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氢氧气雾化机用于改善2019新型冠状病毒(COVID-19)肺炎患者症状的多中心、随机、平行对照临床研究
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注册号:

Registration number:

ChiCTR2000029739 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

氢氧气雾化机用于改善2019新型冠状病毒(COVID-19)肺炎患者症状的多中心、随机、平行对照临床研究 

Public title:

A Multicenter, Randomized, Parallel Controlled Clinical Study of Hydrogen-Oxygen Nebulizer to Improve the Symptoms of Patients 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:

氢氧气雾化机用于改善2019新型冠状病毒(COVID-19)肺炎患者症状的多中心、随机、平行对照临床研究 

Scientific title:

A Multicenter, Randomized, Parallel Controlled Clinical Study of Hydrogen-Oxygen Nebulizer to Improve the Symptoms of Patients 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:

 

申请注册联系人:

赵常胜 

研究负责人:

钟南山,郑则广 

Applicant:

Changsheng Zhao 

Study leader:

Nanshan Zhong, Zeguang Zheng 

申请注册联系人电话:

Applicant telephone:

+86 13916574201 

研究负责人电话:

Study leader's telephone:

+86 18928868242 

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:

cs.zhao@ascleway.com 

研究负责人电子邮件:

Study leader's E-mail:

zheng862080@139.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:

上海市嘉定区嘉新公路758号 

研究负责人通讯地址:

广州市越秀区沿江路151号 

Applicant address:

758 Jiaxin Road, Jiading District, Shanghai, China 

Study leader's address:

151 Yanjing Road, Yuexiu District, Guangzhou, China 

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:

上海潓美医疗科技有限公司 

Applicant's institution:

Shanghai Asclepius Meditec Co., Ltd. 

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:

医研伦审2020第29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:

广州医科大学附属第一医院医学伦理委员会 

Name of the ethic committee:

Ethic Committee of the First Affiliated Hospital of Guangzhou Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-10 

伦理委员会联系人:

余达加 

Contact Name of the ethic committee:

Dajia Yu 

伦理委员会联系地址:

广州市越秀区沿江路151号 

Contact Address of the ethic committee:

151 Yanjing Road, Yuexiu District, Guangzhou, 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:

广州医科大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Guangzhou Medical University 

研究实施负责(组长)单位地址:

广州市越秀区沿江路151号 

Primary sponsor's address:

151 Yanjing Road, Yuexiu District, Guangzhou, 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):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州医科大学附属第一医院

具体地址:

越秀区沿江路151号

Institution
hospital:

The First Affiliated Hospital of Guangzhou Medical University

Address:

151 Yanjing Road, Yuexiu District

经费或物资来源:

上海潓美医疗科技有限公司 

Source(s) of funding:

Shanghai Asclepius Meditec Co.,Ltd. 

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:

本研究为一项多中心、随机、平行对照临床研究,旨在评价上海潓美医疗科技有限公司生产的氢氧气雾化机用于辅助治疗2019-nCoV感染患者的有效性和安全性。 

Objectives of Study:

This study is a multi-center, randomized, parallel-controlled clinical study designed to evaluate the effectiveness and safety of the Hydrogen-Oxygen Nebulizer produced by Shanghai Asclepius Meditec Co.,Ltd. for adjuvant treatment of 2019-nCoV infection patients. 

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:

参与本临床研究的受试者必须符合以下所有的标准: 1) 符合《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》诊断标准的普通-重型之间的住院患者,即在满足普通型诊断标准的前提下再满足以下三个条件之一: a) 呼吸频率(RR):20-30 次/分; b) 吸空气静息状态下,外周氧饱和度:93-95%; c) 动脉血氧分压(PaO2)/吸氧浓度(FiO2):300-400mmHg(1mmHg=0.133kPa)。 2) 年龄≥18岁且≤85岁,有正常自主判断能力的患者,性别不限,地区不限; 3) 自愿参加研究并签署知情同意书的患者。 

Inclusion criteria

Subjects participating in this clinical study must meet all of the following criteria: 1. General- severe hospitalized patients who meet the diagnostic criteria of the "New Coronavirus Infected Pneumonia Diagnosis and Treatment Plan (Trial Version 5)". That is, one of the following three conditions is met on the premise that the general diagnostic criteria are met: 1) Respiratory frequency (RR): 20-30 times / minute; 2) Peripheral oxygen saturation: 93-95%; 3) Arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2): 300-400mmHg (1mmHg = 0.133kPa). 2. Patients aged >= 18 and <= 85 years, with normal autonomous judgment ability, regardless of gender and region; 3. Patients who voluntarily participated in the study and signed informed consent. 

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妊娠的女性。 3) 有以下呼吸系统疾病之一: a) 哮喘:基于研究者的判断,受试者目前诊断有哮喘。 b) 既往有COPD病史长期用药或影像学显示明显肺部结构破坏(例如,巨大肺大泡)的受试者。 c) 其他呼吸疾病:患有其他活动性肺部疾病的受试者,如活动性结核病、肺癌、湿性支气管扩张症(高分辨率CT显示支气管扩张症,每天有黄痰)、结节病、特发性间质性肺纤维化(IPF)、原发性肺动脉高压、未控制的睡眠呼吸暂停(即根据研究者的判断,疾病的严重程度会影响研究实施),合并气胸、胸腔积液、肺栓塞、支气管哮喘、肿瘤、不明原因发热等。 d) 肺减容:6 个月内接受过肺减容术、肺叶切除术、或经支气管镜肺减容术(支气管内封阻、气道旁路、支气管内瓣膜、蒸汽热消融、生物密封剂和气道植入剂)。 e) 处于病情危重或病情不稳定的患者。重症肺炎定义:①呼吸频率增快(≥30次/分),呼吸困难;②吸空气时外周血氧饱和度≤93%,或动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg;③肺部影像学显示多叶病变或48小时内病灶进展>50%;④合并气胸。 f) 肺炎风险因素:免疫抑制(HIV),影响上呼吸道控制的重度神经系统疾病,或研究者认为会致受试者处于显著肺炎风险的其他风险因素。 4) 合并心、肝、肾、造血系统等重要器官或系统严重原发性疾病。 5) 精神异常、认知障碍者。 6) 不依从:不依从研究步骤受试者,包括不依从完成日志。 7) 知情同意有效性有疑问:有精神病、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) 使用非祛痰抗氧化药物者,包括大剂量的维生素C,维生素E。 9) 研究者认为不适宜参加本研究者。 

Exclusion criteria:

1. Patients with a significant disease or condition other than the new coronavirus pneumonia, that is, a disease that, according to the investigator's judgment, may cause the subject to be at risk due to participation in the study, or affect the results of the study and the ability of the subject to participate in the study. 2. Women who are pregnant or nursing or plan to become pregnant during the study. 3. Have one of the following respiratory diseases: 1) Asthma: Based on the investigator's judgment, the subject is currently diagnosed with asthma. 2) Subjects with a previous history of COPD or long-term medication or imaging that showed significant lung structural damage (eg, giant pulmonary bullae). 3) Other respiratory diseases: subjects with other active lung diseases, such as active tuberculosis, lung cancer, wet bronchiectasis (high-resolution CT shows bronchiectasis, yellow sputum every day), sarcoidosis, idiopathic Interstitial Pulmonary Fibrosis (IPF), Primary Pulmonary Arterial Hypertension, Uncontrolled Sleep Apnea (ie, the severity of the disease will affect the implementation of the study at the investigator's discretion), combined with pneumothorax, pleural effusion and pulmonary embolism , Bronchial asthma, tumors, fever of unknown origin, etc. 4) Lung volume reduction: Lung volume reduction, lobectomy, or bronchoscopic lung volume reduction within 6 months (bronchial obstruction, airway bypass, bronchial valve, steam thermal ablation, biological sealant, Implants). 5) Patients who are critically ill or unstable. Definition of Severe Pneumonia: A. Increased breathing rate ( >= 30 beats / min), difficulty breathing; B. Peripheral blood oxygen saturation <= 93% when inhaling air, or arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <= 300mmHg; C. Lung imaging showed multi-leaf disease or lesion progression> 50% within 48 hours; D. Combined with pneumothorax. 6) Pneumonia risk factors: immunosuppression (HIV), severe neurological disease affecting upper respiratory tract control, or other risk factors that the investigator believes may put the subject at a significant risk of pneumonia. 4. Complicate serious primary diseases such as heart, liver, kidney, and hematopoietic system. 5. People with mental disorders and cognitive impairment. 6. Non-compliance: Subjects who did not comply with the study procedures, including non-compliance completion logs. 7. Questions about the effectiveness of informed consent: subjects with a history of psychosis, mental retardation, poor motivation, substance abuse (including drugs and alcohol), or other medical conditions that limit the effectiveness of informed consent in this study. 8. Those who use non-expectorant antioxidant drugs, including large doses of vitamin C and vitamin E. 9. Researchers consider it inappropriate to participate in this research. 

研究实施时间:

Study execute time:

From2020-02-01To 2021-08-31 

干预措施:

Interventions:

组别:

试验组

样本量:

220

Group:

Experimental group

Sample size:

干预措施:

氢氧气雾化机

干预措施代码:

Intervention:

Hydrogen-Oxygen Nebulizer

Intervention code:

组别:

对照组

样本量:

220

Group:

Control group

Sample size:

干预措施:

制氧机

干预措施代码:

Intervention:

Oxygen concentrator

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Guangzhou Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州市第八人民医院 

单位级别:

三级 

Institution
hospital:

Guangzhou Eighth People's Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市公共卫生临床中心 

单位级别:

三甲 

Institution
hospital:

Shanghai Public Health Clinical Center  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

病情恶化并发展成为重型或危重型

指标类型:

主要指标 

Outcome:

the condition worsens and develops into severe or critical condition

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病情明显好转并达到出院标准

指标类型:

主要指标 

Outcome:

the condition improves significantly and reaches the discharge standard

Type:

Primary indicator 

测量时间点:

测量方法:

参考《新型冠状病毒感染的肺炎治疗方案(试行第五版)》

Measure time point of outcome:

Measure method:

指标中文名:

整体治疗时间最长不超过14天

指标类型:

主要指标 

Outcome:

The overall treatment time is no longer than 14 days

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者入组到病情进展为重型或危重型的时间

指标类型:

次要指标 

Outcome:

The time from the patient's enrollment to the progression to severe or critical condition

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者入组到临床缓解时间:临床症状缓解定义为:患者体温正常>72小时(未服用退热药物或激素情况下)且无自觉无呼吸困难或呼吸困难减轻;

指标类型:

次要指标 

Outcome:

The time from patient enrollment to clinical remission: clinical symptom relief is defined as: the patient's body temperature is normal for > 72 hours (without taking antipyretic drugs or hormones) and there is no conscious dyspnea or dyspnea decreases

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疾病恢复时间(达到出院标准)

指标类型:

次要指标 

Outcome:

disease recovery time (up to discharge standard)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发热持续时间

指标类型:

次要指标 

Outcome:

duration of fever

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

入组后14天体温正常患者比例

指标类型:

次要指标 

Outcome:

Proportion of patients with normal body temperature within 14 days after enrollment

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸道症状评估,通过莱赛斯特咳嗽量表(Leicester cough questionnaire,LCQ)评估咳嗽情况

指标类型:

次要指标 

Outcome:

Evaluation of respiratory symptoms, coughing condition was assessed by Leicester Cough Questionnaire (LCQ)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

入组后14天无咳嗽患者比例

指标类型:

次要指标 

Outcome:

Proportion of patients without cough 14 days after enrollment

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

入组后14天无呼吸困难患者比例

指标类型:

次要指标 

Outcome:

Proportion of patients without dyspnea in 14 days after enrollment

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

实验室检查血常规、C反应蛋白、心肌酶、肝功能、肾功能、肌酶等

指标类型:

次要指标 

Outcome:

Laboratory examination of blood routine, C-reactive protein, myocardial enzymes, liver function, renal function, muscle enzymes, 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:

入组后第14天患者呼吸道标本新型冠状病毒核酸转阴率。

指标类型:

次要指标 

Outcome:

On the 14th day after enrollment, the negative rate of novel coronavirus nucleic acid in respiratory specimens of patients was negative.

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:

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:

鼻咽拭子

组织:

Sample Name:

Nasopharyngeal swabs

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:

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 85 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):

随机编码在 SAS 9.4 软件中使用随机区组法生成。

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

Random codes are generated in the SAS 9.4 software using the Block randomization method.

盲法:

Not stated

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:

即时公开/Real time access

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):

待所有文章发表后,通过数据库,提供原始数据查询。

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

After all articles are published, the original data query will be provided through the database.

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:

将由各研究中心接受过培训的工作人员采集所有数据。然后将数据填写在设计的病例报告表(CRF)中。研究者负责确保录入采集数据的完整、准确与及时记录。然后由项目组对病历中的数据进行审查。按照适用的标准和数据清理程序进行临床数据管理,以确保数据的完整性。

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

All data will be collected by staff trained in each research centre. The data is then filled in a designed case report form (CRF). The investigator is responsible for ensuring that the data entered is complete, accurate, and timely. The project team then reviews the data in the medical records. Manage clinical data in accordance with applicable standards and data cleaning procedures to ensure data integrity.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-02-11
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