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A multicenter randomized controlled trial for ozone autohemotherapy in the treatment of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030102 

最近更新日期:

Date of Last Refreshed on:

2020-02-23 

注册时间:

Date of Registration:

2020-02-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

黄慧玲医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。同时请尽快上传研究计划书、知情同意书模板。 医用三氧自血疗法治疗新冠病毒肺炎 (COVID-19) 患者的临床研究 

Public title:

A multicenter randomized controlled trial for ozone 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:

医用三氧自血疗法治疗新冠病毒肺炎 (COVID-19) 患者的多中心的临床研究 

Scientific title:

A multicenter randomized controlled trial for ozone 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:

黄慧玲 

研究负责人:

佟小光 

Applicant:

Huang Huiling 

Study leader:

Xiaoguang Tong 

申请注册联系人电话:

Applicant telephone:

+86 18622379741 

研究负责人电话:

Study leader's telephone:

+86 13820088121 

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:

huanghuiling@126.com 

研究负责人电子邮件:

Study leader's E-mail:

Tongxg@yahoo.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:

天津市津南区吉兆路6号 

研究负责人通讯地址:

天津市津南区吉兆路6号 

Applicant address:

6 Jizhao Road, Jinnan District, Tianjin 

Study leader's address:

6 Jizhao Road, Jinnan District, Tianjin 

申请注册联系人邮政编码:

Applicant postcode:

300320 

研究负责人邮政编码:

Study leader's postcode:

300320 

申请人所在单位:

天津市环湖医院 

Applicant's institution:

Tianjin Huanhu Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

天津市环湖医院 

Primary sponsor:

Tianjin Huanhu Hospital 

研究实施负责(组长)单位地址:

天津市津南区吉兆路6号 

Primary sponsor's address:

6 Jizhao Road, Jinnan District, Tianjin 

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):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津市环湖医院

具体地址:

津南区吉兆路6号

Institution
hospital:

Tianjin Huanhu Hospital

Address:

6 Jizhao Road, Jinnan District

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津市海河医院

具体地址:

津南区津沽路890号

Institution
hospital:

Tianjin Haihe Hospital

Address:

890 Jingu Road, Jinnan District

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):

中南医院

具体地址:

武昌区东湖路169号

Institution
hospital:

Zhounan Hopital

Address:

169 Donghu Road, Wuchang District

国家:

中国

省(直辖市):

湖北

市(区县):

恩施

Country:

China

Province:

Hubei

City:

Enshi

单位(医院):

恩施州中心医院

具体地址:

舞阳大道158号

Institution
hospital:

Enshi Central Hospital

Address:

158 Wuyang Road

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

新冠病毒肺炎 

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:

研究医用臭氧自血疗法治疗新冠病毒肺炎患者的有效性。 

Objectives of Study:

To Explore the Effectiveness of ozone autohemotherapy on Patients with COVID-19 Pneumonia. 

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)患者年龄18-80岁; 2)发病1周内; 3)符合《新型冠状病毒感染的肺炎诊疗方案(试行第六版)》普通型、重型和危重型的诊断标准; 4)签署知情同意书。 

Inclusion criteria

1. Aged 18-80 years; 2. Within 1 week of onset; 3. Meet the diagnostic criteria of common, severe and critical NCP, according to "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Pneumonia (Trial Version 6)". 4. Sign informed consent. 

排除标准:

1) 任何不能让方案安全进行的情况; 2) 患者可能在72h内转至非参与医院; 3) 近6个月内持续使用免疫抑制剂或器官移植者; 4) 葡萄糖-6-磷酸脱氢酶缺乏症(蚕豆病); 5) 在入组前住院期间使用任何方案中列出的正在研究的抗病毒药物治疗的患者; 6) 正参加其它临床试验者; 7)对臭氧过敏或高敏体质的。 

Exclusion criteria:

1. Any situation that does not allow the program to proceed safely; 2. The patient may be transferred to a non-participating hospital within 72 hours; 3. Those who have continued to use immunosuppressive agents or organ transplants for the past 6 months; 4. Glucose-6-phosphate dehydrogenation Enzyme deficiency (faba bean disease) 5; 5. Patients treated with any of the antiviral drugs listed in the protocol during hospitalization before enrollment; 6. Those participating in other clinical trials. 7. Those who are allergic to ozone or hypersensitive. 

研究实施时间:

Study execute time:

From2020-02-24To 2020-05-31 

征募观察对象时间:

Recruiting time:

From2020-02-24To 2020-05-31 

干预措施:

Interventions:

组别:

普通型对照组

样本量:

30

Group:

control group with common NCP

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

conventional treatment

Intervention code:

组别:

普通型试验组

样本量:

30

Group:

experimental group with common NCP

Sample size:

干预措施:

常规治疗+医用臭氧自血疗法

干预措施代码:

Intervention:

conventional treatment combined with ozone therapy

Intervention code:

组别:

重型试验组

样本量:

30

Group:

experimental group with severe NCP

Sample size:

干预措施:

常规治疗+医用臭氧自血疗法

干预措施代码:

Intervention:

conventional treatment combined with ozone therapy

Intervention code:

组别:

重型对照组

样本量:

30

Group:

control group with severe NCP

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

conventional treatment

Intervention code:

组别:

危重型试验组

样本量:

30

Group:

experimental group with critical NCP

Sample size:

干预措施:

常规治疗+医用臭氧自血疗法

干预措施代码:

Intervention:

conventional treatment combined with ozone therapy

Intervention code:

组别:

危重型对照组

样本量:

30

Group:

control group with critical NCP

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

conventional treatment

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):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市海河医院 

单位级别:

三等甲级 

Institution
hospital:

Tianjin Haihe Hospital  

Level of the institution:

Tertiary A 

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):

中南医院 

单位级别:

三级甲等 

Institution
hospital:

Zhongnan Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

湖北 

市(区县):

恩施 

Country:

China 

Province:

Hubei 

City:

Enshi 

单位(医院):

恩施州中心医院 

单位级别:

三级甲等 

Institution
hospital:

Enshi Central Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

胸部影像学

指标类型:

主要指标 

Outcome:

Chest imaging

Type:

Primary indicator 

测量时间点:

臭氧治疗前后

测量方法:

Measure time point of outcome:

Before and after ozone treatment

Measure method:

指标中文名:

新冠病毒核酸检测

指标类型:

主要指标 

Outcome:

RNA test of COVID-19

Type:

Primary indicator 

测量时间点:

臭氧治疗前后

测量方法:

Measure time point of outcome:

Before and after ozone treatment

Measure method:

指标中文名:

主要症状缓解/消失时间:定义为发热、咳嗽、气短三项主要症状全部缓解/全部消失的天数

指标类型:

主要指标 

Outcome:

Time to remission/disappearance of primary symptoms: defined as the number of days when the three main symptoms of fever, cough, and shortness of breath are all relieved / disappeared

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

完全退热时间:完全退热定义为体温恢复正常后24小时内无再升高。

指标类型:

主要指标 

Outcome:

Completely antipyretic time: completely antipyretic was defined as the body temperature return to normal for over 24 hours.

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

重型转化病例数:定义为纳入研究并开始干预后发生重型病例数

指标类型:

次要指标 

Outcome:

Conversion of severe cases: defined as the number of severe and critical cases that occurred after the study was included and the intervention was initiated

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院期间医疗并发症的发生率:定义为因新型冠状病毒感染的肺炎隔离住院期间发生医疗并发症的情况,包括合并细菌感染、基础疾病加重等

指标类型:

次要指标 

Outcome:

Incidence of medical complications during hospitalization: defined as medical complications during pneumonia isolation hospitalization due to novel coronavirus infection, including combined bacterial infections, exacerbation of underlying diseases, etc.

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指氧饱和度

指标类型:

主要指标 

Outcome:

Blood oxygen saturation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病毒核算转阴时间:定义为连续两次呼吸道病原核酸检测阴性(采样时间间隔至少1天)的末次检测时间

指标类型:

主要指标 

Outcome:

Time to 2019-nCoV RT-PCR negativity: defined as the last test time for two consecutive negative respiratory viral nucleic acid tests (sampling interval of at least 1 day)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

次要指标 

Outcome:

Routine blood test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

次要指标 

Outcome:

C-reactive protein

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血气分析

指标类型:

次要指标 

Outcome:

Blood gas analysis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝、肾、心脏功能

指标类型:

主要指标 

Outcome:

Liver, renal and heart function

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:

呼吸道分泌物

组织:

Sample Name:

Respiratory secretions

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):

随机平行试验 黄慧玲医师:请说明何人使用何种方法(统计学软件?随机数字表?或其他)产生随机序列?

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

Randomized parallel trial

盲法:

未说明

Blinding:

Not stated

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 shared public platform is 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, CRF 2.电子采集和管理系统, EDC

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, EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-23
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