Today is 2022-05-24

A randomized, open-label, blank-controlled, multicenter trial for Polyinosinic-Polycytidylic Acid Injection in the treatment of novel coronavirus pneumonia (COVID-19)
download

注册号:

Registration number:

ChiCTR2000029776 

最近更新日期:

Date of Last Refreshed on:

2020-02-13 

注册时间:

Date of Registration:

2020-02-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

聚肌胞注射液治疗新型冠状病毒肺炎 (COVID-19)有效性和安全性的随机、开放、平行对照、多中心临床试验 

Public title:

A randomized, open-label, blank-controlled, multicenter trial for Polyinosinic-Polycytidylic Acid Injection 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:

聚肌胞注射液治疗新型冠状病毒肺炎(COVID-19)有效性和安全性的随机、开放、平行对照、多中心临床试验 

Scientific title:

A randomized, open-label, blank-controlled, multicenter trial for Polyinosinic-Polycytidylic Acid Injection 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:

 

申请注册联系人:

吴佩亮 

研究负责人:

黄晓颖 

Applicant:

Peiliang Wu 

Study leader:

Xiaoyin Huang 

申请注册联系人电话:

Applicant telephone:

+86 13587699620 

研究负责人电话:

Study leader's telephone:

+86 13819711719 

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:

404350351@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zjwzhxy@126.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:

浙江省温州市瓯海区南白象 

研究负责人通讯地址:

浙江省温州市瓯海区南白象 

Applicant address:

Nanbaixiang, Ouhai District, Wenzhou, Zhejiang 

Study leader's address:

Nanbaixiang, Ouhai District, Wenzhou, Zhejiang 

申请注册联系人邮政编码:

Applicant postcode:

325000 

研究负责人邮政编码:

Study leader's postcode:

325000 

申请人所在单位:

温州医科大学附属第一医院 

Applicant's institution:

The First Affiliated of Wenzhou Medical 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第(001)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:

温州医科大学附属第一医院临床研究专业伦理委员会 

Name of the ethic committee:

Ethics Committee in Clinical Research of the First Affiliated of Wenzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-11 

伦理委员会联系人:

金嵘 

Contact Name of the ethic committee:

Jin Rong 

伦理委员会联系地址:

浙江省温州市瓯海区南白象 

Contact Address of the ethic committee:

Nanbaixiang, Ouhai District, Wenzhou, Zhejiang 

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:

温州医科大学附属第一医院 

Primary sponsor:

The First Affiliated of Wenzhou Medical University 

研究实施负责(组长)单位地址:

浙江省温州市瓯海区南白象 

Primary sponsor's address:

Nanbaixiang, Ouhai District, Wenzhou, Zhejiang 

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):

温州

Country:

China

Province:

Zhejiang

City:

Wenzhou

单位(医院):

温州医科大学附属第二医院

具体地址:

学院西路109号

Institution
hospital:

The Second Affiliated of Wenzhou Medical University

Address:

109 Xueyuan Road West

经费或物资来源:

自筹资金 

Source(s) of funding:

self-raised 

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:

价聚肌胞注射液治疗新型冠状病毒感染的肺炎的临床疗效和安全性。 

Objectives of Study:

To evaluate the clinical efficacy and safety of Polyinosinic-polycytidylic Acid Injection in the treatment of Novel coronavirus pneumonia. 

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) 符合《新型冠状病毒感染的肺炎诊疗方案(试行第五版或更新版本)》确诊的新型冠状病毒感染的肺炎患者; (2) 年龄在18周岁以上(包括18周岁)的住院患者,性别不限; (3) 知情同意并自愿参加本项临床试验,签署知情同意书者。 

Inclusion criteria

1. Patients with confirmed new coronavirus-infected pneumonia; 2. Above 18 years old (inclusive); 3. Voluntarily sign written informed consent.  

排除标准:

(1) 重症肺炎需要机械通气、危重型新型冠状病毒感染肺炎患者; (2) 预计48小时内死亡者; (3) 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、肺发育异常等基础疾病引起的呼吸道感染; (4) 胸部CT证实存在严重的肺间质病变等基础性肺部疾病患者; (5) 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,严重的营养不良等;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; (6) 精神状态不能合作者,患有精神性疾病、不能自制、不能明确表达者; (7) 过敏体质(如对两种或以上药物、食物过敏者)或对本品及常规治疗药物等有过敏史者; (8) 有药物滥用或依赖史; (9) 妊娠或哺乳期妇女; (10) 近3个月内参加过其他药物临床试验者; 

Exclusion criteria:

1. Severe pneumonia requires mechanical ventilationcritically severe cases; 2. Estimated Time of Death is less than 48 hours; 3. 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; 4. 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; 5. 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.; 6. Mental state unable to cooperate, suffering from mental illness, unable to control, unable to express clearly 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. Patients with a history of substance abuse or dependence; 9. Pregnant or lactating women; 10. Patients who participated in other clinical trials within the last 3 months; 11. 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:

From2020-02-11To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2020-02-11To 2020-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

20

Group:

experimental group

Sample size:

干预措施:

聚肌胞注射液联合常规治疗

干预措施代码:

Intervention:

Polyinosinic-Polycytidylic Acid Injection and conventional therapy

Intervention code:

组别:

对照组

样本量:

20

Group:

control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

conventional therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

温州 

Country:

China 

Province:

zhejiang 

City:

Wenzhou 

单位(医院):

温州医科大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated of Wenzhou Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

浙江 

市(区县):

温州 

Country:

China 

Province:

Zhejiang 

City:

Wenzhou 

单位(医院):

温州医科大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated of Wenzhou Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

疾病痊愈时间

指标类型:

主要指标 

Outcome:

Time to Clinical recovery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病毒转阴时间及转阴率

指标类型:

次要指标 

Outcome:

Virus negative time and negative 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:

主要症状(发热、乏力、咳嗽)消失时间及消失率

指标类型:

次要指标 

Outcome:

Time and rate of disappearance of main symptoms (fever, fatigue, cough)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病情加重(转入RICU)时间

指标类型:

次要指标 

Outcome:

The time when the condition becomes worse (transfer to RICU)

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:

BRT

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血生化

指标类型:

次要指标 

Outcome:

Blood biochemistry

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:

静脉血

Sample Name:

blood samples

Tissue:

Venous blood

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:

咽部

Sample Name:

Pharyngeal swab

Tissue:

Pharyngeal

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):

研究者通过计算机产生随机数对所有新型冠状病毒肺炎随机分为A组和B组,研究者及受试者均不可选择分组。

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

All patients with Novel coronavirus pneumonia were randomly divided into group A and group B by computers, and both the investigators and the subjects were not allowed to group.

盲法:

open label

Blinding:

open label

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

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):

本课题组于本临床试验所获原始数据将于本试验结束后6个月在中国临床试验注册中心(http://www.chictr.org.cn/edit.aspx?pid=49342&htm=4)进行共享。

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

The original data obtained in this clinical trial will be shared at 6 months after the end of this trial at the China Clinical Trials Registry (http://www.chictr.org.cn/edit.aspx?pid=49342&htm=4).

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:

病例报告表由试验协调员与试验管理小组一起设计。所有电子患者身份信息将在一个安全的,受密码保护的数据库上进行,只能由基本人员访问。 具有患者识别信息的纸张形式将在温州医科大学附属第一医院限制区内的安全锁定的文件柜中进行。患者只能由代码号识别。 直接访问源数据/文件将需要与试用有关的监控。所有纸张和电子数据将在试验完成后至少保留五年。

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

The case report form is designed by the test coordinator and the test management team. All electronic patient identity information will be conducted on a secure, password-protected database and can only be accessed by the basic person. Paper forms with patient identification information will be carried out in a securely locked cabinet in The first affiliated of Wenzhou Medical University. The patient can only be identified by the code number. Direct access to source data / files will require trial-related monitoring. All paper and electronic data will remain for at least five years after the test is completed.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-13
return list