Today is 2020-06-06

A randomized, open-label, blank-controlled, multicenter trial for Shuang-Huang-Lian oral solution in the treatment of ovel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000029605 

最近更新日期:

Date of Last Refreshed on:

2020-05-15 

注册时间:

Date of Registration:

2020-02-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

双黄连口服液治疗新型冠状病毒肺炎(COVID-19)有效性和安全性的随机、开放、平行对照、多中心临床试验 

Public title:

A randomized, open-label, blank-controlled, multicenter trial for Shuang-Huang-Lian oral solution in the treatment of ovel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

双黄连口服液治疗新型冠状病毒肺炎(COVID-19)有效性和安全性的随机、开放、平行对照、多中心临床试验 

Scientific title:

A randomized, open-label, blank-controlled, multicenter trial for Shuang-Huang-Lian oral 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:

ChiMCTR2000002975 

申请注册联系人:

刘彩玲 

研究负责人:

汪道文/赵建平 

Applicant:

Liu Cailing 

Study leader:

Wang Daowen, Zhao Jianping 

申请注册联系人电话:

Applicant telephone:

+86 13810120575 

研究负责人电话:

Study leader's telephone:

+86 13971301060 

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:

liucailing@hayao.com 

研究负责人电子邮件:

Study leader's E-mail:

dwwang@tjh.tjmu.edu.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:

北京市朝阳区朝外大街16号中国人寿大厦1204 

研究负责人通讯地址:

湖北省武汉市解放大道1095号 

Applicant address:

Room 1204, PICC Building, 16 Chaowai Street, Chaoyang District, Beijing 

Study leader's address:

1095 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:

哈药集团三精制药有限公司 

Applicant's institution:

Harbin Pharmaceutical Group Sanjing Pharmaceutical Holding Co.,Ltd. 

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:

TJ-C20200113 

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同济医院伦理委员会 

Name of the ethic committee:

Ethical Committed of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-04 

伦理委员会联系人:

杜艾桦 

Contact Name of the ethic committee:

Du Aihua 

伦理委员会联系地址:

湖北省武汉市解放大道1095号同济医院行政楼10楼 

Contact Address of the ethic committee:

Tenth Floor, Administration Building, Tongji Hospital, 1095 Jiefang Avenue, 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:

华中科技大学同济医学院附属同济医院 

Primary sponsor:

Tongji Hospital, Tongji Medical College, 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1095号 

Primary sponsor's address:

1095 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同济医院

具体地址:

解放大道1095号

Institution
hospital:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address:

1095 Jiefang Avenue

经费或物资来源:

哈药集团三精制药有限公司 

Source(s) of funding:

Harbin Pharmaceutical Group Sanjing Pharmaceutical Holding Co.,Ltd. 

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:

1. 评价双黄连口服液治疗新型冠状病毒感染的肺炎的临床疗效。 2. 评价双黄连口服液治疗新型冠状病毒感染的肺炎的安全性。 

Objectives of Study:

1. To evaluate the clinical efficacy of Shuanghuanglian oral solution in the treatment of pneumonitis caused by new coronavirus; 2. To evaluate the safety of Lianhua Qingwen Capsule / Granule in the treatment of pneumonitis caused by new coronavirus infection.  

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. 确诊的新型冠状病毒感染的肺炎患者。 2. 年龄18岁以上(含18岁)。 3. 自愿签署书面的知情同意书。 

Inclusion criteria

1. Patients with confirmed new coronavirus-infected pneumonia; 2. Above 18 years old (inclusive); 3. Voluntarily sign written informed consent.  

排除标准:

1. 重症肺炎需要机械通气、危重型新型冠状病毒感染肺炎患者; 2. 预计48小时内死亡者; 3. 原发性免疫缺陷病、获得性免疫缺陷综合征、先天性呼吸道畸形、先天性心脏病、胃食管反流症、肺发育异常等基础疾病引起的呼吸道感染,有明确细菌感染证据; 4. 有以下状况的受试者: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。胸部CT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; 5. 经研究者判断,既往或现在患有的疾病,可能影响患者参加试验或影响研究的转归,包括:恶性病、自身免疫性疾病、严重营养不良、肝肾疾患、血液病、神经系统疾病、和内分泌疾病;现患有严重影响免疫系统的疾病,如:人类免疫缺陷病毒(HIV)感染,或血液系统,或脾切除、器官移植术等; 6. 精神状态不能合作者,患有精神性疾病、不能自制、不能明确表达者; 7. 过敏体质(如对两种或以上药物、食物过敏者)或对本品及常规治疗药物等有过敏史者; 8. 有药物滥用或依赖史; 9. 妊娠或哺乳期妇女; 10. 近3个月内参加过其他药物临床试验者; 11. 研究者认为不适宜参加临床试验者。  

Exclusion criteria:

1. Severe pneumonia requires mechanical ventilationcritically severe cases; 2. Estimated Time of Death is less than 48 hours; 3. There is clear evidence of bacterial infection in respiratory tract infections caused by basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformations, congenital heart disease, gastroesophageal reflux disease, and abnormal lung development; 4. Subjects with the following conditions: asthma requiring daily treatment, any other chronic respiratory disease, respiratory bacterial infections such as purulent tonsillitis, acute tracheobronchitis, sinusitis, otitis media, and other respiratory tracts diseases that affecting clinical trial evaluation . Chest CT confirmed that patients with basic pulmonary diseases such as severe pulmonary interstitial lesions and bronchiectasis; 5. In the opinion of the investigator, previous or present illnesses may affect patients' participation in the trial or influence the outcome of the study, including: malignant disease, autoimmune disease, liver and kidney disease, blood disease, neurological disease, and endocrine Disease; currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or the blood system, or splenectomy, organ transplantation, etc .; 6. Mental state unable to cooperate, suffering from mental illness, unable to control, unable to express clearly 7. An allergic condition, such as a history of allergies to two or more drugs or foods, or a known allergy to the ingredients of the drug; 8. Patients with a history of substance abuse or dependence; 9. Pregnant or lactating women; 10. Patients who participated in other clinical trials within the last 3 months; 11. The investigator believes that there are any factors that are not suitable for enrollment or affect the evaluation of the efficacy. 

研究实施时间:

Study execute time:

From2020-02-05To 2021-02-05 

干预措施:

Interventions:

组别:

低剂量组

样本量:

100

Group:

Low dose group

Sample size:

干预措施:

双黄连一次2支,每日三次, 常规治疗

干预措施代码:

Intervention:

Shuanghuanglian 2 bottles/time, 3 times a day; Routine treatment.

Intervention code:

组别:

中剂量组

样本量:

100

Group:

Medium dose of group

Sample size:

干预措施:

一次4支,每日三次; 常规治疗.

干预措施代码:

Intervention:

Shuanghuanglian 4 bottles/time, 3 times a day; routine treatment.

Intervention code:

组别:

高剂量组

样本量:

100

Group:

High dose of group

Sample size:

干预措施:

双黄连一次6支,每日三次

干预措施代码:

Intervention:

Shuanghuanglian 6 bottles/time, 3 times a day; routine treatment.

Intervention code:

组别:

对照组

样本量:

100

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):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

黑龙江省传染病防治院 

单位级别:

三级甲等 

Institution
hospital:

Infectious Disease Hospital of Heiongjiang Province  

Level of the institution:

Tertiary A 

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):

同济医院 

单位级别:

三级甲等 

Institution
hospital:

Tongji Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

黑龙江省 

市(区县):

哈尔滨市 

Country:

china 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

哈尔滨市传染病医院 

单位级别:

三级甲等 

Institution
hospital:

Harbin infectious diseases hospital  

Level of the institution:

tertiary A 

国家:

中国 

省(直辖市):

安徽 

市(区县):

合肥 

Country:

China 

Province:

Anhui 

City:

Hefei 

单位(医院):

安徽省立医院 

单位级别:

三级甲等 

Institution
hospital:

Anhui Province HOspital  

Level of the institution:

tertiary A 

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiang Su 

City:

Nanjing 

单位(医院):

南京市第二医院 

单位级别:

三级甲等 

Institution
hospital:

The second hospital of Nanjing  

Level of the institution:

tertiary A 

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):

中国人民解放军中部战区总医院 

单位级别:

三级甲等 

Institution
hospital:

Central Theater General Hospital of PLA  

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:

Time to disease 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:

新型冠状病毒转阴时间及转阴率

指标类型:

次要指标 

Outcome:

Time and rate of coronavirus become negative

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

主要症状(发热、乏力、咳嗽)消失率及消失时间

指标类型:

次要指标 

Outcome:

Clearance rate and time of main symptoms (fever, fatigue, cough)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病情加重(转入RICU)时间

指标类型:

次要指标 

Outcome:

Exacerbation (transfer to RICU) time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

次要指标 

Outcome:

Routine blood test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生化指标

指标类型:

次要指标 

Outcome:

Biochemical Indicators

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫指标

指标类型:

次要指标 

Outcome:

immune indices

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:

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):

统计学专业人员用电脑生成随机数字表,由医生将所有患者按照就诊先后顺序编号。

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

Statistical professionals use a computer to generate a table of random numbers, and all patients are numbered by the doctor in order.

盲法:

开放

Blinding:

open label

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):

Epi

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

Epi

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:

数据资料分别采用纸质版和电子版进行采集和统计。纸质版将保留原始病例记录表,同时采用电子系统进行网上登记

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

Data were collected and counted by paper edition and electronic edition respectively.The paper version will retain the original case records, while an electronic system will be used for online registration.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-06
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