Today is 2020-07-15

A multicenter, randomized controlled trial for the efficacy and safety of Alpha lipoic acid (iv) in the treatment of patients of severe novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000029851 

最近更新日期:

Date of Last Refreshed on:

2020-02-24 

注册时间:

Date of Registration:

2020-02-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

硫辛酸注射液在新型冠状病毒肺炎(COVID-19)重型及危重型患者中的有效性及安全性的多中心、随机对照临床研究 

Public title:

A multicenter, randomized controlled trial for the efficacy and safety of Alpha lipoic acid (iv) in the treatment of patients of severe novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

硫辛酸注射液在新型冠状病毒肺炎(COVID-19)重型及危重型患者中的有效性及安全性的多中心、随机对照临床研究 

Scientific title:

A multicenter, randomized controlled trial for the efficacy and safety of Alpha lipoic acid (iv) in the treatment of patients of severe 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:

徐磊 

研究负责人:

葛均波 

Applicant:

Lei Xu 

Study leader:

Junbo Ge 

申请注册联系人电话:

Applicant telephone:

+86 13917731869 

研究负责人电话:

Study leader's telephone:

+86-21-64041990 

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:

xu.lei2@zs-hospital.sh.cn 

研究负责人电子邮件:

Study leader's E-mail:

jbge@zs-hospital.sh.cn 

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:

上海市徐汇区枫林路180号 

研究负责人通讯地址:

上海市徐汇区枫林路180号 

Applicant address:

180 Fenglin Road, Xuhui District, Shanghai, China 

Study leader's address:

180 Fenglin Road, Xuhui District, Shanghai, 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:

复旦大学附属中山医院 

Applicant's institution:

Zhongshan Hospital, Fudan 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:

B2020-030 

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:

复旦大学附属中山医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Zhongshan Hospital, Fudan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-17 

伦理委员会联系人:

杨梦婕 

Contact Name of the ethic committee:

Mengjie Yang 

伦理委员会联系地址:

上海市徐汇区枫林路180号 

Contact Address of the ethic committee:

180 Fenglin Road, Xuhui District, Shanghai, 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:

复旦大学附属中山医院 

Primary sponsor:

Zhongshan Hospital, Fudan University 

研究实施负责(组长)单位地址:

上海市徐汇区枫林路180号 

Primary sponsor's address:

180 Fenglin Road, Xuhui District, Shanghai, 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):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属中山医院

具体地址:

徐汇区枫林路180号

Institution
hospital:

Zhongshan Hospital, Fudan University

Address:

180 Fenglin Road, Xuhui District

经费或物资来源:

复旦大学 

Source(s) of funding:

Fudan University 

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:

评估硫辛酸注射液治疗重型及危重型新型冠状病毒肺炎患者的有效性和安全性  

Objectives of Study:

To evaluate the clinical efficacy and safety of Alpha lipoic acid (ALA) for severe patients with 2019 novel coronavirus pneumonia (COVID-19) through randomized controlled trials during the current epidemic of NCP. 

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) 确诊新型冠状病毒肺炎的重症患者及危重症患者; (2) 35岁≤年龄<75岁 (3) 患者及家属自愿参与本项研究并签署知情同意书。 注:病例定义:重症NCP:参考国家卫健委制定《新型冠状病毒肺炎诊疗方案(第五版)》。 

Inclusion criteria

1. Severe patients diagnosed with novel coronavirus pneumonia (COVID-19); 2. Aged 35 years old to 74 years old; 3. Patients or authorized family members volunteered to participate in this study and signed informed consent. Note: Case definition: Severe NCP: Refer to the "New Coronavirus Pneumonia Diagnosis and Treatment Plan (Fifth Edition)" formulated by the National Health Commission. 

排除标准:

(1) 正在参加其他药物临床试验患者; (2) 孕妇或哺乳期的女性; (3) 存在其他可能威胁生命的严重疾病,如癌症; (4) 预期生存期<24小时; (5) 对硫辛酸或相似药物(B族维生素类)过敏患者,既往应用硫辛酸推荐剂量不耐受患者; (6) 有免疫系统疾病或与免疫系统密切相关的疾病史。 

Exclusion criteria:

1. Involving in other drug clinical trial; 2. Pregnant or breastfeeding; 3. Presence of other serious diseases that may be life threatening, such as cancer; 4. Expected life is less than 24 hours; 5. Allergy to ALA or drugs of similar chemical classes (Vitamin B),previous history of intolerance to recommended target doses of alpha-LA; 6. diagnosed with diseases of immune system. 

研究实施时间:

Study execute time:

From2020-02-19To 2020-03-10 

干预措施:

Interventions:

组别:

对照组

样本量:

34

Group:

control group

Sample size:

干预措施:

常规治疗+安慰剂

干预措施代码:

Intervention:

conventional therapy and placebo

Intervention code:

组别:

实验组

样本量:

34

Group:

Experience group

Sample size:

干预措施:

常规治疗+硫辛酸

干预措施代码:

Intervention:

conventional therapy and ALA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北省 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市金银潭医院 

单位级别:

三级甲等专科医院 

Institution
hospital:

Wuhan Jinyintan Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉大学人民医院 

单位级别:

三甲医院 

Institution
hospital:

Renmin's Hospital of Wuhan University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

华中科技大学附属同济医院 

单位级别:

三甲医院 

Institution
hospital:

Tongji Hospital Affiliated to Huazhong University of science and technology  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

序贯器官衰竭估计评分(SOFA

指标类型:

主要指标 

Outcome:

SOFA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治愈率

指标类型:

次要指标 

Outcome:

cure 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:

全因死亡率

指标类型:

次要指标 

Outcome:

All-cause mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

重症率

指标类型:

次要指标 

Outcome:

Severity rate

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:

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 35 years
最大 Max age 74 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):

采用SAS软件的proc plan过程,生成随机数字,并随机分为两组,分别为试验组和对照组。筛选合格受试者按照进入研究中心的时间先后顺序,以1:1的比例随机分配到试验组和对照组。

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

The procplan program of SAS software was used to generate random numbers and randomly them divided into two groups, namely the experimental group and the control group. Qualified subjects were randomly assigned to the experimental group and the control group at a 1: 1 ratio.

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):

论文发表

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

Publication of papers

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:

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-15
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