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A randomized, open label, parallel controlled trial of evaluating the efficacy of recombinant cytokine gene-derived protein injection for clearing novel coronavirus in patients with novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000029496 

最近更新日期:

Date of Last Refreshed on:

2020-03-22 

注册时间:

Date of Registration:

2020-02-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项评价重组细胞因子基因衍生蛋白注射液清除新型冠状病毒(COVID-19)的随机、开放、平行对照研究 

Public title:

A randomized, open label, parallel controlled trial of evaluating the efficacy of recombinant cytokine gene-derived protein injection for clearing novel coronavirus in patients with novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一项评价重组细胞因子基因衍生蛋白注射液清除新型冠状病毒(COVID-19)的随机、开放、平行对照研究 

Scientific title:

A randomized, open label, parallel controlled trial for evaluating the efficacy of recombinant cytokine gene-derived protein injection on clearing novel coronavirus in patients with 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:

 

申请注册联系人:

周灿平 

研究负责人:

龚国忠 

Applicant:

Zhou Canping 

Study leader:

Gong Guozhong 

申请注册联系人电话:

Applicant telephone:

+86 17775787897 

研究负责人电话:

Study leader's telephone:

+86 13873104819 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+86 0731-8592173 

申请注册联系人电子邮件:

Applicant E-mail:

zcp7025@163.com 

研究负责人电子邮件:

Study leader's E-mail:

gongguozhong@csu.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:

湖南省长沙市雨花区环保中路169号创合工业园G栋3楼 

研究负责人通讯地址:

长沙市芙蓉区人民中路139号 

Applicant address:

3 / F, Building G, Chuanghe Industrial Park, 169 Environmental Protection Middle Road, Yuhua District, Changsha, Hu'nan, China 

Study leader's address:

139 Renmin Road, Furong District, Changsha, Hu'nan, 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:

湖南海药鸿星堂医药有限公司 

Applicant's institution:

Hu'nan Haiyao hongxingtang 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:

KX2020-002; 2020-003 

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:

中南大学湘雅二医院医学伦理委员会/长沙市第一医院医学伦理委员会 

Name of the ethic committee:

The Second Xiangya Hospital of Central South University Ethics Committee / Medical Ethics Committee of Changsha 1st Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-10 

伦理委员会联系人:

中南大学湘雅二医院医学伦理委员会 

Contact Name of the ethic committee:

The Second Xiangya Hospital of Central South University Ethics Committee 

伦理委员会联系地址:

长沙市芙蓉区人民中路139号 

Contact Address of the ethic committee:

139 Renmin Road, Furong District, Changsha, Hu'nan, 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:

长沙市第一医院;中南大学湘雅二医院 

Primary sponsor:

The First Hospital of Changsha; The Second Xiangya Hospital of Central South University 

研究实施负责(组长)单位地址:

长沙市开福区营盘路311号; 长沙市芙蓉区人民中路139号 

Primary sponsor's address:

311 Yingpan Road, Kaifu District, Changsha; 139 Renmin Road, Furong District, Changsha, Hu'nan, 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):

湖南

市(区县):

长沙

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

长沙市第一医院

具体地址:

开福区营盘路311号

Institution
hospital:

The First Hospital of Changsha

Address:

311 Yingpan Road, Kaifu District

国家:

中国

省(直辖市):

湖南

市(区县):

长沙

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

中南大学湘雅二医院

具体地址:

芙蓉区人民中路139号

Institution
hospital:

The Second Xiangya Hospital of Cental South University

Address:

139 Renmin Road, Furong District

经费或物资来源:

自筹及申请科研经费 

Source(s) of funding:

Self financing and application for scientific research funds 

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:

评价重组细胞因子基因衍生蛋白注射液(乐复能)、洛匹那韦/利托那韦片(克力芝)治疗新型冠状病毒感染的成人住院患者的疗效和安全性。 

Objectives of Study:

To evaluate the efficacy and safety of recombinant cytokine gene-derived protein injection (Novaferon) and lopinavir / ritonavir tablets(Kaletra) in the treatment of adult inpatients with new coronavirus infection. 

药物成份或治疗方案详述:

重组细胞因子基因衍生蛋白注射液,已上市的抗病毒新蛋白; 洛匹那韦/利托那韦片,lopinavir / ritonavir tablets,治疗HIV的蛋白酶的抑制剂,复方制剂 

Description for medicine or protocol of treatment in detail:

Recombinant cytokine gene-derived protein injection (Novaferon), novel antiviral protein with high potent activity lopinavir / ritonavir tablets,a protease inhibitor combination. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)年龄,18≤年龄≤70周岁; (2)经过病源学证实的新型冠状病毒感染的轻、重型患者。 

Inclusion criteria

(1) aged 18 to 70 years; (2) Light and heavy patients with new coronavirus infection confirmed by etiology. 

排除标准:

(1)任何不能让方案安全进行的情况; (2)过敏体质; (3)影响生存的严重基础疾病,包括:未控制已经多处转移不能切除的恶性肿瘤、血液病、恶液质、活动性出血、严重营养不良、 HIV等; 主要脏器功能异常 (4)肝功能明显异常:谷丙转氨酶 (ALT)/谷草转氨酶(AST)升高超过正常上限 5 倍,总胆红素升高超过正常上限 2 倍; (5)肺部肿瘤致阻塞性肺炎、严重肺间质纤维化、肺泡蛋白沉积症、过敏性肺泡炎者 (6)妊娠:育龄女性妊娠试验阳性; (7)患者可能在 72h 内转至非参与医院; (8)近 6个月内持续使用免疫抑制剂,或器官移植者; (9)体外生命支持患者(ECMO、 ECCO2R、 RRT); (10)预计48小时内死亡者; 

Exclusion criteria:

(1) any situation in which the program cannot proceed safely; (2) allergic constitution; (3) serious basic diseases affecting survival, including uncontrolled malignant tumors with multiple metastases that cannot be resected, blood diseases, malignant fluid, active bleeding, severe malnutrition, HIV, etc.; The main organ function is abnormal (4) liver function was obviously abnormal: ALT/AST increased by more than 5 times the normal upper limit, increase of total bilirubin more than 2 times of normal upper limit; (5) obstructive pneumonia, severe pulmonary fibrosis, alveolar proteinosis and allergic alveolitis caused by lung tumors; (6) pregnancy: positive pregnancy test for women of child-bearing age; (7) the patient may be transferred to a non-participating hospital within 72h; (8) continuous use of immunosuppressants or organ transplants within the past 6 months; (9) in vitro life support patients (ECMO, ECCO2R, RRT); (10) expected survival no more than 48 hours. 

研究实施时间:

Study execute time:

From2020-01-29To 2021-01-29 

干预措施:

Interventions:

组别:

干预组A

样本量:

30

Group:

Intervention A

Sample size:

干预措施:

内科常规治疗的基础上给予乐复能雾化组,20μg/次;一天二次,7-14天。

干预措施代码:

Intervention:

On the basis of routine medical treatment, the patients were given Novaferon Atomization inhalation, 20ug each time, twice a day, 7-14 days.

Intervention code:

组别:

干预组B

样本量:

30

Group:

intervention B

Sample size:

干预措施:

内科常规治疗的基础上给予洛匹那韦/利托那韦片(克力芝),一日2次,一次2片,7-14天

干预措施代码:

Intervention:

On the basis of routine medical treatment, the patients were given lopinavir / ritonavir tablets (Kaletra) twice a day, twice each time, 7-14 days.

Intervention code:

组别:

干预组C

样本量:

30

Group:

intervention C

Sample size:

干预措施:

内科常规治疗的基础上联合乐复能和克力芝,用法和疗程同上。

干预措施代码:

Intervention:

On the basis of routine medical treatment, combined with Novafron and Kaletra, the usage and course of treatment are the same as above.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hu'nan 

City:

Changsha 

单位(医院):

长沙市第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Hospital of Changsha  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hu'nan 

City:

Changsha 

单位(医院):

中南大学湘雅二医院 

单位级别:

三甲医院 

Institution
hospital:

The Second Xiangya Hospital of Cental South University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

新型冠状病毒核酸转阴率

指标类型:

主要指标 

Outcome:

novel coronavirus nucleic acid clearance rate

Type:

Primary indicator 

测量时间点:

治疗6天后

测量方法:

RT-PCR

Measure time point of outcome:

on day 6 after treatment

Measure method:

RT-PCR

指标中文名:

新型冠状病毒核酸转阴时间

指标类型:

次要指标 

Outcome:

time till the SARS-CoV-2 clearance

Type:

Secondary indicator 

测量时间点:

用药后3天、6天、9天等

测量方法:

RT-PCR

Measure time point of outcome:

on day 3, day 6, day 9, et al

Measure method:

RT-PCR

指标中文名:

不良反应率

指标类型:

副作用指标 

Outcome:

Adverse reaction rate

Type:

Adverse events 

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:

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:

粪便(有条件可做)

组织:

Sample Name:

Feces (if possible)

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 70 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):

由统计师用SAS软件生成随机分配表,研究者根据受试者筛选成功的先后顺序获取随机号。

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

The statistician uses SAS software to generate the random assignment table, and the researcher obtains the random number according to the sequence of successful screening of the subjects.

盲法:

未说明

Blinding:

Not stated

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):

研究结果公开发表后,基于研究目的、并得到伦理委员会同意,可向主要研究者发邮件索取原始数据。

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

after publication of trial results, any researcher could send an email to PI for original data with the purpose of study and approval of Ethics Committee。

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:

填写纸质CRF表

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

Fill in the paper CRF form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-03
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