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评价参芪扶正注射液治疗新型冠状病毒肺炎 (COVID-19)有效性和安全性的多中心、随机、开放、对照研究
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注册号:

Registration number:

ChiCTR2000029780 

最近更新日期:

Date of Last Refreshed on:

2020-02-18 

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:

评价参芪扶正注射液治疗新型冠状病毒肺炎 (COVID-19)有效性和安全性的多中心、随机、开放、对照研究 

Public title:

A multicenter, randomized, open, controlled trial for the efficacy and safety of Shen-Qi Fu-Zheng injection 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:

评价参芪扶正注射液治疗新型冠状病毒肺炎 (COVID-19)有效性和安全性的多中心、随机、开放、对照研究 

Scientific title:

A multicenter, randomized, open, controlled trial for the efficacy and safety of Shen-Qi Fu-Zheng injection 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:

ChiMCTR2000003004 

申请注册联系人:

孙虹 

研究负责人:

郑昕 

Applicant:

Hong Sun 

Study leader:

Xin Zheng 

申请注册联系人电话:

Applicant telephone:

+86 13928016977 

研究负责人电话:

Study leader's telephone:

+86 18602724981 

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:

ratsh@126.com 

研究负责人电子邮件:

Study leader's E-mail:

Xin11@hotmail.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:

广东省韶关市工业西路89号 

研究负责人通讯地址:

湖北省武汉市解放大道1277号 

Applicant address:

89 Gongye Road West, Shaoguan, Guangdong, China 

Study leader's address:

1277 Jiefang Avenue, 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:

丽珠集团利民制药厂 

Applicant's institution:

Lizhu Group Limin Pharmaceutical Factory 

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:

【2020】伦理字(0012)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:

华中科技大学同济医学院附属协和医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-06 

伦理委员会联系人:

张颖聪 

Contact Name of the ethic committee:

Yingchong Zhang 

伦理委员会联系地址:

湖北省武汉市解放大道1277号 

Contact Address of the ethic committee:

1277 Jiefang Avenue, Wuhan, Hubei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 027-85726685 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

whunionlunli@126.com 

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 affiliated to Tongji Medical College of Huazhong University of Science and Technology 

研究实施负责(组长)单位地址:

湖北省武汉市解放大道1277号 

Primary sponsor's address:

1277 Jiefang Avenue, 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:

解放大道1277号

Institution
hospital:

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Address:

1277 Jiefang Avenue

经费或物资来源:

丽珠集团利民制药厂 

Source(s) of funding:

Lizhu Group Limin Pharmaceutical Factory 

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:

上市后药物 

Study phase:

研究目的:

评价参芪扶正注射液治疗新型冠状病毒感染的肺炎的有效性和安全性。 

Objectives of Study:

To evaluate the efficacy and safety of shenqi fuzheng injection in the treatment of pneumonia caused by novel coronavirus. 

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; 2) 符合《新型冠状病毒肺炎诊疗方案》的确诊标准,确诊为新型冠状病毒感染的肺炎患者; 3) 肺炎严重指数(PSI)分级为Ⅲ~Ⅳ级者; 4) 患者入组时出现症状病程需≤8天; 5) 自愿受试并遵守医院有关管理规定,能配合完成规定的各项检查; 6) 试验前自愿签署知情同意书。 

Inclusion criteria

1) Aged >= 18 years; 2) In line with the diagnostic criteria of "new coronavirus pneumonia diagnosis program", the patient was diagnosed as pneumonia infected by the new coronavirus; 3) Severe pneumonia index (PSI) class for III ~ IV; 4) The course of symptoms should be less than or equal to 8 days; 5) Volunteers and comply with the hospital regulations, can cooperate with the completion of the prescribed inspection; 6) Voluntary informed consent was signed prior to the trial. 

排除标准:

1) 符合一下任意一条情况者: 呼吸窘迫,RR≥30次/分; 静息状态下,指氧饱和度≤93%; 动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg(1mmHg=0.133kPa); 出现呼吸衰竭,且需要机械通气; 出现休克; 合并其他器官功能衰竭需ICU监护治疗; 预计72小时内会转移到非研究医院进行治疗。 2) 重症流行性感冒以及具有并发症的流感患者(有流行性感冒并发症者,如继发细菌性肺炎、其它病原菌所致肺炎及其它病毒性肺炎等);或者患者因重症流感住院; 3) 其他上呼吸道感染患者:如需每日治疗的哮喘,任何其他慢性呼吸道疾病,呼吸系统细菌感染如化脓性扁桃体炎,急性气管支气管炎,鼻窦炎,中耳炎等其他影响临床试验评估的呼吸道疾病。影像学证实存在严重的肺间质病变、支气管扩张等基础性肺部疾病患者 4) 经研究者判断既往或现在患有疾病可能影响参加试验或研究的转归:如不可切除的恶性肿瘤、血液病、活动性出血、恶液质、肝肾疾病、神经系统疾病、内分泌系统疾病等; 5) 患有严重影响免疫系统的疾病:如HIV感染、脾切除、器官移植术等; 6) 妊娠期或哺乳期的女性; 7) 试验药物组成成分过敏,或过敏体质者; 8) 有药物滥用史的患者; 9) 近3个月内参加过其它临床试验者; 10) 研究者认为不适宜参加本临床试验者。 

Exclusion criteria:

1)One of the following conditions: Respiratory distress, RR >= 30 times/min; At rest, oxygen saturation is less than 93%; Artial arterial oxygen pressure (PaO2)/oxygen absorption concentration (FiO2) <= 300mmHg (1mmHg=0.133kPa); Respiratory failure is present and mechanical ventilation is required; Shock; Combined with other organ failure requires intensive care unit; It is expected to be transferred to a non-study hospital within 72 hours. 2)Severe influenza and influenza patients with complications (such as secondary bacterial pneumonia, pneumonia caused by other pathogens and other viral pneumonia);Or the patient is hospitalized with severe influenza; 3)Patients with other upper respiratory tract infections: asthma requiring daily treatment, any other chronic respiratory diseases, respiratory bacterial infections such as suppurative tonsillitis, acute tracheal bronchitis, sinusitis, otitis media and other respiratory diseases affecting clinical trial evaluation.Imaging confirmed the existence of severe pulmonary interstitial lesions, bronchiectasis and other basic pulmonary diseases; 4)Past or present diseases may affect the outcome of the study, such as unresectable malignant tumors, hematological diseases, active bleeding, malignant fluid, liver and kidney diseases, nervous system diseases, endocrine system diseases, etc.; 5)Suffering from diseases that seriously affect the immune system, such as HIV infection, splenectomy, organ transplantation, etc.; 6)A woman who is pregnant or breastfeeding; 7)Test drug components allergy, or allergic constitution; 8)Patients with a history of substance abuse; 9)Participants in other clinical trials in the last 3 months; 10)The investigator considers it inappropriate to participate in this clinical trial. 

研究实施时间:

Study execute time:

From2020-02-06To 2020-06-09 

征募观察对象时间:

Recruiting time:

From2020-02-14To 2020-04-14 

干预措施:

Interventions:

组别:

试验组

样本量:

80

Group:

experimental group

Sample size:

干预措施:

常规治疗+参芪扶正注射

干预措施代码:

Intervention:

Routine treatment and Shenqi Fuzheng Injection

Intervention code:

组别:

对照组

样本量:

80

Group:

control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Routine 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 

市(区县):

黄冈 

Country:

China 

Province:

Hubei 

City:

Huanggang 

单位(医院):

黄冈市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Huanggang Central Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

湖北 

市(区县):

浠水 

Country:

China 

Province:

Hubei 

City:

Xishui 

单位(医院):

浠水县人民医院 

单位级别:

三级医院 

Institution
hospital:

Xishui County People's Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

湖北 

市(区县):

黄梅 

Country:

China 

Province:

Hubei 

City:

Huangmei 

单位(医院):

黄梅县人民医院 

单位级别:

二级 

Institution
hospital:

Huangmei County People's Hospital  

Level of the institution:

Secondary 

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):

武汉市普仁医院 

单位级别:

三甲医院 

Institution
hospital:

Wuhan Puren Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

湖北 

市(区县):

蕲春 

Country:

China 

Province:

Hubei 

City:

Qichun 

单位(医院):

蕲春县人民医院 

单位级别:

二甲医院 

Institution
hospital:

Qichun County People's Hospital  

Level of the institution:

Secondary A 

国家:

中国 

省(直辖市):

湖北 

市(区县):

孝感 

Country:

China 

Province:

Hubei 

City:

Xiaogan 

单位(医院):

孝感市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Xiaogan Central Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

疾病痊愈时间

指标类型:

主要指标 

Outcome:

Recovery time

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 RNA 转阴率

指标类型:

次要指标 

Outcome:

COVID-19 RNA negative conversion rate

Type:

Secondary indicator 

测量时间点:

治疗结束后、治疗开始后第 28 天

测量方法:

Measure time point of outcome:

at the end of the treatment, on the 28th day of treatment

Measure method:

指标中文名:

主要症状(乏力、呼吸困难)的消失率

指标类型:

次要指标 

Outcome:

Disappearance rate of main symptoms(fatigue, dyspnea)

Type:

Secondary indicator 

测量时间点:

治疗结束后、治疗开始后第 28 天

测量方法:

Measure time point of outcome:

at the end of the treatment, on the 28th day of treatment

Measure method:

指标中文名:

不良事件

指标类型:

附加指标 

Outcome:

Adverse event

Type:

Additional 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:

静脉

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:

尿液

组织:

膀胱

Sample Name:

urine

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 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):

统计师采用按中心分层随机的方法。

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

The statisticians used a method of stratification and randomization by center.

盲法:

open label

Blinding:

open label

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

中国临床试验注册中心 网址:www.chictr.org.cn

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

Chinese clinical trial registry

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:

无/No

注册人:

Name of Registration:

 2020-02-13
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