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新型重组高效复合干扰素治疗新型冠状病毒(2019-nCoV) 肺炎的多中心临床随机对照研究
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注册号:

Registration number:

ChiCTR2000029638 

最近更新日期:

Date of Last Refreshed on:

2020-05-16 

注册时间:

Date of Registration:

2020-02-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型重组高效复合干扰素治疗新型冠状病毒(2019-nCoV) 肺炎的多中心临床随机对照研究 

Public title:

A Multicenter, Randomized, Controlled trial for Recombinant Super-Compound Interferon (rSIFN-co) in the Treatment of 2019 Novel Coronavirus (2019-nCoV) Infected Pneumonia  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型重组高效复合干扰素治疗新型冠状病毒 (2019-nCoV)肺炎 的多中心临床随机对照研究 

Scientific title:

A Multicenter, Randomized, Controlled trial for Recombinant Super-Compound Interferon (rSIFN-co) in the Treatment of Novel Coronavirus (2019-nCoV) Pneumonia  

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:

李川 

研究负责人:

刘伦旭 

Applicant:

Chuan Li 

Study leader:

Lunxu Liu 

申请注册联系人电话:

Applicant telephone:

+86 15828643096 

研究负责人电话:

Study leader's telephone:

+86 18980601525 

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:

chuan08@aliyun.com 

研究负责人电子邮件:

Study leader's E-mail:

lunxu_liu@aliyun.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:

四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

610041 

研究负责人邮政编码:

Study leader's postcode:

610041 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan 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:

2020年临床试验(西药)审(10)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:

四川大学华西医院临床试验伦理委员会 

Name of the ethic committee:

Clinical Trial Ethics Committee, West China Hospital of Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-08 

伦理委员会联系人:

韩玉榕、赵芸芸 

Contact Name of the ethic committee:

Yurong Han, Yunyun Zhao 

伦理委员会联系地址:

四川省成都市武侯区国学巷37号四川大学华西医院老八教412-413室 

Contact Address of the ethic committee:

Room 412-413, Old 8th Teaching Building, West China Hospital, Sichuan University, 37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

武侯区国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxue Lane, Wuhou District

经费或物资来源:

四川大学华西医院新型冠状病毒肺炎疫情科技攻关项目(HX-2019-nCoV-016)、四川大学新型冠状病毒(2019-nCov)应急项目(0082604151006) 

Source(s) of funding:

Science and Technology Project of Novel Coronavirus Pneumonia in West China Hospital, Sichuan University; Emergency Project of Novel Coronavirus (2019-nCov) of Sichuan University 

研究疾病:

新型冠状病毒(2019-nCoV)肺炎 

Target disease:

Novel Coronavirus (2019-nCoV) Pneumonia 

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:

评估雾化吸入新型重组高效复合干扰素在治疗COVID-19感染肺炎患者中的疗效和安全性。 

Objectives of Study:

To evaluate the efficacy and safety of aerosol inhalation of recombinant super-compound interferon(rSIFN-co) in the treatment of patients with pneumonia infected with covid-19. 

药物成份或治疗方案详述:

干预组:基线抗病毒治疗药物使用洛匹那韦/利托那韦(200mg/50mg每粒)每次2粒,每日2次,或者阿比多尔,一次400mg,一日三次口服,疗程不超过10天,若该药有严重不良反应可随时停药。在此基础上,采用新型基因重组高效复合干扰素雾化吸入,每次1200万IU (21μg),加入灭菌注射用水2ml,每日2次; 对照组:基线抗病毒治疗药物使用洛匹那韦/利托那韦(200mg/50mg每粒)每次2粒,每日2次,或者阿比多尔,一次400mg,一日三次口服,疗程不超过10天,若该药有严重不良反应可随时停药。在此基础上,采用干扰素α雾化吸入,每次500万IU,加入灭菌注射用水2ml,每日2次。 

Description for medicine or protocol of treatment in detail:

Experimental group: The baseline antiviral treatment drug was used with 2 capsules of lopinavir / ritonavir (Coriolus, 200mg / 50mg), twice a day, and the course of treatment was no more than 10 days. If the drug had serious adverse reactions, the drug could be stopped at any time. On this basis, inhaled with rSIFN-co; Control group: The baseline antiviral treatment drug was used with 2 capsules of lopinavir / ritonavir (Coriolus, 200mg / 50mg), twice a day, and the course of treatment was no more than 10 days. If the drug had serious adverse reactions, the drug could be stopped at any time. On this basis, inhaled with interferon-α. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)年龄>18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)确诊为新型冠状病毒肺炎的普通型或者重型患者。普通型患者定义为即具有发热和/或呼吸道症状,且胸部CT可见肺炎表现。重型患者定义为复合下列任何一条: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. Age over 18 years old; 2. Real-time fluorescent RT-PCR for respiratory or blood specimens to detect novel coronavirus nucleic acid positive; 3. The sequence of virus genes in respiratory or blood samples was highly homologous with the known novel coronavirus; 4. A common or severe type of new type of coronavirus pneumonia was diagnosed. The common patients diagnosed with novel coronavirus pneumonia that have fever, respiratory symptoms, and imaging shows pneumonia. Some severe patients could be included. Accord with any of the following: (1) Respiratory distress, RR >= 30 times / minute; (2) In resting state, means oxygen saturation <= 93%; (3) Arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <=300mmHg. 

排除标准:

(1)妊娠或哺乳期妇女; (2)无法进行雾化吸入的患者; (3)对干扰素或其制剂不耐受或过敏者; (4)经研究者判断患者不适宜纳入试验。 

Exclusion criteria:

1. Pregnant or lactating women; 2. Patients who cannot be inhaled by atomization; 3. Patients who are intolerant or allergic to interferon preparations; 4. Other patients were judged unsuitable for inclusion in the trial by researchers. 

研究实施时间:

Study execute time:

From2020-02-10To 2020-08-01 

干预措施:

Interventions:

组别:

试验组

样本量:

50

Group:

Treatment group

Sample size:

干预措施:

基线抗病毒治疗(洛匹那韦/利托那韦或阿比多尔)+新型基因重组高效复合干扰素雾化吸入

干预措施代码:

Intervention:

baseline antiviral treatment (lopinavir / ritonavir or abidol) and inhaled with rSIFN-co

Intervention code:

组别:

对照组

样本量:

50

Group:

Control group

Sample size:

干预措施:

基线抗病毒治疗(洛匹那韦/利托那韦或阿比多尔)+干扰素α雾化吸入

干预措施代码:

Intervention:

baseline antiviral treatment (lopinavir / ritonavir or abidol) and inhaled with interferon-α

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三甲 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

成都市公共卫生临床医疗中心 

单位级别:

三甲 

Institution
hospital:

Chengdu Public Health Clinical Medical Center  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

武汉红十字会医院 

单位级别:

二乙 

Institution
hospital:

Wuhan Red Cross Hospital  

Level of the institution:

Secondary B 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

西南医科大学附属医院 

单位级别:

三甲 

Institution
hospital:

The Affiliated Hospital of Southwest Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

湖北省妇幼保健院光谷院区 

单位级别:

三甲 

Institution
hospital:

Guanggu District, the Maternal and Child Health Hospital of Hubei Province  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

绵阳市中心医院 

单位级别:

三甲 

Institution
hospital:

Mianyang Central Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

disease remission

指标类型:

主要指标 

Outcome:

疾病缓解

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床缓解时间

指标类型:

主要指标 

Outcome:

time to clinical improvement

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第7天,第14天,第28天临床缓解率

指标类型:

主要指标 

Outcome:

overall rates of clinical improvement assessed at days 7, 14, and 28

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胸部CT炎症吸收时间

指标类型:

主要指标 

Outcome:

time to chest CT improvement

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病毒核酸转阴时间

指标类型:

主要指标 

Outcome:

time to virus nucleic acid negative-conversion

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第7天,14天,28天影像学炎症缓解率

指标类型:

主要指标 

Outcome:

overall rates of radiological improvement on days 7, 14, and 28

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第7天,14天,28天病毒核酸转阴率

指标类型:

主要指标 

Outcome:

overall rates of virus nucleic acid negative-conversion on qRT-PCR in nasopharyngeal swabs samples on days 7, 14, and 28

Type:

Primary 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

指标类型:

次要指标 

Outcome:

time to discharge

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

死亡率

指标类型:

次要指标 

Outcome:

mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

恶化率

指标类型:

次要指标 

Outcome:

deterioration 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:

不良事件

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:

严重不良事件

指标类型:

主要指标 

Outcome:

serious adverse events

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:

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:

标本中文名:

下呼吸道分泌物

组织:

Sample Name:

Secretion of lower respiratory tract

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:

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:

其他

组织:

Sample Name:

Others

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):

每个中心入组的受试者均有随机编码入组试验组或者对照组。

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

The drugs were randomly coded.Each hospital enrolled subject was randomly coded into either the experimental or control group.

盲法:

单盲

Blinding:

Single blind

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):

可通过邮件联系项目负责人,进行数据获取

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

Data can be obtained by contacting the PI through email.

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:

数据以Excel 格式保存

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

data stored as Excel files

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-02-08
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