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Clinical study for ozonated autohemotherapy in the treatment of Novel Coronavirus Pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030165 

最近更新日期:

Date of Last Refreshed on:

2020-02-24 

注册时间:

Date of Registration:

2020-02-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

医用三氧自体血疗法治疗新冠病毒肺炎(COVID-19)患者的临床研究 

Public title:

Clinical study for ozonated autohemotherapy 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:

医用三氧自体血疗法治疗新冠病毒肺炎(COVID-19)患者的临床研究 

Scientific title:

Clinical study for ozonated autohemotherapy 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:

倪广健 

研究负责人:

于洪志 

Applicant:

Ni Guangjian 

Study leader:

Yu Hongzhi 

申请注册联系人电话:

Applicant telephone:

+86 22 83612122 

研究负责人电话:

Study leader's telephone:

+86 22 58830026 

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:

niguangjian@tju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

ykb@tju.edu.cn 

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:

天津市南开区卫津路92号 

研究负责人通讯地址:

天津市津南区津沽路890号 

Applicant address:

92 Weijin Road, Nankai District, Tianjin, China 

Study leader's address:

890 Jin'gu Road, Jinnan District, Tianjin, China 

申请注册联系人邮政编码:

Applicant postcode:

300072 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

天津大学医工院 

Applicant's institution:

Academy of Medical Engineering and Translational Medicine, Tianjin 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:

2020HHKT-009 

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:

天津市海河医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Tianjin Haihe hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-23 

伦理委员会联系人:

王露 

Contact Name of the ethic committee:

Wang Lu 

伦理委员会联系地址:

天津市津南区津沽路890号天津市津南区海河医院 

Contact Address of the ethic committee:

890 Jin'gu Road, Jinnan District, Tianjin, 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:

天津大学 

Primary sponsor:

Tianjin University 

研究实施负责(组长)单位地址:

天津市津南区津沽路890号 

Primary sponsor's address:

890 Jin'gu Road, Jinnan District, Tianjin, 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):

天津

市(区县):

津南区

Country:

China

Province:

Tianjin

City:

Jinnan District

单位(医院):

天津大学海河医院

具体地址:

天津市津南区双港镇津沽路890号

Institution
hospital:

Haihe hospital, Tianjin University

Address:

890 Jin'gu Road, Jinnan District

国家:

中国

省(直辖市):

天津

市(区县):

南开区

Country:

China

Province:

Tianjin

City:

Nankai District

单位(医院):

天津大学医学部

具体地址:

天津市南开区天津大学

Institution
hospital:

Medical College of Tianjin University

Address:

92 Weijin Road, Nankai District

经费或物资来源:

财政支持 

Source(s) of funding:

Governmental financial support  

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:

探讨医用三氧自体血疗法疗法对新型冠状病毒肺炎患者的临床有效性 

Objectives of Study:

Study the therapeutic effects of ozonated autohemotherapy in the treatment of 2019 Novel Coronavirus Pneumonia (COVID-19).  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1)确诊患者(或法律监护人)同意参加本研究并签署知情同意书; 2)18≤年龄≤80周岁,性别不限; 3)呼吸道标本或血液标本实时荧光RT-PCR检测新型冠状病毒核酸阳性患者; 4)根据《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》的普通型、重型型和危重型的病例 

Inclusion criteria

(1) Confirmed patients (or legal guardian) sign a written informed consent form; (2) Aged from 18 to 80 years, male or female; (3) Patients with positive detection of 2019 Novel Coronavirus Pneumonia fluorescence RT-PCR in respiratory specimens or blood samples; (4) Mild ill, severe ill and critical ill patients are grouped based on the fifth edition of the treatment and diagnosis plan published by the National Health Commission of the Peoples Republic of China. 

排除标准:

1)患者可能在72h内转至非参与医院; 2)葡萄糖-6磷酸脱氢酶(G-6PD)明显缺陷(蚕豆病); 3)怀孕尤其是怀孕早期; 4)近 6个月内持续使用免疫抑制剂,或器官移植者; 5)甲状腺机能亢进; 6)对三氧(臭氧)过敏者; 7)正参加其它临床试验者。 

Exclusion criteria:

1) Patients who may be transferred to other hospitals that are not included in the trial within 72 hours; 2) G-6PD defect (Favism); 3) Pregnancy, especially early pregnancy; 4) Patients who continually use immunosuppressant, or are organ transplant recipients within 6 months; 5) Hyperthyroidism; 6) Patients with medical ozone allergy; 7) Patients who are receiving other clinical trials. 

研究实施时间:

Study execute time:

From2020-02-22To 2020-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

conventional treatment

Intervention code:

组别:

普通型治疗组

样本量:

15

Group:

mild ill patients

Sample size:

干预措施:

常规治疗+臭氧自血疗法

干预措施代码:

Intervention:

conventional treatment and ozonated autohemotherapy

Intervention code:

组别:

重型/危重型治疗组

样本量:

15

Group:

severe/critical ill patients

Sample size:

干预措施:

常规治疗+臭氧自血疗法

干预措施代码:

Intervention:

conventional treatment and ozonated autohemotherapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津 

市(区县):

津南区 

Country:

China 

Province:

Tianjin 

City:

Jinnan District 

单位(医院):

天津大学海河医院 

单位级别:

三级甲等 

Institution
hospital:

Haihe Hospital, Tianjin University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

胸部CT

指标类型:

主要指标 

Outcome:

Chest CT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全血细胞分析

指标类型:

主要指标 

Outcome:

Whole blood cell analysis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治愈率

指标类型:

主要指标 

Outcome:

Recovery 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:

重症转换率

指标类型:

次要指标 

Outcome:

Conversion rate of severe patients

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

氧合指数

指标类型:

主要指标 

Outcome:

Oxygenation index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎症反应指标

指标类型:

主要指标 

Outcome:

Inflammatory response index

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:

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 80 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):

非随机

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

Non random

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):

共享的公共平台为临床研究公共管理平台(ResMan), http://www.medresman.org.cn.

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

The public management platform for clinical research (ResMan), http://www.medresman.org.cn.

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:

(1)病例记录表; (2)电子采集和管理系统

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

(1)Case Record Form, CRF; (2)Electronic Data Capture, EDC1

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-24
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