Today is 2020-11-25

The efficacy and safety of Triazavirin for 2019 novel coronary pneumonia (COVID-19): a multicenter, randomized, double blinded, placebo-controlled trial
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注册号:

Registration number:

ChiCTR2000030001 

最近更新日期:

Date of Last Refreshed on:

2020-06-17 

注册时间:

Date of Registration:

2020-02-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

特力阿扎维林治疗2019新型冠状病毒肺炎(COVID-19)患者有效性和安全性的多中心、随机、双盲、安慰剂对照临床研究 

Public title:

The efficacy and safety of Triazavirin for 2019 novel coronary pneumonia (COVID-19): a multicenter, randomized, double blinded, placebo-controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

特力阿扎维林治疗2019新型冠状病毒肺炎(COVID-19)患者有效性和安全性的多中心、随机、双盲、安慰剂对照临床研究 

Scientific title:

The efficacy and safety of Triazavirin for 2019 novel coronary pneumonia (COVID-19): a multicenter, randomized, double blinded, placebo-controlled trial 

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:

吴效科 

研究负责人:

杨宝峰 

Applicant:

Xiaoke Wu 

Study leader:

Baofeng Yang 

申请注册联系人电话:

Applicant telephone:

+86 13796025599 

研究负责人电话:

Study leader's telephone:

+86 133 0451 2381 

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:

xiaokewu2002@vip.sina.com 

研究负责人电子邮件:

Study leader's E-mail:

yangbf@ems.hrbmu.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:

黑龙江省哈尔滨市香坊区中山路82号 

研究负责人通讯地址:

黑龙江省哈尔滨市南岗区学府路194号 

Applicant address:

82 Zhongshan Road, Xiangfang District, Harbin, Heilongjiang, China 

Study leader's address:

194 Xuefu Road, Nangang District, Harbin, Heilongjiang, 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:

黑龙江省医院 

Applicant's institution:

Heilongjiang Province 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:

003JJ02 

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:

黑龙江省医院伦理委员会 

Name of the ethic committee:

Ethics committee of Heilongjiang Provincial hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-13 

伦理委员会联系人:

任绪 

Contact Name of the ethic committee:

Ren Xu 

伦理委员会联系地址:

黑龙江省哈尔滨市香坊区中山路82号 

Contact Address of the ethic committee:

82 Zhongshan Road, Xiangfang District, Harbin, Heilongjiang, 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:

黑龙江省卫生健康委员会 

Primary sponsor:

Health commission of Heilongjiang province 

研究实施负责(组长)单位地址:

黑龙江省哈尔滨市香坊区赣水路36号 

Primary sponsor's address:

36 Ganshui Road, Xiangfang District, Harbin, Heilongjiang, 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):

黑龙江

市(区县):

Country:

China

Province:

Heilongjiang

City:

单位(医院):

黑龙江省卫生健康委员会

具体地址:

黑龙江省哈尔滨市香坊区赣水路36号

Institution
hospital:

Health commission of Heilongjiang province

Address:

36 Ganshui Road, Xiangfang District, Harbin

经费或物资来源:

黑龙江省卫生健康委员会 

Source(s) of funding:

Health commission of Heilongjiang province 

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:

III期临床试验 

Study phase:

研究目的:

评价特力阿扎维林治疗成人新冠肺炎住院患者的有效性及安全性。 

Objectives of Study:

To evaluate the efficacy and safety of Triazavirin in the treatment of adult hospitalized patients with 2019 novel coronary 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)成人(定义为年龄≥18岁)理解并同意签署知情同意书; (2)经过实验室RT-PCR确诊的新型冠状病毒感染患者; (3)胸部影像检查(CT)证实肺部受累:肺部多发小斑片影及间质改变,以肺外带明显,或双肺多发磨玻璃影、浸润影,轻型患者可能没有该表现; (4)住院患者,伴有发热(腋温≥37.0°C)或呼吸道症状; (5)症状发作与随机入组之间的时间间隔在12天以内; (6)3个月内未参加其他临床研究者; (7)随访的28天内不再参与其他抗病毒药物研究。 

Inclusion criteria

(1) Adult aged >=18 years and agrees to sign the informed consent; (2) Laboratory-confirmed 2019-nCoV infection by real-time RT-PCR; (3) Chest imaging (CT) confirmed lung damage: multiple small plaques and stromal changes in the lungs, which were obvious in the outer lung, or multiple ground-glass shadows and infiltration shadows in both lungs, the changes may not be present in mild patients; (4) Hospitalized patients with fever (axillary temperature >=37.0 degree C) or respiratory symptoms; (5) The interval between symptom onset and randomization was within 12 days; (6) Did not participate in other clinical researches within 3 months; (7) Do not participate other antiviral studies within 28 days of follow-up. 

排除标准:

(1)经治医生认为患者不适宜参加本研究或者参加本研究可能使患者处于不安全的情况; (2)既往有严重的肝脏疾病,按照Child-Pugh分级属于C级; (3)既往有重度肾功能受损(肾小球滤过率≤30mL/min/1.73m2)或既往接受连续肾脏代替治疗、血液透析或腹膜透析的患者; (4)重度贫血患者,Hgb<60g/L。 (5)妊娠、育龄女性妊娠试验阳性或哺乳期女性; (6)既往有特力阿扎维林或组分过敏史者; (7)未签署知情同意; (8)患者可能在72h内转至非参与本研究医院; (9)在筛查前30天内接受了任何治疗新型冠状病毒感染的试验性治疗。 

Exclusion criteria:

(1) The PI considers that the patient is not suitable to participate the study or the patient may be unsafe if he participate the study; (2) Patients with serious liver disease, grade C according to child-pugh; (3) Patients with severe renal impairment (glomerular filtration rate <=30mL/min/1.73m2) or who have received continuous renal replacement therapy, hemodialysis or peritoneal dialysis; (4) Patients with severe anemia, Hgb < 60g/L. (5) Pregnant women or women with pregnancy test positive or breastfeeding women; (6) Patients with allergy history of Triazavirin or its components; (7) Confused to sign the informed consent; (8) Patients may be transferred to another hospital within 72h; (9) Received any experimental treatment for novel coronavirus infection within 30 days prior to screening. 

研究实施时间:

Study execute time:

From2020-02-15To 2020-05-28 

征募观察对象时间:

Recruiting time:

From2020-02-15To 2020-04-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

120

Group:

Experimental group

Sample size:

干预措施:

基础治疗联合特力阿扎维林

干预措施代码:

Intervention:

Basic treatment combined Triazavirin

Intervention code:

组别:

对照组

样本量:

120

Group:

Control group

Sample size:

干预措施:

基础治疗联合特力阿扎维林安慰剂

干预措施代码:

Intervention:

Basic treatment combined Triazavirin placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

哈尔滨医科大学附属第一医院 

单位级别:

三级甲等医院 

Institution
hospital:

The first affiliated hospital of Harbin medical university  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

哈尔滨医科大学附属第二医院 

单位级别:

三级甲等医院 

Institution
hospital:

The second affiliated hospital of Harbin medical university  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

哈尔滨医科大学附属第四医院 

单位级别:

三级甲等医院 

Institution
hospital:

The fourth affiliated hospital of Harbin medical university  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

黑龙江省医院 

单位级别:

三级甲等医院 

Institution
hospital:

Heilongjiang Provincial hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

临床改善时间

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:

退热时间

指标类型:

次要指标 

Outcome:

Antifebrile time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部CT炎症吸收程度

指标类型:

次要指标 

Outcome:

Inflammatory absorption of 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:

核酸检测转阴时间

指标类型:

次要指标 

Outcome:

Intervals from positive to negative of Nucleic acid test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病死率

指标类型:

次要指标 

Outcome:

Mortality 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:

重症转换率

指标类型:

次要指标 

Outcome:

conversion rate of severe patients

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:

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 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):

由哈尔滨医科大学统计学教研室李康教授产生随机序列

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

Professor Li kang, Department of statistics, The first affiliated hospital of Harbin medical university, generates the random number sequence.

盲法:

双盲

Blinding:

Double blinding

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

数据待录入,将录入在medresman平台

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

The data will be put into medresman.

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:

数据采集和管理采用纸质版CRF与电子采集和管理系统同时进行。电子数据采集平台采用ResMan系统。

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

Data collection and management are carried out by paper CRF and electronic data collection and management system. ResMan system is adopted in electronic data collection.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-19
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