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A multicenter, randomized, controlled trial for efficacy and safety of hydrogen inhalation in the treatment of novel coronavirus pneumonia (COVID-19) patients
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注册号:

Registration number:

ChiCTR2000030258 

最近更新日期:

Date of Last Refreshed on:

2020-02-26 

注册时间:

Date of Registration:

2020-02-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

氢气吸入治疗2019新型冠状病毒肺炎(COVID-19)患者有效性和安全性的多中心、随机、对照临床研究 

Public title:

A multicenter, randomized, controlled trial for efficacy and safety of hydrogen inhalation in the treatment of novel coronavirus pneumonia (COVID-19) patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

氢气吸入治疗2019新型冠状病毒肺炎(COVID-19)患者有效性和安全性的多中心、随机、对照临床研究 

Scientific title:

A multicenter, randomized, controlled trial for efficacy and safety of hydrogen inhalation in the treatment of novel coronavirus pneumonia (COVID-19) patients 

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:

杨巍 

研究负责人:

杨巍 

Applicant:

Wei Yang 

Study leader:

Wei Yang 

申请注册联系人电话:

Applicant telephone:

+86 13845099775 

研究负责人电话:

Study leader's telephone:

+86 13845099775 

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:

hydyangwei@tom.com 

研究负责人电子邮件:

Study leader's E-mail:

hydyangwei@tom.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:

中国黑龙江哈尔滨市南岗区颐园街37号 

研究负责人通讯地址:

中国黑龙江哈尔滨市南岗区颐园街37号 

Applicant address:

37 Yiyuan Street, Nangang District, Harbin, Heilongjiang, China 

Study leader's address:

37 Yiyuan Street, Nangang District, Harbin, Heilongjiang, China 

申请注册联系人邮政编码:

Applicant postcode:

150001 

研究负责人邮政编码:

Study leader's postcode:

150001 

申请人所在单位:

哈尔滨医科大学附属第四医院 

Applicant's institution:

The Fourth Affiliated Hospital of Harbin Medical 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-HYDSYLL-02 

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:

哈尔滨医科大学附属第四医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of the Fourth Affiliated Hospital of Harbin Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-20 

伦理委员会联系人:

王玉珏 

Contact Name of the ethic committee:

Yujue Wang 

伦理委员会联系地址:

哈尔滨市南岗区颐园街37号 

Contact Address of the ethic committee:

37 Yiyuan Street, Nangang District, Harbin, Heilongjiang, 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:

哈尔滨医科大学附属第四医院 

Primary sponsor:

The Fourth Affiliated Hospital of Harbin Medical University 

研究实施负责(组长)单位地址:

哈尔滨市南岗区颐园街37号 

Primary sponsor's address:

37 Yiyuan street, Nangang District, Harbin, Heilongjiang, 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):

黑龙江省

市(区县):

Country:

China

Province:

Heilongjiang

City:

单位(医院):

哈尔滨医科大学附属第四医院

具体地址:

哈尔滨市南岗区颐园街37号

Institution
hospital:

The fourth Affiliated Hospital of Harbin Medical University, Harbin

Address:

37 Yiyuan street, Nangang District, Harbin

经费或物资来源:

“上海纳诺巴伯纳米科技有限公司”提供氢气机 

Source(s) of funding:

Hydrogen machines supplied by Shanghai nano technology company 

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:

治疗研究 

Study type:

Treatment study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

课题组开展氢气吸入治疗2019新型冠状病毒肺炎(COVID-19)患者项目,评价氢气吸入治疗COVID-19住院患者的的安全性、有效性。 

Objectives of Study:

The Coronavirus Disease 2019 (COVID-19) project was evaluated by the hydrogen inhalation therapy,and the safety and efficacy of hydrogen inhalation therapy in COVID-19 patients were evaluated. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

(1)成人(定义为年龄≥18 岁)理解并同意签署知情同意书; (2)经过实验室RT-PCR 确诊的新型冠状病毒感染患者; (3)住院患者,伴有发热(腋温≥37.0°C)或呼吸道症状; (4)症状发作与随即入组之间的时间间隔在14天以内; (5) 3 个月内未参加其他临床试验者; (6)随访的14天内不再参与其他抗病毒药物研究。 

Inclusion criteria

(1) Adults aged >=18 years understand and agree to sign informed consent; (2) a novel coronavirus infection confirmed by laboratory RT-PCR. (3) Hospitalized patients with fever (axillary temperature >=37.0 degree C) or respiratory symptoms; (4) The interval between symptom onset and immediate enrollment is within 14 days; (5) Those who did not participate in other clinical trials within 3 months; (6) No other antiviral drugs were involved in the follow-up study within 14 days. 

排除标准:

(1) 患有新型冠状病毒肺炎以外的显著疾病或状况,即根据研究者的判断,会导致受试者因参与研究而处于风险,或对研究结果和受试者参加本研究的能力有影响的疾病。 (2) 正在妊娠或哺乳或者计划在研究期间内妊娠的女性。 (3) 合并心、肝、肾、造血系统等重要器官或系统严重原发性疾病。 (4) 重度及危重患者:呼吸窘迫,RR≥30次/分;静息状态下,指氧饱和度≤93%;动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg;出现呼吸衰竭,且需要机械通气;出现休克;合并其他器官功能衰竭需ICU监护治疗。 (5) 年龄≥70岁患者。 (6) 精神异常、认知障碍患者。 (7) 在院期间依从性差者、不愿参与项目者或不签署知情同意书者。知情同意有效性有疑问:有精神疾病、智力发育不全、动机不良、药物滥用(包括药物和酒精)或其他限制参加本研究知情同意有效性的疾病史的受试者。 (8) 应用糖皮质激素患者。 (9) 研究者认为不适宜参加本研究患者。 

Exclusion criteria:

(1) novel coronavirus pneumonia is a disease or condition beyond the pneumonia. That is, according to the researchers' judgement, the subjects will be at risk for taking part in the research, or will have an impact on the results of the study and the ability of the subjects to participate in the study; (2) A woman who is pregnant or breastfeeding or who plans to be pregnant during the study period; (3) Combined with heart, liver, kidney, hematopoietic system and other important organs or systems of serious primary diseases; (4) Severe and critical patients: respiratory distress, RR >=30 times / min; in resting state, oxygen saturation <= 93%; arterial partial pressure of oxygen (PaO2) / concentration of oxygen (FiO2) < 300MMHG; respiratory failure, mechanical ventilation; shock; other organ failure requiring ICU monitoring and treatment; (5) Patients over 70 years old; (6) Patients with mental disorders and cognitive disorders; (7) Those who have poor compliance, are unwilling to participate in the project or do not sign the informed consent during their stay in the hospital. There are doubts about the validity of informed consent: subjects with mental illness, mental retardation, poor motivation, drug abuse (including drugs and alcohol) or other disease history restricting the validity of informed consent in this study; (8) Patients with glucocorticoid; (9) The researchers think it is not suitable to participate in this study. 

研究实施时间:

Study execute time:

From2020-02-21To 2020-08-20 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

Experimental group

Sample size:

干预措施:

常规药物治疗加氢气吸入

干预措施代码:

Intervention:

Conventional drug therapy plus hydrogen inhalation

Intervention code:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

常规药物治疗

干预措施代码:

Intervention:

Conventional drug therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

黑龙江省 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

哈尔滨医科大学附属第四医院 

单位级别:

三甲医院 

Institution
hospital:

The fourth Affiliated Hospital of Harbin Medical University, Harbin  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江省 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

哈尔滨市传染病医院 

单位级别:

三甲医院 

Institution
hospital:

Harbin infectious diseases hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江省 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

哈尔滨市胸科医院 

单位级别:

三甲医院 

Institution
hospital:

Harbin Chest Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江省 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

黑龙江省传染病防治院 

单位级别:

三甲医院 

Institution
hospital:

Heilongjiang Provincial Institute of infectious diseases  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

体温

指标类型:

主要指标 

Outcome:

temperature

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸频率

指标类型:

主要指标 

Outcome:

respiratory 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:

血氧饱和度

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:

咳嗽症状

指标类型:

主要指标 

Outcome:

Cough symptom

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺CT

指标类型:

主要指标 

Outcome:

Lung 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:

退热时间

指标类型:

次要指标 

Outcome:

Antipyretic time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部ct 炎症吸收程度

指标类型:

次要指标 

Outcome:

Pulmonary CT inflammatory absorption

Type:

Secondary 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:

次要指标 

Outcome:

Time of nucleic acid turning negative

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病死率

指标类型:

主要指标 

Outcome:

Fatality 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:

Severe conversion rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量

指标类型:

次要指标 

Outcome:

quality of life

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

焦虑情况

指标类型:

次要指标 

Outcome:

anxiety

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁情况

指标类型:

次要指标 

Outcome:

depression

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

工具性日常生活活动能力

指标类型:

次要指标 

Outcome:

IADL

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基础性日常生活活动能力

指标类型:

次要指标 

Outcome:

basic ADL

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

6分钟步行试验

指标类型:

附加指标 

Outcome:

6-minute walk test

Type:

Additional 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:

尿液

组织:

Sample Name:

urine

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 70 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):

将病人的年龄、性别和病情程度进行分层后,再按照就诊顺序采用随机数字表进行分组。

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

Patients were stratified by their age、gender and severity of disease, and then grouped by a random number table in the order of their visits.

盲法:

Open label

Blinding:

Open label

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):

论文支持材料

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

surpporting materials for the artical

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:

 2020-02-26
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