今天是:2020-09-28 星期一

评价重组细胞因子基因衍生蛋白注射液联合标准治疗在新型冠状病毒感染患者中的有效性和安全性的多中心、随机、开放性、对照临床研究
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注册号:

Registration number:

ChiCTR2000029573 

最近更新日期:

Date of Last Refreshed on:

2020-03-22 

注册时间:

Date of Registration:

2020-02-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

评价重组细胞因子基因衍生蛋白注射液联合标准治疗在新型冠状病毒感染患者中的有效性和安全性的多中心、随机、开放性、对照临床研究 

Public title:

A multicenter, randomized, open, controlled clinical study to evaluate the efficacy and safety of recombinant cytokine gene-derived protein injection in combination with standard therapy in patients with novel coronavirus infection 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价重组细胞因子基因衍生蛋白注射液联合标准治疗在新型冠状病毒感染患者中的有效性和安全性的多中心、随机、开放性、对照临床研究 

Scientific title:

A multicenter, randomized, open, controlled clinical study to evaluate the efficacy and safety of recombinant cytokine gene-derived protein injection in combination with standard therapy in patients with novel coronavirus infection 

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:

黄建荣 

研究负责人:

李兰娟 

Applicant:

Jianrong Huang 

Study leader:

Li Lanjuan 

申请注册联系人电话:

Applicant telephone:

+86 13777453438 

研究负责人电话:

Study leader's telephone:

+86 13906514210 

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:

hzhuangchina@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

ljli@zju.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:

浙江省杭州市庆春路79号 

研究负责人通讯地址:

浙江省杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China 

Study leader's address:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Medical College of Zhejiang 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)IIT快审第(26)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:

浙江大学医学院附属第一医院临床研究伦理委员会IIT伦理审查小组 

Name of the ethic committee:

Clinical Research Ethics Committee of the First Affiliated Hospital of Medical College of Zhejiang University 

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:

厉有名 

Contact Name of the ethic committee:

Li Youmin 

伦理委员会联系地址:

浙江省杭州市庆春路79号 

Contact Address of the ethic committee:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Medical College of Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市庆春路79号浙江大学医学院附属第一医院 

Primary sponsor's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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):

浙江

市(区县):

杭州

Country:

China

Province:

zhejiang

City:

Hangzhou

单位(医院):

浙江大学附属第一医院

具体地址:

庆春路79号

Institution
hospital:

The First Affiliated Hospital of Medical College of Zhejiang University

Address:

79 Qingchun Road, Shangcheng District

经费或物资来源:

合作方 

Source(s) of funding:

coordinater 

研究疾病:

新型冠状病毒感染 

Target disease:

novel coronavirus 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:

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联合标准治疗在新型冠状病毒感染患者中的有效性和安全性 

Objectives of Study:

To evaluate the efficacy and safety of recombinant cytokine gene-derived protein injection in combination with standard therapy in patients with novel 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:

需满足以下所有标准才能入组: 1)确诊患者(或法律监护人)同意参加本研究并签署知情同意书; 2)18≤年龄≤65周岁,性别不限; 3)症状发作与随机入组之间的时间间隔在8天以内(症状发作主要以发热出现时间作为判定依据); 4)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患者; 5)根据《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》诊断为轻型、普通型或重型病例: A. 轻型:临床症状轻微,影像学未见肺炎表现; B. 普通型:具有发热、呼吸道等症状,影像学可见肺炎表现; C. 重型:符合下列任何一条: a. 呼吸窘迫,呼吸频率≥30次/分; b. 静息状态下,指氧饱和度(SaO2)≤93%; c. 动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg 

Inclusion criteria

o be enrolled, all the following criteria must be met: 1) the confirmed patient (or legal guardian) agrees to participate in the study and signs the informed consent; 2) Aged 18-65 years, gender not limited; 3) the time interval between symptom onset and random enrollment was within 8 days (symptom onset was mainly determined by the time of fever); 4) real-time fluorescence rt-pcr detection of respiratory tract or blood samples in patients with positive nucleic acid of novel coronavirus; 5) diagnosis of mild, common or severe cases according to the diagnosis and treatment plan for pneumonia caused by novel coronavirus (trial version 5): A. Mild: the clinical symptoms were mild, and no pneumonia was found on imaging; B. Common type: symptoms such as fever and respiratory tract, and manifestations of pneumonia can be seen on imaging; C. Heavy: meets any of the following: A. respiratory distress, respiratory frequency >= 30 times/min; B. At rest, oxygen saturation (SaO2) <= 93%; C. Arterial partial oxygen pressure (PaO2)/oxygen absorption concentration (FiO2) <= 300mmHg. 

排除标准:

满足以下任一一条标准则不能入组: 1) 任何不能让方案安全进行的情况; 2) 过敏体质,对一种及以上食物或药物过敏; 3) 伴有影响生存的严重基础疾病,包括未被控制的有临床意义的心脏、肺、肾脏、消化、血液病、神经精神疾病、免疫性疾病、代谢性疾病、恶性肿瘤、严重营养不良等; 4) 妊娠期或哺乳期妇女; 5) 患者可能在72h内转至非参与医院; 6) 近 6个月内持续使用免疫抑制剂,或器官移植者; 7) 根据《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》诊断的危重型患者; 8) 精神状态不能合作者,患有精神性疾病、无自制力、不能明确表达者; 9) 感染前患有HBV、HCV、TPPA、HIV、胰腺炎病史; 10) 正参加其它临床试验者。 

Exclusion criteria:

You cannot be enrolled if you meet any of the following criteria: 1) any situation that cannot allow the program to proceed safely; 2) allergic constitution, allergic to more than one kind of food or medicine; 3) patients with severe basic diseases that affect survival, including uncontrolled clinically significant heart, lung, kidney, digestion, blood diseases, neuropsychiatric diseases, immune diseases, metabolic diseases, malignant tumors, and severe malnutrition; 4) pregnant or lactating women; 5) patients may be transferred to non-participating hospitals within 72 hours; 6) patients who have been on immunosuppressive agents or organ transplants for nearly 6 months; 7) critically ill patients diagnosed according to the diagnosis and treatment plan for pneumonia caused by novel coronavirus infection (trial fifth edition); 8) those who are unable to cooperate in mental state, suffer from mental illness, have no self-control and cannot express clearly; 9) a history of HBV, HCV, TPPA, HIV and pancreatitis before infection; 10) participants in other clinical trials. 

研究实施时间:

Study execute time:

From2020-02-05To 2020-06-30 

征募观察对象时间:

Recruiting time:

From2020-02-06To 2020-04-30 

干预措施:

Interventions:

组别:

轻症组A

样本量:

80

Group:

Mild Type Group A

Sample size:

干预措施:

按照《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》(包括之后的更新版)中提及的抗病毒治疗及其他临床应用的抗病毒治疗(包括但不限于雾化吸入α-干扰素、口服洛匹那韦/利托那韦、静脉滴注利巴韦林等)和中药等治疗。

干预措施代码:

Intervention:

antiviral therapy and Chinese medicine treatment

Intervention code:

组别:

轻症组B

样本量:

80

Group:

Mild Type Group B

Sample size:

干预措施:

按照《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》(包括之后的更新版)中提及的抗病毒治疗及其他临床应用的抗病毒治疗(包括但不限于雾化吸入α-干扰素、口服洛匹那韦/利托那韦、静脉滴注利巴韦林等)和中药等治疗,同时,予以乐复能注射液20μg/次,雾化吸入,每日两次。

干预措施代码:

Intervention:

antiviral therapy, Chinese medicine treatment, and Novaferon atomization

Intervention code:

组别:

普通及重型组C

样本量:

160

Group:

Common and Heavy Type Group C

Sample size:

干预措施:

按照《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》(包括之后的更新版)中提及的抗病毒治疗及其他临床应用的抗病毒治疗(包括但不限于雾化吸入α-干扰素、口服洛匹那韦/利托那韦、静脉滴注利巴韦林等)和中药等治疗。

干预措施代码:

Intervention:

antiviral therapy and Chinese medicine treatment

Intervention code:

组别:

普通及重型组D

样本量:

160

Group:

Common and Heavy Type Group C

Sample size:

干预措施:

按照《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》(包括之后的更新版)中提及的抗病毒治疗及其他临床应用的抗病毒治疗(包括但不限于雾化吸入α-干扰素、口服洛匹那韦/利托那韦、静脉滴注利巴韦林等)和中药等治疗,同时,予以乐复能注射液20μg/次,雾化吸入,每日两次。

干预措施代码:

Intervention:

antiviral therapy, Chinese medicine treatment, and Novaferon atomization

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Medical College of Zhejiang University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

比较各治疗组间,受试者呼吸道标本或血液标本中新型冠状病毒RNA转阴所需时长 的差异

指标类型:

主要指标 

Outcome:

The time required for RNA Yin conversion of novel coronavirus in respiratory or blood specimens was compared between treatment groups The difference of

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

比较各治疗组间,平均临床恢复时间的差异

指标类型:

次要指标 

Outcome:

Differences in mean clinical recovery time between treatment groups were compared

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

比较各治疗组间,在治疗第 7 天时呼吸道标本或血液标本中新型冠状病毒 RNA 转阴的受试者比例

指标类型:

次要指标 

Outcome:

The proportion of subjects for the novel coronavirus RNA in respiratory or blood samples at day 7 of treatment was compared between treatment groups

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

比较各治疗组间,在治疗第 14 天时呼吸道标本或血液标本中新型冠状病毒 RNA 转阴的受试者比例

指标类型:

次要指标 

Outcome:

RNA negative ratio of subjects for The novel coronavirus in respiratory or blood samples at day 14 of treatment was compared between treatment groups

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

在轻型队列中,比较各治疗组间,在治疗第 7 天时进展为肺炎的受试者比例

指标类型:

次要指标 

Outcome:

In the light cohort, the proportion of subjects who progressed to pneumonia at day 7 of treatment was compared between treatment groups

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

在普通及重型队列中,比较各治疗组间,在治疗第 14 天时肺炎严重指数 (PSI)的差异,胸部影像学差异(胸部 CT)

指标类型:

次要指标 

Outcome:

Pneumonia severity index at day 14 of treatment was compared between treatment groups in the general and heavy cohort (PSI) differences, chest imaging differences (chest CT)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

在普通型受试者中,比较各治疗组间,在治疗第 14天时进展为重症肺炎的受试 者比例

指标类型:

次要指标 

Outcome:

In normal subjects,the ratio of subjects who progressed to severe pneumonia on day 14 of treatment were compared between treatment groups

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

在普通及重型队列中,比较各治疗组间,在治疗第 14天时进展为危重症肺炎的 受试者比例

指标类型:

次要指标 

Outcome:

In normal and heavy queues,the ration of Progression to critical pneumonia at day 14 of treatment were compared between treatment groups

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

比较各治疗组间,在第 28天及第 84 天时因病死亡的受试者比例

指标类型:

次要指标 

Outcome:

The proportion of subjects who died of illness at day 28 and day 84 were compared between treatment groups

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

使用后保存 

说明

Fate of sample:

Preservation 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):

在研究开始之前由一名统计员撰写随机化方案,并根据随机化方案使用SAS 9.4(或更新版本)统计软件完成受试者编号、随机表的制作,并导入交互式网络应答系统(IWRS)中。在受试者签署ICF后,系统根据筛选顺序向各受试者分配一个筛选编号,符合入选标准且不符合任何一项排除标准的受试者将由研究者或合格的指定人员通过各自的密码进入IWRS系统,完成受试者编号分配和研究药物编号分配的操作。根据随机化方案进行了随机的受试者如在研究过程中因不可预知的原因退出本研究,无论其是否使用研究药物,该受试者的受试者编号不能分配给其他受试者再次使用。随机接受试验药或对照药的受试者比例为1:1。

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

Prior to the study, a statistician wrote the randomization protocol and, according to the randomization protocol, used SAS 9.4 (or later) statistical software to complete the generation of subject Numbers, randomization tables, and imported into the interactive network response system (IWRS).After participants signed ICF s

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):

相关网站和文章

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

Related websites and articles

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:

EDC系统

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

EDC

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-02-05
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