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连花清瘟胶囊/颗粒治疗新型冠状病毒肺炎 (COVID-19) 随机、对照临床试验
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注册号:

Registration number:

ChiCTR2000029434 

最近更新日期:

Date of Last Refreshed on:

2020-03-09 

注册时间:

Date of Registration:

2020-02-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

连花清瘟胶囊/颗粒治疗新型冠状病毒肺炎 (COVID-19) 随机、对照临床试验 

Public title:

A randomized, open-label, blank-controlled trial for Lian-Hua Qing-Wen Capsule /Granule 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:

连花清瘟胶囊/颗粒治疗新型冠状病毒肺炎 (COVID-19) 随机、对照临床试验 

Scientific title:

A randomized, open-label, blank-controlled trial for Lian-Hua Qing-Wen Capsule /Granule 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:

ChiMCTR2000002950 

申请注册联系人:

韩硕龙 

研究负责人:

钟南山/张伯礼/李兰娟/段钟平/ 李兴旺/刘清泉/宋元林/贾振华 

Applicant:

Han Shuolong 

Study leader:

Zhong Nanshan/Zhang Boli/Li Lanjuan/Duan Zhongping/Li Xingwang/Liu Qingquan/Song Yuanlin/Jia Zhenhua 

申请注册联系人电话:

Applicant telephone:

+86 13582167153 

研究负责人电话:

Study leader's telephone:

+86 0311 83855881 

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:

hanshuolong@126.com 

研究负责人电子邮件:

Study leader's E-mail:

jiactm@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:

石家庄天山大街238号 

研究负责人通讯地址:

石家庄市桥西区新石北路385号 

Applicant address:

238 Tianshan Street, Shijiazhuang, Hebei, China  

Study leader's address:

385 Xinshi Road North, Qiaoxi District, Shijiazhuang, Hebei, 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:

石家庄以岭药业股份有限公司 

Applicant's institution:

Shijiazhuang Yiling Pharmaceutical 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:

2020LCKY-001 

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:

河北以岭医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Hebei Yiling Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-31 

伦理委员会联系人:

孙永辉 

Contact Name of the ethic committee:

Sun YongHui 

伦理委员会联系地址:

石家庄市桥西区新石北路385号 

Contact Address of the ethic committee:

385 Xinshi Road North, Qiaoxi District, Shijiazhuang, Hebei, 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:

河北以岭医院 武汉大学人民医院 

Primary sponsor:

Hebei Yiling Hospital, Renmin Hospital of Wuhan University 

研究实施负责(组长)单位地址:

石家庄市桥西区新石北路385号、湖北武汉武昌区张之洞路(原紫阳路)99号解放路238号  

Primary sponsor's address:

385 Xinshi Road North, Qiaoxi District, Shijiazhuang, Hebei; 238 Jiefang Road, 99 Zhangzhidong Road, Wuchang District, 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):

河北

市(区县):

石家庄

Country:

China

Province:

Hebei

City:

Shijiazhuang

单位(医院):

河北以岭医院

具体地址:

桥西区新石北路385号

Institution
hospital:

Hebei Yiling Hospital

Address:

385 Xinshi Road North, Qiaoxi District

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):

武汉大学人民医院

具体地址:

武昌区张之洞路(原紫阳路)99号解放路238号

Institution
hospital:

Renmin Hospital of Wuhan University

Address:

238 Jiefang Road, 99 Zhangzhidong Road, Wuchang District

经费或物资来源:

石家庄以岭药业股份有限公司 

Source(s) of funding:

Shijiazhuang Yiling Pharmaceutical Co., Ltd. 

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:

1. 评价连花清瘟胶囊/颗粒治疗新型冠状病毒感染的肺炎的临床疗效。 2. 评价连花清瘟胶囊/颗粒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 Lianhua Qingwen Capsule / Granule 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.入组时具备主要症状(发热、咳嗽、乏力)任一症状。 4.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. At the time of enrollment, the patient had any of the main symptoms (fever, cough, fatigue); 4. Voluntarily sign written informed consent. 

排除标准:

1.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。 2.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。 3.重症肺炎需要机械通气者。 4.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、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; 5.孕妇或哺乳期女性。 6.近3个月内参与过其他临床试验的患者。 7.过敏体质,如对两种或以上药物或食物过敏史者,或已知对本药成分过敏者。 8.研究者认为存在任何不适合入组或者影响受试者疗效评价的因素。 

Exclusion criteria:

1. 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; 2. 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; 3. Severe pneumonia requires mechanical ventilation; 4. 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 .; 5. Pregnant or lactating women; 6. Patients who participated in other clinical trials within the last 3 months; 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. 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:

From2020-02-01To 2020-12-01 

干预措施:

Interventions:

组别:

常规治疗+连花清瘟胶囊/颗粒

样本量:

120

Group:

Routine treatment + Lianhua Qingwen Capsules/granules

Sample size:

干预措施:

胶囊 4粒/次 或 颗粒1袋/次,一日3次

干预措施代码:

Intervention:

4 capsules / time or 1 bag / time, 3 times a day

Intervention code:

组别:

常规治疗

样本量:

120

Group:

Conventional treatment

Sample size:

干预措施:

按第四版诊疗方案中规定治疗,不使用中药

干预措施代码:

Intervention:

Treat as prescribed in the fourth edition of the diagnosis and treatment plan, without using traditional Chinese medicine

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):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市第九医院 

单位级别:

三级医院 

Institution
hospital:

Ninth Hospital of Wuhan  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

河北 

市(区县):

 

Country:

China 

Province:

Hebei 

City:

 

单位(医院):

石家庄市第五医院 

单位级别:

三级医院 

Institution
hospital:

Shijiazhuang Fifth Hospital  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

华润武钢总医院 

单位级别:

三级医院 

Institution
hospital:

CR & WISCO General Hospital  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京佑安医院 

单位级别:

三级医院 

Institution
hospital:

Beijing You'an Hospital, Capital Medical University  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学第二附属医院 

单位级别:

三级医院 

Institution
hospital:

The Second Affiliated Hospital of Chongqing Medical University  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

He'nan 

City:

 

单位(医院):

河南省传染病医院 

单位级别:

三级医院 

Institution
hospital:

He'nan Provincial Infectious Disease Hospital  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市金银潭医院 

单位级别:

三级医院 

Institution
hospital:

Wuhan Jinyintan Hospital  

Level of the institution:

Tertiary hospital 

测量指标:

Outcomes:

指标中文名:

临床症状(发热、乏力、咳嗽)痊愈率及痊愈时间

指标类型:

主要指标 

Outcome:

Clinical symptoms (fever, weakness, cough) recovery rate and 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:

治疗期间病情加重的比例(符合诊疗方案中重症、危重症定义)

指标类型:

次要指标 

Outcome:

Proportion of aggravation during treatment (in line with the definition of severe or critical illness in the treatment scheme)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CT好转的比例

指标类型:

次要指标 

Outcome:

Rate of CT improvement

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

单项症状消失率及主要症状消失时间

指标类型:

次要指标 

Outcome:

Single symptom disappearance rate and main symptom disappearance 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:

疾病痊愈比例

指标类型:

次要指标 

Outcome:

Disease recovery 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:

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:

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:

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):

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:

 2020-02-01
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