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韩琳琳医师: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。 三氧大自血疗法对新型冠状病毒肺炎 (COVID-19)的治疗作用
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注册号:

Registration number:

ChiCTR2000030006 

最近更新日期:

Date of Last Refreshed on:

2020-02-19 

注册时间:

Date of Registration:

2020-02-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

韩琳琳医师: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。 三氧大自血疗法对新型冠状病毒肺炎 (COVID-19)的治疗作用 

Public title:

A randomized controlled trial for the efficacy of 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:

探讨三氧大自血疗法对2019新型冠状病毒肺炎 (COVID-19) 的治疗效果:一项单中心、单盲的随机临床对照研究 

Scientific title:

A randomized controlled trial for the efficacy of ozonated autohemotherapy in the treatment of Novel Coronavirus Pneumonia (COVID-19) 

研究课题代号(代码):

Study subject ID:

2018YFC2001802 

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:

韩琳琳 

研究负责人:

陈向东 

Applicant:

Han Linlin 

Study leader:

Chen Xiangdong 

申请注册联系人电话:

Applicant telephone:

+86 15871719285 

研究负责人电话:

Study leader's telephone:

+86 15071096621 

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:

790493073@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

xiangdongchen2013@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:

湖北省武汉市解放大道1277号 

研究负责人通讯地址:

湖北省武汉市解放大道1277号 

Applicant address:

1277 Jiefang Avenue, Wuhan, Hubei, China 

Study leader's address:

1277 Jiefang Avenue, Wuhan, Hubei, China 

申请注册联系人邮政编码:

Applicant postcode:

430000 

研究负责人邮政编码:

Study leader's postcode:

430000 

申请人所在单位:

华中科技大学同济医学院附属协和医院 

Applicant's institution:

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 

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:

华中科技大学同济医学院附属协和医院 

Primary sponsor:

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 

研究实施负责(组长)单位地址:

湖北省武汉市解放大道1277号 

Primary sponsor's address:

1277 Jiefang Avenue, Wuhan, Hubei, 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):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

华中科技大学同济医学院附属协和医院

具体地址:

解放大道1277号

Institution
hospital:

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address:

1277 Jiefang Avenue

经费或物资来源:

国家重点研发计划(2018YFC2001802) 

Source(s) of funding:

National Key Research and Development Project (2018YFC2001802) 

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:

其它 

Study phase:

N/A 

研究目的:

观察三氧大自血疗法治疗2019新型冠状病毒肺炎的治疗效果。 

Objectives of Study:

To observe the therapeutic effect of ozonated autohemotherapy in the treatment of 2019-nCoV 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) 符合伦理,签署书面知情同意书; (2) 新型冠状病毒核酸检测阳性患者; (3) 胸部CT证实肺部病变; (4) 伴有发热或呼吸道症状的住院患者; (5) 三个月内未参与其他临床研究患者。 

Inclusion criteria

(1) In line with ethics, sign a written informed consent form; (2) Patients with positive detection of new coronavirus nucleic acid; (3) Chest CT confirmed pulmonary lesions; (4) Hospitalized patients with fever or respiratory symptoms; (5) Patients who did not participate in other clinical studies within three months. 

排除标准:

(1) 甲亢; (2) 蚕豆病; (3) 怀孕; (4) 凝血功能异常,血小板减少症,活动性出血; (5) 医用臭氧过敏者或高敏体质者; (6) 严重贫血; (7) 低钙血症; (8) 严重心血管疾病不稳定期; (9) 未得到控制的糖尿病。 

Exclusion criteria:

(1) Hyperthyroidism; (2) Favism; (3) Pregnancy; (4) Abnormal coagulation, thrombocytopenia, active bleeding; (5) People with medical ozone allergy or hypersensitivity; (6) Severe anemia; (7) Hypocalcemia; (8) Unstable period of severe cardiovascular disease; (9) Uncontrolled diabetes. 

研究实施时间:

Study execute time:

From2020-02-19To 2020-05-19 

征募观察对象时间:

Recruiting time:

From2020-02-19To 2020-04-19 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

Experimental group

Sample size:

干预措施:

三氧大自血疗法

干预措施代码:

Intervention:

ozonated autohemotherapy

Intervention code:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

标准内科治疗

干预措施代码:

Intervention:

Standard medical treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

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):

华中科技大学同济医学院附属协和医院 

单位级别:

三级甲等 

Institution
hospital:

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

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:

退热时间

指标类型:

次要指标 

Outcome:

Antifebrile time

Type:<