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A randomized, open, controlled trial for diammonium glycyrrhizinate enteric-coated capsules combined with vitamin C tablets in the treatment of common novel coronavirus pneumonia (COVID-19) in the basic of clinical standard antiviral treatment to evaluate the safety and efficiency
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注册号:

Registration number:

ChiCTR2000029768 

最近更新日期:

Date of Last Refreshed on:

2020-02-13 

注册时间:

Date of Registration:

2020-02-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

评价甘草酸二铵肠溶胶囊联合维生素C片在临床标准抗病毒治疗基础上治疗普通型新型冠状病毒肺炎 (COVID-19)的有效性和安全性的随机、开放、平行对照临床研究 

Public title:

A randomized, open, controlled trial for diammonium glycyrrhizinate enteric-coated capsules combined with vitamin C tablets in the treatment of common novel coronavirus pneumonia (COVID-19) in the basic of clinical standard antiviral treatment to evaluate the safety and efficiency 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价甘草酸二铵肠溶胶囊联合维生素C片在临床标准抗病毒治疗基础上治疗普通型新型冠状病毒肺炎 (COVID-19)的有效性和安全性的随机、开放、平行对照临床研究 

Scientific title:

A randomized, open, controlled trial for diammonium glycyrrhizinate enteric-coated capsules combined with vitamin C tablets in the treatment of common novel coronavirus pneumonia (COVID-19) in the basic of clinical standard antiviral treatment to evaluate the safety and efficiency 

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:

林军 

研究负责人:

林军 

Applicant:

Jun Lin 

Study leader:

Jun Lin 

申请注册联系人电话:

Applicant telephone:

+86 13971156723 

研究负责人电话:

Study leader's telephone:

+86 13971156723 

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:

wdznyy@126.com 

研究负责人电子邮件:

Study leader's E-mail:

wdznyy@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:

武汉市武昌区东湖路169号 

研究负责人通讯地址:

武汉市武昌区东湖路169号 

Applicant address:

169 Donghu Road, Wuchang District, Wuhan, Hubei  

Study leader's address:

169 Donghu Road, Wuchang District, Wuhan, Hubei  

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:

武汉大学中南医院 

Applicant's institution:

Zhongnan Hospital of Wuhan 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:

临研伦[2020016] 

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:

武汉大学中南医院伦理委员会 

Name of the ethic committee:

The Ethics Committee of Zhongnan Hospital of Wuhan University  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-12 

伦理委员会联系人:

郑磊(武汉大学中南医院伦理委员会秘书) 

Contact Name of the ethic committee:

Zheng Lei 

伦理委员会联系地址:

湖北省武汉市武昌区东湖路169号 

Contact Address of the ethic committee:

169 Donghu Road, Wuchang District, Wuhan, Hubei, 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:

武汉大学中南医院 

Primary sponsor:

Zhongnan Hospital of Wuhan University 

研究实施负责(组长)单位地址:

武汉市武昌区东湖路169号 

Primary sponsor's address:

169 Donghu Road, Wuchang District, Wuhan, Hubei  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖北省

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉大学中南医院

具体地址:

武昌区东湖路169号

Institution
hospital:

Zhongnan Hospital of Wuhan University

Address:

169 Donghu Road, Wuchang District

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

新型冠状病毒肺炎 

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:

探索性研究/预试验 

Study phase:

研究目的:

比较甘草酸二铵肠溶胶囊联合维C在临床标准抗病毒治疗基础上治疗普通型新型冠状病毒肺炎住院患者的疗效和安全性。 

Objectives of Study:

Evaluate the efficacy and safety of Diammonium Glycyrrhizinate Enteric-coated Capsules combined with vitamin C tablets in inpatient with common 2019-nCoV infection in the basic of clinical standard antiviral treatment. 

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)年龄≥18周岁至≤75周岁,男性或女性; 2)体重40-100kg,且BMI≥18kg/m2; 3)确诊为普通型新型冠状病毒感染的肺炎的住院患者; 4)具有发热、呼吸道等症状,影像学可见肺炎表现; 5)病原学证据阳性检测结果在72小时以内者; 6)已行手术绝育,或试验期间采取有效避孕措施; 7)同意参加本试验并自愿签署知情同意书者。 

Inclusion criteria

1. Aged 18-75 years male or female; 2. Body weight 40-100 kg and BMI >= 18kg/m2; 3. Been Confirmed with commom 2019-nCoV pneumonia inpatient; 4. With fever, respiratory tract and other symptoms, imaging shows pneumonia; 5. 2019-nCoV nucleic acid test was positive by pathogenic detection within 72 hours; 6. Have undergone surgical sterilization or take effective contraception during the trial; 7. Written the informed consent. 

排除标准:

1) 合并其它病毒如HCV、HIV、梅毒等感染者; 2)入组前3天内使用过非甾体抗炎类药物; 3) 患有严重的肝脏疾病; 4) 已知对试验药品或者其辅料有过敏史; 5) 合并有如下危险因素之一:①慢性阻塞性肺疾病、支气管哮喘等慢性呼吸系统疾病;②先天性心脏病、充血性心力衰竭、冠状动脉疾病等严重心血管疾病,高血压除外;③神经系统及神经肌肉疾病,如脑瘫、癫痫、中风、智力障碍、肌肉营养不良或脊髓损伤等;④镰状细胞病等严重血液系统疾病;⑤恶性肿瘤 6) 妊娠期或哺乳期; 7) 最近3个月内参加过其它药物临床试验者; 8) 研究者认为不适宜参加本临床试验者。 

Exclusion criteria:

1. Infected with other viruses such as HCV, HIV, and syphilis; 2. Used non-steroidal anti-inflammatory drugs within 3 days before enrollment; 3. Have severe liver disease; 4. Those who are known to be allergic to the test drug and its ingredients; 5. Any of the following risk factors: 1) Chronic respiratory diseases such as chronic dual lung disease, acute bronchial respiratory disease; 2) Severe cardiovascular diseases such as congenital hypertension, congestive heart failure, coronary artery disease, except hypertension; 3) Nervous system and neuromuscular diseases, such as cerebral palsy, epilepsy, stroke,Intellectual Disability, muscular dystrophy or spinal cord injury, etc .; 4) Severe blood system diseases such as sickle cell disease; 5) Malignant tumor. 6. Pregnancy or breastfeeding,or positive pregnancy test in a predose examination; 7. Patients who participated in other clinical trials within the last 3 months; 8. Patients who are pregnant or in lactation period. 

研究实施时间:

Study execute time:

From2020-02-12To 2020-05-12 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

experimental group

Sample size:

干预措施:

甘草酸二铵肠溶胶囊(口服,150mg,每天服药3次)+维生素C片(口服,0.5g,每天服药1次)+临床标准抗病毒治疗

干预措施代码:

Intervention:

Diammonium Glycyrrhizinate Enteric-coated Capsules (oral, 150mg, Tid), Vitamin C tablets (oral, 0.5g, QD) and clinical standard antiviral treatment

Intervention code:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

临床标准抗病毒治疗

干预措施代码:

Intervention:

clinical standard antiviral treatment

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):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉大学中南医院 

单位级别:

三级甲等 

Institution
hospital:

Zhongnan Hospital of Wuhan University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

病毒感染症状的改变

指标类型:

次要指标 

Outcome:

Time to improvement of Virus infection symptoms

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/治愈出院时间

指标类型:

次要指标 

Outcome:

Length of hospitalization /Healed and discharged

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸道标本新冠状病毒核酸检测阴转时间

指标类型:

次要指标 

Outcome:

Time to conversion of 2019-nCoV RNA result from RI sample

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

阻断轻中度患者向重度转移的比率

指标类型:

次要指标 

Outcome:

Rate of preventing mild to moderate patients from shifting to severe patients

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床恢复时间

指标类型:

主要指标 

Outcome:

Time to Clinical recovery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部炎症吸收的改变

指标类型:

次要指标 

Outcome:

Changes in lung inflammation 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:

体温复常时间

指标类型:

次要指标 

Outcome:

Time to temperature recovery

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:

咽拭子

组织:

Sample Name:

Throat swab

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 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):

由统计师用SAS软件生成随机分配表,研究者根据受试者筛选成功的先后顺序获取随机号。

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

The statistician uses SAS software to generate the random assignment table, and the researcher obtains the random number according to the sequence of successful screening of the subjects.

盲法:

开放

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:

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):

发表文章和学术会议报告

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

published articles and academic conference reports

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:

病例报告表 电子采集和管理系统

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

CRF、EDC

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-02-13
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