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Cancelled by the investigator Randomized controlled trial for the efficacy of dihydroartemisinine piperaquine in the treatment of mild/common novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030082 

最近更新日期:

Date of Last Refreshed on:

2020-03-15 

注册时间:

Date of Registration:

2020-02-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

研究者撤消 双氢青蒿素哌喹治疗轻型/普通型新型冠状病毒肺炎(COVID-19)的临床疗效评价 

Public title:

Cancelled by the investigator Randomized controlled trial for the efficacy of dihydroartemisinine piperaquine in the treatment of mild/common novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

双氢青蒿素哌喹治疗轻型/普通型新型冠状病毒肺炎(COVID-19)的临床疗效评价 

Scientific title:

Randomized controlled trial for the efficacy of dihydroartemisinine piperaquine in the treatment of mild/common 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:

黄先豹 

研究负责人:

洪涛 

Applicant:

Huang Xianbao 

Study leader:

Hong tao 

申请注册联系人电话:

Applicant telephone:

+86 18679119505 

研究负责人电话:

Study leader's telephone:

+86 13803535961 

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:

huangxianbao2017@163.com 

研究负责人电子邮件:

Study leader's E-mail:

ht2000@vip.sina.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:

江西省南昌市东湖区永外正街17号 

研究负责人通讯地址:

江西省南昌市东湖区永外正街17号 

Applicant address:

17 Yongwai Main Street, Donghu District, Nanchang, Jiangxi, China 

Study leader's address:

17 Yongwai Main Street, Donghu District, Nanchang, Jiangxi, 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:

南昌大学第一附属医院 

Applicant's institution:

The First Affiliated Hospital of Nanchang 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:

ndyfy(2020)医研伦审第(40)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:

南昌大学第一附属医院医学研究化理委员会 

Name of the ethic committee:

Clinical Research Ethics Committee of the First Affiliated Hospital of Nanchang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-19 

伦理委员会联系人:

刘志礼 

Contact Name of the ethic committee:

Liu Zhili 

伦理委员会联系地址:

江西省南昌市东湖区永外正街17号 

Contact Address of the ethic committee:

17 Yongwai Main Street, Donghu District, Nanchang, Jiangxi, 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:

南昌大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital of Nanchang University 

研究实施负责(组长)单位地址:

江西省南昌市东湖区永外正街17号 

Primary sponsor's address:

17 Yongwai Main Street, Donghu District, Nanchang, Jiangxi, 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):

江西省

市(区县):

南昌

Country:

China

Province:

JIangxi

City:

Nanchang

单位(医院):

南昌大学第一附属医院

具体地址:

东湖区永外正街17号

Institution
hospital:

The First Affiliated Hospital of Nanchang University

Address:

17 Yongwai Main Street, Donghu District,

经费或物资来源:

政府 

Source(s) of funding:

Government 

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:

通过使用双氢青蒿素哌喹治疗轻型/普通型新型冠状病毒肺炎(COVID-19)的临床疗效评价,为新型冠状病毒的临床治疗提供新的有效治疗药物,改善该疾病的预后。  

Objectives of Study:

The clinical efficacy of dihydroartemisinin piperaquine in the treatment of mild/common novel coronavirus pneumonia (covid-19) was evaluated to provide new effective drugs for the clinical treatment of novel coronavirus and improve the prognosis of this disease. 

药物成份或治疗方案详述:

对照组:根据新型冠状病毒感染的肺炎诊疗方案(试行第六版),抗病毒治疗选用:α-干拢素(每次500万U 每日2次雾化)+阿比多尔 0.2 每日3次, 7天: 试验组:对照组基础上加用双氢青蒿素哌喹片(每片含双氢青蒿素 40mg, 哌喹 320mg) 每次2片,每日2次,7天。 

Description for medicine or protocol of treatment in detail:

Control group: according to the diagnosis and treatment scheme for novel coronavirus pneumonia infection (trial version 6), antiviral treatment was selected as: α-interferon (5 million U bid atomization ) + Ardibdol 0.2 tid, 7 days. Experimental group: based on control group, dihydroartemisinin piperaquine tablets (each containing 40mg dihydroartemisinin and 320mg piperaquine 2 tablets, bid 7 days.  

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

同意参加本试验并签署知情同意书的轻型/普通型新型冠状病毒肺炎患者。  

Inclusion criteria

Patients with mild/common novel coronavirus pneumonia who agreed to participate in this trial and signed the informed consent form 

排除标准:

研究者认为受试者有其他不适宜参加临床试验的情况或其他特殊情况。  

Exclusion criteria:

The investigator considers that the subject has other conditions that make him/her unsuitable to participate in the clinical trial or other special circumstances. 

研究实施时间:

Study execute time:

From2020-02-23To 2020-04-30 

征募观察对象时间:

Recruiting time:

From2020-02-23To 2020-04-30 

干预措施:

Interventions:

组别:

试验组

样本量:

20

Group:

experimental group

Sample size:

干预措施:

双氢青蒿素哌喹片联合抗病毒治疗

干预措施代码:

Intervention:

dihydroartemisinin piperaquine tablets combined with antiviral treatment.

Intervention code:

组别:

对照组

样本量:

20

Group:

control group

Sample size:

干预措施:

抗病毒治疗:α-干拢素+阿比多尔

干预措施代码:

Intervention:

antiviral treatment was selected as: α-interferon and Ardibdol

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

华中科技大学同济医学院附属协和医院肿瘤中心 

单位级别:

三级甲等 

Institution
hospital:

Cancer Center, Xiehe Hospital,Tongji Medical College, Huazhong University of Science and Technology  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

新型冠状病毒核酸转阴的时间

指标类型:

主要指标 

Outcome:

The time when the nucleic acid of the novel coronavirus turns negative

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、CD8 等 T细胞恢复的时间

指标类型:

次要指标 

Outcome:

T cell recovery 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:

发热的缓解时间

指标类型:

次要指标 

Outcome:

Remission time of fever

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胸部影像学改善情况

指标类型:

次要指标 

Outcome:

Improvement of chest imaging

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞和淋巴细胞恢复时间

指标类型:

次要指标 

Outcome:

eukocyte and lymphocyte recovery 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:

药物严重不良反应频率

指标类型:

次要指标 

Outcome:

Frequency of serious adverse drug reactions

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

向重型/危重型转化率

指标类型:

主要指标 

Outcome:

Conversion to heavy/critical type

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:

痰液、咽拭子

组织:

Sample Name:

Sputum and throat swabs

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:

征募研究对象情况:

Recruiting status:

暂停或中断

Suspending

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

由经过培训的专业人员,采用随机数表法进行编号并分组,以患者就诊顺序进行编号(按照纳入标准和排除标准筛选,剔除不符合要求的病例), 以随机数表法的分组结果将患者安排入组,采用开放性分别以常规治疗,常规治疗+双氢青蒿素哌喹片每天同一时间点给药。

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

By trained professionals, numbered and grouped by random indicator method, in order to the patient number (according to the inclusion criteria and exclusion criteria, screening out do not conform to the requirements of cases), by the method of stochastic indicator of the group will arrange into the group of

盲法:

开放

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):

公开发表学术论文

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

Publish academic papers

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:

用EXCEL收集所有入组患者的全部数据在试验完成后6个月内共享

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

Collect all data of all enrolled patients with Excel and share within 6 months after the completion of the trial

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2020-02-22
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