conversion rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸道症状改善时间

指标类型:

主要指标 

Outcome:

Improvement time of respiratory symptoms

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

药品不良反应

指标类型:

次要指标 

Outcome:

ADR

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:

鼻咽拭子

组织:

Sample Name:

nasopharyngeal swab

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:

痰液

组织:

Sample Name:

sputum

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:

鼻咽吸取液

组织:

Sample Name:

nasopharynx secretion

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:

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 0 years
最大 Max age 18 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):

未使用

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

Not used

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:

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-14
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