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Multi-Center Clinical Study on the Treatment of Patients with Novel Coronavirus Pneumonia (COVID-19) by Ebastine
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注册号:

Registration number:

ChiCTR2000030535 

最近更新日期:

Date of Last Refreshed on:

2020-03-06 

注册时间:

Date of Registration:

2020-03-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

依巴斯汀治疗新型冠状病毒 (COVID-19) 感染肺炎的多中心临床随机对照研究 

Public title:

Multi-Center Clinical Study on the Treatment of Patients with Novel Coronavirus Pneumonia (COVID-19) by Ebastine 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

依巴斯汀治疗新型冠状病毒 (COVID-19) 感染肺炎的多中心临床随机对照研究 

Scientific title:

Multi-Center Clinical Study on the Treatment of Patients with Novel Coronavirus Pneumonia (COVID-19) by Ebastine 

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:

张丹 

研究负责人:

许治华 

Applicant:

Zhang Dan 

Study leader:

Xu Zhihua 

申请注册联系人电话:

Applicant telephone:

+86 15281660541 

研究负责人电话:

Study leader's telephone:

+86 18508160990 

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:

834146156@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1121733818@qq.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:

四川省绵阳市警钟街常家巷12号 

研究负责人通讯地址:

四川省绵阳市中心医院 

Applicant address:

12 Changjia Lane, Jingzhong Street, Mianyang, Sichuan 

Study leader's address:

Mianyang Central Hospital of Sichuan province 

申请注册联系人邮政编码:

Applicant postcode:

621000 

研究负责人邮政编码:

Study leader's postcode:

621000 

申请人所在单位:

绵阳市中心医院 

Applicant's institution:

Mianyang Central 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:

2020009 

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:

武汉市红十字会医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Wuhan Red Cross Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-20 

伦理委员会联系人:

熊念 

Contact Name of the ethic committee:

Xiong Nian 

伦理委员会联系地址:

武汉市江汉区香港路392号 

Contact Address of the ethic committee:

392 Hong Kong Road, Jianghan District, Wuhan, Hubei 

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:

武汉市红十字会医院 

Primary sponsor:

Wuhan Red Cross Hospital 

研究实施负责(组长)单位地址:

武汉市江汉区香港路392号 

Primary sponsor's address:

392 Hong Kong Road, Jianghan 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):

四川省

市(区县):

绵阳市

Country:

China

Province:

Sichuan

City:

Mianyang

单位(医院):

绵阳市中心医院

具体地址:

警钟街常家巷12号

Institution
hospital:

Mianyang Central Hospital

Address:

12 Changjia Lane, Jingzhong Street

国家:

中国

省(直辖市):

湖北省

市(区县):

武汉市

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉市红十字会医院

具体地址:

江汉区香港路392号

Institution
hospital:

Wuhan Red Cross Hospital

Address:

392 Hong Kong Road, Jianghan District

国家:

中国

省(直辖市):

四川省

市(区县):

成都市

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

外南国学巷37号

Institution
hospital:

West China Hospital of Sichuan University

Address:

37 Guoxue Lane, Wuhou District

经费或物资来源:

自筹 

Source(s) of funding:

self-funding 

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:

为积极防控新型冠状病毒感染的肺炎,评估依巴斯汀在治疗 2019-nCoV 感染肺炎的普通型,重型成年住院患者中的疗效和安全性。 

Objectives of Study:

To actively prevent and control novel coronavirus-infected pneumonia and evaluate the efficacy and safety of ebastine in the treatment of common and severe adult patients with 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)呼吸道标本或血液标本实时荧光 RT?PCR 检测新型冠状病毒核酸阳性; (3)呼吸道标本或血液标本病毒基因测序,与已知的新型冠状病毒高度同源; (4)根据《新型冠状病毒感染的肺炎诊疗方案(试行第六版)》确诊为新型冠状病毒肺炎的普通型患者,即具有发热和/或呼吸道症状,且胸部 CT 可见肺炎表现。 (5)可纳入部分重型患者。即复合下列任何一条:①呼吸窘迫,RR≥30 次/分;②静息状态下,指氧饱和度≤93%;③动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg。 

Inclusion criteria

1. Aged 18 to 75 years; 2. Real-time fluorescence RT-PCR detection of nucleic acid positive of novel coronavirus in respiratory tract specimens or blood preparation; 3. Sequencing of virus genes in respiratory tract specimens or blood preparation, highly homologous to known novel coronavirus ; 4. The patients are diagnosed with common type of novel coronavirus pneumonia according to the Pneumonia Diagnosis and Treatment Program for Novel Coronavirus Infection (Trial Version 6), and have fever and/or respiratory symptoms, and shows pneumonia in the chest CT. 5. Can be included in some severe patients, consistent with any of the following: (1) Respiratory distress, RR >= 30 times/min; (2) Under quiescent condition, Oxygen saturation <= 93%; (3) Arterial partial pressure of oxygen(PaO2)/oxygen concentration(FiO2)<= 300mmHg. 

排除标准:

(1)合并高血压、糖尿病、冠心病等基础疾病; (2)合并恶性肿瘤或有恶性肿瘤病史; (3)妊娠或哺乳期妇女; (4)患有严重精神疾病; (5)6 个月内有不稳定性心绞痛或心肌梗塞史,冠状动脉造影;提示冠状动脉主要分支重度狭窄; (6)6 个月内有脑梗塞或脑出血病史; (7)对干扰素制剂不耐受或过敏者; (8)经研究者判断患者不适宜纳入试验。 

Exclusion criteria:

(1) Combined with high blood pressure, diabetes, coronary heart disease and other underlying disease; (2) Combined with malignant tumor or a medical history of malignant tumor; (3) Pregnant or lactating women; (4) Suffering from severe mental illness; (5) Medical history of unstable angor pectoris or myocardial?infarction within 6 months, coronary arteriography; it indicates severe stenosis of the main branch of the coronary artery; (6) Medical history of cerebral infarction or cerebral hemorrhage within 6 months; (7) Intolerant or allergic to interferon preparations; (8) The investigator determined that the patients were not eligible for the trial. 

研究实施时间:

Study execute time:

From2020-02-20To 2020-03-30 

征募观察对象时间:

Recruiting time:

From2020-02-20To 2020-03-30 

干预措施:

Interventions:

组别:

试验组

样本量:

50

Group:

experimental group

Sample size:

干预措施:

依巴斯汀10mg bid + α-干扰素雾化吸入500万U bid+洛匹那韦200 mg ,每次2粒,bid

干预措施代码:

Intervention:

ebastine 10mg bid, nterferon-alpha aerosol inhalation 5million U bid and Lopinavir 200 mg, 2 capsules at a time, bid

Intervention code:

组别:

对照组

样本量:

50

Group:

control group

Sample size:

干预措施:

α-干扰素雾化吸入500万U bid+洛匹那韦200 mg ,每次2粒,bid

干预措施代码:

Intervention:

interferon-alpha aerosol inhalation 5million U bid and Lopinavir 200 mg, 2 capsules at a time, bid

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):

武汉市 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉市红十字会医院 

单位级别:

二级甲等 

Institution
hospital:

Wuhan Red Cross Hospital  

Level of the institution:

Secondary A 

测量指标:

Outcomes:

指标中文名:

临床治愈时间

指标类型:

主要指标 

Outcome:

Clinical therapeutic course

Type:

Primary indicator 

测量时间点:

测量方法:

从开始治疗到发热、呼吸频率、血氧饱和度转为正常和咳嗽缓解,持续至少 72 小时。胸部 CT 提示炎症明显吸收,且连续两次呼吸道病原核酸检测阴性(采样时间间隔至少 1d)。

Measure time point of outcome:

Measure method:

Fever, respiratory rate, blood oxygen saturation turned to normal and cough relieved for at least 72 hours. Chest CT showed that the inflammation was obviously absorbed, and the nucleic acid of respiratory pathogens was negative twice in a row (the sampling interval was at least 1 day).

指标中文名:

全因死亡

指标类型:

次要指标 

Outcome:

All-cause death

Type:

Secondary indicator 

测量时间点:

28 天

测量方法:

Measure time point of outcome:

28 days

Measure method:

指标中文名:

不良反应

指标类型:

次要指标 

Outcome:

Adverse events

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病原学检测

指标类型:

主要指标 

Outcome:

Pathogenic detectio

Type:

Primary indicator 

测量时间点:

每3天

测量方法:

实时荧光RT-PCR

Measure time point of outcome:

every 3 days

Measure method:

RT-PCR

指标中文名:

胸部 CT

指标类型:

主要指标 

Outcome:

Chest CT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

实验室指标(血常规、心肌酶谱、炎性细胞因子等)

指标类型:

主要指标 

Outcome:

Laboratory indicators (blood routine, myocardial enzyme spectrum, inflammatory cytokines, etc.)

Type:

Primary 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 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):

本研究采用多中心、随机、平行对照试验设计。在各个研究中心的研究都具有随机性。本研究采用单盲设计,研究对象不知道自己是试验组还是对照组。每个中心入组的受试者由主管医生随机编码入组试验组或者对照组。 研究采用随机分组方法:一组为常规治疗联合依巴斯汀治疗组,一组为常规抗病毒治疗组,任何时间发现病情进展均可停止治疗或进行联合干预治疗。

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

A multicenter, randomized, parallel controlled trial design was used in this study.The research in each research center is random.The study was conducted in a single blind design, and the subjects did not know whether they were in the experimental group or the control group.

盲法:

对患者施盲

Blinding:

Blind method for subjects.

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:

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):

试验完成后以论文或者报告形式公开

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

When the research is completed, the data will be made public in the form of a paper or report

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:

有/Yes

注册人:

Name of Registration:

 2020-03-06
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