今天是:2020-10-31 星期六

硫辛酸注射液降低新型冠状病毒肺炎(COVID-19)普通型患者进展风险的有效性及安全性的前瞻性、多中心、单盲、随机对照临床研究
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注册号:

Registration number:

ChiCTR2000030471 

最近更新日期:

Date of Last Refreshed on:

2020-03-08 

注册时间:

Date of Registration:

2020-03-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

硫辛酸注射液降低新型冠状病毒肺炎(COVID-19)普通型患者进展风险的有效性及安全性的前瞻性、多中心、单盲、随机对照临床研究 

Public title:

Efficacy and safety of lipoic acid injection in reducing the risk of progression in common 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:

硫辛酸注射液降低新型冠状病毒肺炎(COVID-19)普通型患者进展风险的有效性及安全性的前瞻性、多中心、单盲、随机对照临床研究 

Scientific title:

Efficacy and safety of lipoic acid injection in reducing the risk of progression in common 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:

胡林辉 

研究负责人:

陈纯波 

Applicant:

Hu Linhui 

Study leader:

Chen Chunbo 

申请注册联系人电话:

Applicant telephone:

+86 13580013426 

研究负责人电话:

Study leader's telephone:

+86 13922745788 

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:

hulinhui@live.cn 

研究负责人电子邮件:

Study leader's E-mail:

gghicu@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:

广东省茂名市为民路101号 

研究负责人通讯地址:

广东省茂名市为民路101号 

Applicant address:

101 Weimin Road, Maoming, Guangdong, China 

Study leader's address:

101 Weimin Road, Maoming, Guangdong, 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:

茂名市人民医院 

Applicant's institution:

Maoming People's Hospital 

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:

2020013 

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:

茂名市人民医院伦理委员会 

Name of the ethic committee:

Ethic Committee of Maoming People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-02 

伦理委员会联系人:

黄文东 

Contact Name of the ethic committee:

Huang Wendong 

伦理委员会联系地址:

广东省茂名市为民路101号 

Contact Address of the ethic committee:

101 Weimin Road, Maoming, Guangdong, 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:

茂名市人民医院 

Primary sponsor:

Maoming People's Hospital 

研究实施负责(组长)单位地址:

广东省茂名市为民路101号 

Primary sponsor's address:

101 Weimin Road, Maoming, Guangdong, 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):

广东省

市(区县):

Country:

China

Province:

Guangdong

City:

Maoming

单位(医院):

茂名市人民医院

具体地址:

广东省茂名市为民路101号

Institution
hospital:

Maoming People's Hospital

Address:

101 Weimin Road, Maoming, Guangdong

经费或物资来源:

自筹 

Source(s) of funding:

Self-funded 

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:

评估硫辛酸注射液降低普通型COVID-19进展风险的有效性和安全性 

Objectives of Study:

Evaluation of the efficacy and safety of lipoic acid injection in reducing the risk of progression in common patients with 2019 novel coronavirus disease (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:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)18岁≤年龄≤75岁; (2)已确诊COVID-19的普通型患者,具体按照国卫健委发布的《新型冠状病毒感染诊疗方案(试行第六版)》诊断标准; (3)患者及家属自愿参与本项研究并签署知情同意书。 

Inclusion criteria

(1) Patients aged from 18 to 75 years old; (2) Mild patients with confirmed COVID-19 according to the diagnostic criteria of "novel coronavirus Infection Diagnosis and Treatment Plan (Trial 6th Edition)" issued by the National Health and Safety Commission; (3) Patients and their families voluntarily participated in the study and signed an informed consent form. 

排除标准:

(1)处于妊娠期或哺乳期的女性患者; (2)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; (3)正在参加其他药物临床试验患者; (4)患者正在服用其它具有抗氧化作用的食品或药品,如维生素C、维生素E等; (5)存在其他可能威胁生命的严重疾病,如癌症。 

Exclusion criteria:

(1) Female patients during pregnancy or lactation; (2) Patients allergic to lipoic acid or similar drugs (B vitamins), previously intolerant to the recommended dose of lipoic acid; (3) Patients who are taking part in clinical trials of other drugs; (4) Patients are taking other foods or drugs with antioxidant effect, such as vitamin C, vitamin E, etc. (5) Patients with other serious diseases that may threaten life, such as cancer. 

研究实施时间:

Study execute time:

From2020-03-02To 2020-04-30 

征募观察对象时间:

Recruiting time:

From2020-03-02To 2020-05-30 

干预措施:

Interventions:

组别:

硫辛酸组

样本量:

197

Group:

Lipoic acid group

Sample size:

干预措施:

常规治疗联合硫辛酸注射液

干预措施代码:

01

Intervention:

Routine Therapy and administration of Lipoic acid injection

Intervention code:

组别:

空白对照组

样本量:

197

Group:

Blank control group

Sample size:

干预措施:

常规治疗联合安慰剂

干预措施代码:

02

Intervention:

Routine Therapy and administration of placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

茂名市 

Country:

China 

Province:

Guangdong 

City:

Maoming 

单位(医院):

茂名市人民医院 

单位级别:

三级甲等 

Institution
hospital:

Maoming People's Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广东省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Guangdong Provincial People's Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

武汉市 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市汉口医院 

单位级别:

三级综合 

Institution
hospital:

Wuhan City Hankou Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

荆州市 

Country:

China 

Province:

Hubei 

City:

Jingzhou 

单位(医院):

荆州市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Jingzhou Central Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

惠州市 

Country:

China 

Province:

Guangdong 

City:

Huizhou 

单位(医院):

惠州市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Huizhou Central Hospital  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

普通型患者进展为重症、危重症的比例

指标类型:

主要指标 

Outcome:

Progression rate from mild to critical/severe

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NEWS评分

指标类型:

次要指标 

Outcome:

NEW Score

Type:

Secondary 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:

次要指标 

Outcome:

Hospital Stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

30天全因死亡率

指标类型:

次要指标 

Outcome:

30-day 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:

炎症因子与氧化应激标记物水平

指标类型:

次要指标 

Outcome:

Levels of Inflammatory Factors and Oxidative Stress Markersive Stress Markers

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 18 years
最大 Max age 75 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):

入选的患者被随机化中心通过电话验证按照1:1的比例随机分配到每家医院,每个区组中有4名患者接受药物治疗(硫辛酸组),另外4名患者作为对照(安慰剂组)。向研究者隐藏患者分配顺序。为防止提前知晓治疗分配和破坏分配顺序,在揭开唯一的参与号码与分配组别前,填写病例报告表(CRF)中的试验输入表,并签署知情同意书,此后不得更改和删除此唯一号码。

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

Recruited patients were randomly assigned to each hospital by telephone verification in a ratio of 1:1. Four patients in each district group received drug therapy (lipoic acid group) and another four patients served as controls (placebo group). Hide patient assignment order from researchers.

盲法:

单盲

Blinding:

Single blind

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):

2020年5月

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

Till May 2020

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 From

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-02
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