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青蒿素哌喹片对经羟氯喹和阿比多尔治疗核酸未转阴的轻型和普通型新型冠状病毒肺炎(COVID-19)人群有效性和安全性的随机对照临床研究
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注册号:

Registration number:

ChiCTR2000032915 

最近更新日期:

Date of Last Refreshed on:

2020-05-15 

注册时间:

Date of Registration:

2020-05-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

青蒿素哌喹片对经羟氯喹和阿比多尔治疗核酸未转阴的轻型和普通型新型冠状病毒肺炎(COVID-19)人群有效性和安全性的随机对照临床研究 

Public title:

A randomized controlled trial for the efficacy and safety of artemisinin-pipequine tablets in the treatment of the mild and common type novel coronavirus pneumonia (COVID-19) patients whose nCoV Nucleic acid did not turn negative after treated by hydroxychloroquine and Abidor 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

青蒿素哌喹片对经羟氯喹和阿比多尔治疗核酸未转阴的轻型和普通型新型冠状病毒肺炎人群有效性和安全性的随机对照临床研究 

Scientific title:

A randomized controlled trial for the efficacy and safety of artemisinin-pipequine tablets in the treatment of the mild and common type novel coronavirus pneumonia (COVID-19) patients whose nCoV Nucleic acid did not turn negative after treated by hydroxychloroquine and Abidor 

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:

张红英 

研究负责人:

谢凤杰 

Applicant:

Hongying Zhang 

Study leader:

Fengjie Xie 

申请注册联系人电话:

Applicant telephone:

+86 18520137685 

研究负责人电话:

Study leader's telephone:

+86 13514563699 

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:

zhhy0919@163.com 

研究负责人电子邮件:

Study leader's E-mail:

mdjxfj1971@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:

广州市白云区太和镇永兴村陈太路436号 

研究负责人通讯地址:

黑龙江省牡丹江市爱民区通乡路5号 

Applicant address:

436 Chentai Road, Yongxing Village, Taihe Town, Baiyun District, Guangzhou, Guangdong, China 

Study leader's address:

5 Tongxiang Road, Aimin District, Mudanjiang, 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:

广州中医药大学 

Applicant's institution:

Guangzhou University of China Medicine 

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:

202014 

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:

牡丹江医学院附属红旗医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Hongqi Hospital Affiliated to Mudangjiang Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-05-07 

伦理委员会联系人:

丛军兹 

Contact Name of the ethic committee:

Junzi Cong 

伦理委员会联系地址:

黑龙江省牡丹江市爱民区通乡路5号 

Contact Address of the ethic committee:

5 Tongxiang Road, Aimin District, Mudanjiang, 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:

牡丹江医学院附属红旗医院 

Primary sponsor:

Hongqi Hospital Affiliated to Mudangjiang Medical University 

研究实施负责(组长)单位地址:

黑龙江省牡丹江市爱民区通乡路5号 

Primary sponsor's address:

5 Tongxiang Road, Aimin District, Mudanjiang, 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):

牡丹江医学院附属红旗医院

具体地址:

黑龙江省牡丹江市爱民区通乡路5号

Institution
hospital:

Hongqi Hospital Affiliated to Mudangjiang Medical University

Address:

5 Tongxiang Road, Aimin District, Mudanjiang

经费或物资来源:

广州中医药大学科技产业园有限公司 

Source(s) of funding:

Institute of Science and Technology, Guangzhou University of Chinese Medicine 

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:

以临床核酸转阴时间和核酸转阴率为主要疗效指标,评价青蒿素哌喹片对经羟氯喹和阿比多尔治疗核酸未转阴的新冠病毒肺炎有效性和安全性。 

Objectives of Study:

Based on the clinical nCoV nucleic acid conversion time and the nucleic acid conversion rate as the main efficacy indicators to evaluate the efficacy and safety of artemisinin-pipequine tablets to treat the COVID-19 that nCoV Nucleic acid did not turn negative after treating with hydroxychloroquine and Abidor  

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2-65岁,并签署知情同意书。 2.按照国家卫生健康委发布的“新型冠状病毒肺炎诊疗方案(试行第七版)”诊断标准,已被诊断为新型冠状病毒感染肺炎且经羟基氯喹和阿比多尔治疗核酸未转阴的轻型和普通型新型冠状病毒肺炎患者。具体诊断标准如下:(1)轻型:临床症状轻微,影像学未见肺炎表现。(2)普通型:具有发热、呼吸道等症状,影像学可见肺炎表现。(3)经羟基氯喹和阿比多尔治疗核酸未转阴的轻型和普通型新型冠状病毒肺炎患者 

Inclusion criteria

1. Aged 2 to 65 years old, and signed informed consent; 2. According to the diagnostic criteria of the "New Coronavirus Pneumonia Diagnosis and Treatment Program (Trial Version 7)" issued by the National Health and Health Commission, those who have been diagnosed with CoVID-19 of light and common type and have been treated with hydroxychloroquine and Abidol but nCoV Nucleic acid did not turn negative. The specific diagnostic criteria are as follows: (1) light type: The clinical symptoms are mild, and there is no pneumonia manifestation in imaging; (2) Common type: It has fever, respiratory tract and other symptoms. Pneumonia can be seen on imaging; (3) The patient who have been diagnosed with CoVID-19 of light and common type and have been treated with hydroxychloroquine and Abidol but nCoV Nucleic acid did not turn negative. 

排除标准:

1.妊娠期3个月内的孕妇; 2.肝肾疾病患者及肝肾损伤者; 3.血液病(如白细胞减少、血小板减少等)患者; 4.心电图提示QT严重延长的患者。 

Exclusion criteria:

1. Pregnant women within 3 months of pregnancy; 2. Patients with liver and kidney disease and those with liver and kidney injury 3. Patients with blood diseases (such as leukopenia, thrombocytopenia, etc.). 4. Electrocardiogram prompting patients with severely extended QT. 

研究实施时间:

Study execute time:

From2020-05-07To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2020-05-07To 2020-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

120

Group:

Experimental group

Sample size:

干预措施:

服用青蒿素哌喹片

干预措施代码:

Intervention:

Taking artemisinin-piperaquine

Intervention code:

组别:

对照组

样本量:

120

Group:

Control group

Sample size:

干预措施:

采用非抗病毒药物对症治疗

干预措施代码:

Intervention:

Symptomatic treatment with non-antiviral drugs

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):

牡丹江医院附属红旗医院 

单位级别:

三甲医院 

Institution
hospital:

Hongqi Hospital Affiliated to Mudangjiang Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

耐受性

指标类型:

主要指标 

Outcome:

Tolerance

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新型冠状病毒载量

指标类型:

主要指标 

Outcome:

Viral load of nCoV

Type:

Primary 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:

主要指标 

Outcome:

Blood routine

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫学检查

指标类型:

主要指标 

Outcome:

Immunological examination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血液肝肾功能检查

指标类型:

主要指标 

Outcome:

Blood liver and kidney function 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:

心肌酶生化检查

指标类型:

主要指标 

Outcome:

Myocardial enzyme biochemical examination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图检查

指标类型:

主要指标 

Outcome:

ECG examination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

主要指标 

Outcome:

Urine routine

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体温

指标类型:

主要指标 

Outcome:

body temperature

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脉搏

指标类型:

主要指标 

Outcome:

pulse

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

指标类型:

主要指标 

Outcome:

Breathe

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压

指标类型:

主要指标 

Outcome:

blood pressure

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CT检查

指标类型:

主要指标 

Outcome:

CT examination of the lungs

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:

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:

标本中文名:

咽拭子

组织:

Sample Name:

Throat swab

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

urine

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 2 years
最大 Max age 65 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):

由系统随机分组

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

Randomly grouped by the system

盲法:

未说明

Blinding:

Not stated

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):

纸质

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

Paper

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

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-15
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