Today is 2020-09-23

A randomized, open-label, controlled clinical trial for azvudine in the treatment of novel coronavirus pneumonia (COVID-19)
download

注册号:

Registration number:

ChiCTR2000029853 

最近更新日期:

Date of Last Refreshed on:

2020-02-16 

注册时间:

Date of Registration:

2020-02-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

阿兹夫定片治疗新型冠状病毒感染肺炎(COVID-19)的随机、开放、对照临床试验 

Public title:

A randomized, open-label, controlled clinical trial for azvudine 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:

阿兹夫定片治疗新型冠状病毒感染肺炎(COVID-19)的随机、开放、对照临床试验 

Scientific title:

A randomized, open-label, controlled clinical trial for azvudine 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:

裴广忠 

研究负责人:

裴广忠 

Applicant:

Pei Guangzhong 

Study leader:

Pei Guangzhong 

申请注册联系人电话:

Applicant telephone:

+86 13837908181 

研究负责人电话:

Study leader's telephone:

+86 13839708181 

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:

casebox365@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

503818505@qq.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:

河南省光山县正大街222号 

研究负责人通讯地址:

河南省光山县正大街222号 

Applicant address:

222 Zhengda Street, Guangshan County, He'nan, China 

Study leader's address:

222 Zhengda Street, Guangshan County, He'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:

光山县人民医院 

Applicant's institution:

People's Hospital of Guangshan County 

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:

光伦字[2020]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:

光山县人民医院医学伦理委员会 

Name of the ethic committee:

People's Hospital of Guangshan County EMC 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-15 

伦理委员会联系人:

任志刚 

Contact Name of the ethic committee:

Ren Zhigang 

伦理委员会联系地址:

河南省信阳市光山县正大街222号 

Contact Address of the ethic committee:

222 Zhengda Street, Guangshan County, Xinyang, He'nan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 18703636245 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

fccrenzg@zzu.edu.cn 

研究实施负责(组长)单位:

光山县人民医院 

Primary sponsor:

People's Hospital of Guangshan County 

研究实施负责(组长)单位地址:

河南省信阳市光山县正大街222号 

Primary sponsor's address:

222 Zhengda Street, Guangshan County, Xinyang, He'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):

河南省

市(区县):

光山县

Country:

China

Province:

He'nan

City:

Guangshan county

单位(医院):

光山县人民医院

具体地址:

河南省信阳市光山县正大街222号

Institution
hospital:

People's Hospital of Guangshan County

Address:

222 Zhengda Street, Guangshan County, Xinyang

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

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:

探索性研究/预试验 

Study phase:

研究目的:

在临床常规治疗的基础上,评价阿兹夫定片治疗新型冠状病毒感染肺炎的有效性和安全性 

Objectives of Study:

To evaluate the efficacy and safety of Azvudine in the treatment of COVID-19 with conventional treatment 

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) 年龄≥18周岁(含临界值),性别不限; (2) 呼吸道标本或血液标本实时荧光RT-PCR检测2019-nCoV核酸阳性,或者,呼吸道标本或血液标本病毒基因测序,与已知的2019-nCoV高度同源; (3) 确诊为新型冠状病毒感染者,患者符合世界卫生组织(WHO)在2020年1月28日发布的《最新版针对新型冠状病毒的临床指南》和中国卫健委《关于印发新型冠状病毒感染的肺炎诊疗方案(试行第五版)》的诊断标准; (4) 已签署知情同意书。 

Inclusion criteria

(1) aged >=18 years old; (2) real-time fluorescence rt-pcr of respiratory or blood samples presents the positive nucleic acid of COVID-19, or the viral gene sequencing of respiratory or blood samples was highly homologous with the known COVID-19. (3) patients diagnosed with novel coronavirus meet the diagnostic criteria of the latest clinical guidelines for novel coronavirus issued by the world health organization (WHO) on January 28, 2020 and the diagnostic criteria of the pneumonia diagnosis and treatment program for novel coronavirus infection (trial version 5) issued by National Health commission of the People's Republic of China. 

排除标准:

(1) 已知或怀疑对阿兹夫定片的组成成分过敏; (2) 合并有吸收障碍综合征,或其它任何对胃肠道吸收产生影响的状况,需要静脉营养或不能口服药物的患者; (3) 正在接受抗HIV病毒治疗的患者; (4) 患者出现以下情况之一者:出现呼吸衰竭,且需要机械通气;出现休克;合并其他器官功能衰竭需ICU监护治疗; (5) 妊娠期、哺乳期妇女或在试验期间及结束6个月内有生育计划; (6) 给药前12周内参加过其它临床试验或者正在使用试验性药物; (7) 根据研究者的判断,具有不适合参加本试验的其它情况。 

Exclusion criteria:

(1) known or suspected allergy to the components of Azivudine tablets; (2) patients with malabsorption syndrome or any other condition that affects gastrointestinal absorption and requires intravenous nutrition or unable to take oral medication; (3) patients who is currently receiving anti-hiv treatment; (4) patients with one of the following conditions: respiratory failure and mechanical ventilation;Shock;Combined with other organ failure, intensive care unit(ICU) was needed. (5) women who are pregnant or breast-feeding or have a family planning plan during the trial period and within 6 months after the end of the trial; (6) participating in another clinical trials or using experimental drugs within 12 weeks prior to administration; (7) there are other conditions that are not suitable for participating in this experiment evaluated by the investigator. 

研究实施时间:

Study execute time:

From2020-02-16To 2020-04-16 

征募观察对象时间:

Recruiting time:

From2020-02-16To 2020-03-16 

干预措施:

Interventions:

组别:

试验组

样本量:

10

Group:

Experimental group

Sample size:

干预措施:

口服给予阿兹夫定片剂 每日一次,每次5片

干预措施代码:

Intervention:

Oral administration of 5 tablets of 1mg Azvudine tablets daily

Intervention code:

组别:

常规治疗

样本量:

10

Group:

Control group

Sample size:

干预措施:

参照中国卫健委《关于印发新型冠状病毒感染的肺炎诊疗方案(试行第五版)》,给予受试者相应的治疗措施

干预措施代码:

Intervention:

According to the "Pneumonia Diagnosis and Treatment Plan for New Coronavirus Infection (Trial Version 5)" issued by National Health Commission of People's Republic of China, the subjects were given corresponding treatment.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河南省 

市(区县):

光山县 

Country:

China 

Province:

He'nan 

City:

Guangshan county 

单位(医院):

光山县人民医院 

单位级别:

二甲 

Institution
hospital:

People's Hospital of Guangshan County  

Level of the institution:

Secondary A Hospital 

测量指标:

Outcomes:

指标中文名:

体温恢复正常的时间和比例

指标类型:

主要指标 

Outcome:

time and rate of temperature return to normal;

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸道症状及体征(肺部啰音、咳嗽、咯痰、咽痛等)改善的时间和比例

指标类型:

主要指标 

Outcome:

time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腹泻、肌痛、乏力等其他症状改善的时间和比例

指标类型:

主要指标 

Outcome:

time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部影像学改善的时间和比例

指标类型:

主要指标 

Outcome:

time and rate of pulmonary imaging 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:

COVID-19核酸转阴的时间和比例

指标类型:

主要指标 

Outcome:

time and rate of change to negative COVID-19 nucleic acid test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

氧合指数改善的时间和比例

指标类型:

主要指标 

Outcome:

time and rate of improvement of oxygenation measurement

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD4计数改善的时间和比例

指标类型:

主要指标 

Outcome:

improvement time and rate of CD4 count

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

轻型/普通型转重型比例,重型转危重型比例

指标类型:

主要指标 

Outcome:

rate of mild/modorate type to severe type, rate of severe type to critical type

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:

主要指标 

Outcome:

length of hospitalization

Type:

Primary 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:

主要指标 

Outcome:

mortality

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:

静脉血

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:

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):

本研究由随机表确定受试者接受试验组或对照组。 随机表应用SAS按1:1随机产生。每例筛选期检查合格的受试者获得随机号,根据预先制定的随机表随机分配进入试验组或对照组,并按照相应的治疗方案接受治疗。

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

In this study, subjects were randomly assigned to the experimental group or control group.The randomization table was randomly generated by SAS with a ratio of 1:1.The eligible subjects in each screening period were given a randomized number followed by randomly being assigned to the experimental group or contr

盲法:

未说明

Blinding:

Not stated

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):

公开数据的时间为试验完成后的6个月内,方式为:联系统计师

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

The time to disclose the data is within 6 months of the completion of the trial by: Contacting the statisticia

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(CRF)由纸质版与电子数据库录入两种方式组成,纸质版 CRF为无碳复写、一式二份,由研究者填写,电子CRF在纸质版填写后需及时录入。每个受试者的数据必须完成两种CRF的填写。监查员(CRA) 应定期现场监查CRF,保证纸质CRF与电子CRF一致性,发现的问题与研究者核实后由研究者修改签字。完成后的纸质版CRF由CRA和各分中心的主要研究者审核签字后,向数据管理单位提交。CRF提交后,由数据管理团队进行逻辑数据审核。如对数据有疑问,由数据管理员发出“电子数据质询”至CRA及研究者,并通过CRA向研究者发出询问,研究者应尽快解答并返回,数据管理员根据研究者的回答进行数据修改、确认。所有错误内容及修改结果应有记录并妥善保存。纸质CRF在研究者、CRA、数据管理员之间的传递应有专门的记录并妥善保存

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

The case report form (CRF) is composed of paper version and electronic database. The paper version CRF is carbon-free and duplicates, which is filled out by researchers. Electronic CRF should be entered in time after the paper version is filled out. The data for each subject must be filled in in two types of CRF. The inspector (CRA) shall regularly monitor the CRF, on the spot to ensure that the paper CRF is consistent with the electronic CRF, and the problems found shall be verified with the researcher and modified and signed by the researcher. The completed paper version of CRF is reviewed and signed by CRA and the main researchers of each sub-center, and the first joint is submitted to the data management unit. After the CRF is submitted, the logical data review is carried out by the data management team. If there is any doubt about the data, the data administrator will issue an "electronic data challenge" to CRA and the researcher, and send the inquiry to the researcher through CRA. The researcher should answer the question and return it as soon as possible. The data administrator modifies and confirms the data according to the researcher's answer. All errors and modification results should be recorded and properly preserved. The transfer of paper CRF between researchers, CRA and data administrators should be specially recorded and properly preserved.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-15
return list