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Cancelled by the investigator Clinical application of inhaled acetylcysteine solution in the treatment of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030328 

最近更新日期:

Date of Last Refreshed on:

2020-04-10 

注册时间:

Date of Registration:

2020-02-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

研究者要求撤消 吸入用乙酰半胱氨酸溶液治疗新型冠状病毒肺炎(COVID-19)临床应用研究 

Public title:

Cancelled by the investigator Clinical application of inhaled acetylcysteine solution 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:

吸入用乙酰半胱氨酸溶液治疗新型冠状病毒肺炎(COVID-19)临床应用研究 

Scientific title:

Clinical application of inhaled acetylcysteine solution 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:

孙树俊 

研究负责人:

林云 

Applicant:

ShuJun Sun 

Study leader:

Yun Lin 

申请注册联系人电话:

Applicant telephone:

+86 15804066597 

研究负责人电话:

Study leader's telephone:

+86 13986268403 

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:

486481637@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

frank0130@126.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:

湖北省武汉市江汉区解放大道1277号 

研究负责人通讯地址:

湖北省武汉市江汉区解放大道1277号 

Applicant address:

1277 Jiefang Road, Jianghan District, Wuhan, Hubei, China  

Study leader's address:

1277 Jiefang Road, Jianghan District, Wuhan, Hubei, 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:

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 & 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 & Technology  

研究实施负责(组长)单位地址:

湖北省武汉市江汉区解放大道1277号 

Primary sponsor's address:

1277 Jiefang Road, Jianghan District, 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:

江汉区解放大道1277号

Institution
hospital:

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

Address:

1277 Jiefang Road, Jianghan District

经费或物资来源:

无 

Source(s) of funding:

NO 

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:

上市后药物 

Study phase:

研究目的:

评价吸入用乙酰半胱氨酸溶液对新型冠状病毒肺炎的疗效。  

Objectives of Study:

To evaluate the effect of inhaled acetylcysteine solution on 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:

连续入组 

Study design:

Sequential 

纳入标准:

(1) 符合《新型冠状病毒感染的肺炎诊疗方案(试行第六版)》(以下简称《方案》)中COVID-19诊断标准; (2) 年龄≥18岁且接受气管插管患者; (3) 同意参加研究,患者本人、法定监护人或医疗机构负责人通过纸质签署、手机软件电子签署、语音授权签署知情同意书。  

Inclusion criteria

(1) Comply with the diagnostic criteria for general type COVID-19 in the "Diagnosis and Treatment Program for COVID-19"(trial version 6th); (2) Patients ≥18 years of age with tracheal intubation; (3) Agree to participate in the trial, and the patient, the legal guardian or the person in charge of the medical institution signed the informed consent through paper signature, electronic signature of mobile phone software, or voice authorization.  

排除标准:

1.影响生存的严重基础疾病,包括:未控制已经多处转移不能切除的恶性肿瘤、血液病、恶液质、活动性出血、严重营养不良、艾滋病等。 2.肺部肿瘤致阻塞性肺炎、严重肺间质纤维化、肺泡蛋白沉积症、过敏性肺泡炎者。 3.使用体外生命支持者(ECMO、 ECCO2R)。 4.支气管哮喘、消化道溃疡和对乙酰半胱氨酸过敏的患者。 5.可能存在的潜在的违背试验依从性或者影响安全性和有效性评价的其他任何情况,研究者认为不适合参加研究的患者。 

Exclusion criteria:

1.Serious basic diseases affecting survival, including: uncontrolled malignant tumor with multiple metastases that cannot be removed, hematological diseases, cachexia, active hemorrhage, severe malnutrition, AIDS, etc.; 2.Obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis and allergic alveolitis caused by lung tumor; 3.Use in vitro life support (ECMO, ECCO2R); 4.Patients with bronchial asthma, peptic ulcer, and patients allergic to acetylcysteine; 5.Any potential violation of test compliance or any other circumstance affecting safety and effectiveness evaluation that may exist, which the researchers believe is not suitable for patients participating in the study.  

研究实施时间:

Study execute time:

From2020-02-28To  

征募观察对象时间:

Recruiting time:

From2020-03-02To  

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

Experimental group

Sample size:

干预措施:

乙酰半胱氨酸经气管导管吸入给药

干预措施代码:

Intervention:

Acetylcysteine inhaled via tracheal tube

Intervention code:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

安慰剂(生理盐水)经气管导管吸入给药

干预措施代码:

Intervention:

Placebo (saline) inhaled via tracheal tube

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:

三甲医院 

Institution
hospital:

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

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

3天后肺部CT

指标类型:

主要指标 

Outcome:

Lung CT after 3 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:

7天后肺部CT

指标类型:

主要指标 

Outcome:

Lung CT after 7 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:

氧合指标:血氧饱和度,动脉氧分压,氧合指数

指标类型:

主要指标 

Outcome:

Oxygenation parameters: SpO2, Partial arterial oxygen pressure (PaO2), PaO2/FiO2

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

主要指标 

Outcome:

Hospital stay

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新型冠状病毒核酸检测

指标类型:

主要指标 

Outcome:

Novel coronavirus nucleic acid detection

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

吸痰量

指标类型:

次要指标 

Outcome:

Sputum suction amount

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

循环指标:血压、心率

指标类型:

次要指标 

Outcome:

Circulation indicators: blood pressure, heart 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:

复发率

指标类型:

主要指标 

Outcome:

Recurrence rate

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:

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 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):

由与本试验执行数据管理统计分析无关的生物统计学家,在计算机上用SAS统计软件包,按试验组与对照组1:1的比例中心分层随机化方法产生随机编码,按规定保存盲底。

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

A biostatistician who has no relationship with the statistical analysis of data management in this experiment, using a SAS statistical software package on a computer, a random coding method was used to generate random coding according to a 1: 1 example of the experimental group and the control group, an

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):

是否共享原始数据:

IPD sharing

Yes

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):

中国临床试验中心等网络平台,时间为试验结束半年内

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

China clinical trial center and other network platforms, within half a year after the end of the trial

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:

通过病例记录表采集记录数据,建立电子数据库管理数据。

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

Collect record data through case record table and establish electronic database management data.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-28
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