Today is 2020-06-06

Cancelled due to lack of patient A study for the efficacy of hydroxychloroquine for mild and moderate COVID-19 infectious diseases
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注册号:

Registration number:

ChiCTR2000029760 

最近更新日期:

Date of Last Refreshed on:

2020-02-28 

注册时间:

Date of Registration:

2020-02-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

撤消,原因:无患者 羟氯喹治疗轻中度新型冠状病毒(COVID-19)感染的疗效研究 

Public title:

Cancelled due to lack of patient A study for the efficacy of hydroxychloroquine for mild and moderate COVID-19 infectious diseases 

注册题目简写:

羟氯喹治疗COVID-19感染 

English Acronym:

HCQ for mild/moderate COVID-19 disease 

研究课题的正式科学名称:

一项随机对照临床研究评估羟氯喹对轻中度新型冠状病毒(COVID-19)感染的疗效与安全性 

Scientific title:

A randomized controlled study to evaluate the efficacy and safety of hydroxychloroquine for mild and moderate COVID-19 Infectious diseases 

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:

杨艳利 

研究负责人:

毛华伟 

Applicant:

Yanli Yang 

Study leader:

Huawei Mao 

申请注册联系人电话:

Applicant telephone:

+86 13657676763 

研究负责人电话:

Study leader's telephone:

+86 13928459556 

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:

502613685@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

maohwei@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:

重庆市渝中区临江路74号 

研究负责人通讯地址:

重庆市渝中区中山二路136号 

Applicant address:

74 Linjiang Road, Yuzhong District, Chongqing, China 

Study leader's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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:

重庆医科大学 

Applicant's institution:

Chongqing 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年伦审(1)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:

重庆医科大学附属第二医院伦理委员会 

Name of the ethic committee:

The Ethic Committee of the Second Affiliated Hospital of Chongqing 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:

江涛 

Contact Name of the ethic committee:

Tao Jiang 

伦理委员会联系地址:

重庆市渝中区临江门76号 

Contact Address of the ethic committee:

76 Linjiangmen Yuzhong District, Chongqing, 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:

重庆医科大学附属第二医院 

Primary sponsor:

The Second Affiliated Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区临江路74号 

Primary sponsor's address:

74 Linjiang Road, Yuzhong District, Chongqing, 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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学附属第二医院

具体地址:

渝中区临江路74号

Institution
hospital:

The Second Affiliated Hospital of Chongqing Medical University

Address:

74 Linjiang Road, Yuzhong District

经费或物资来源:

重庆医科大学 

Source(s) of funding:

Chonqing Medical University 

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:

本研究主要目的是为了评价羟氯喹对轻中度新型冠状病毒2019-nCoV感染的疗效与安全性,希望辅助目前2019-nCoV感染患者的治疗。 

Objectives of Study:

To study the efficacy and safety of hydroxychloroquine for mild and moderate 2019-nCoV disease. 

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、签署知情同意; 2、通过RT-PCR确认感染2019-nCoV; 3、遵守研究干预要求。 

Inclusion criteria

1. Informed consent offered; 2. Confirmed infection with 2019-nCoV by RT-PCR; 3. Compliance with the intervention of study. 

排除标准:

1、已知对羟氯喹或4-氨基喹啉过敏; 2、严重肾功能不全(eGFR <= 30 mL/min/1.73m2)、行RRT患者; 3、严重肝病(Child Pugh评分>= C,AST>上限的5倍); 4、患有眼部视网膜病变; 5、癫痫病史; 6、G6PD缺乏症; 7、怀孕或哺乳; 8、服用他莫昔芬的患者; 9、医师判断本研究不符合患者利益者。 

Exclusion criteria:

1. Known allergic to hydroxychloroquine or 4-aminoquinoline; 2. Severe renal impairment (eGFR <= 30 mL/min/1.73 m2), and those with RRT; 3. Severe liver disease (Child Pugh score >= C, AST>5 times upper limit); 4. Pre-existing retinopathy of the eye; 5. History of epilepsy; 6. G6PD deficiency; 7. Pregnant or breastfeeding; 8. Patients taking tamoxifen; 9. The study not in patients' best interests judged by the physician.  

研究实施时间:

Study execute time:

From2020-02-12To 2020-08-11 

干预措施:

Interventions:

组别:

试验组

样本量:

120

Group:

Experimental group

Sample size:

干预措施:

羟氯喹

干预措施代码:

Intervention:

Hydroxychloroquin

Intervention code:

组别:

对照组

样本量:

120

Group:

Control group

Sample size:

干预措施:

洛匹那韦/利托那韦

干预措施代码:

Intervention:

Lopinavir /Ritonavir

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆市公共卫生中心 

单位级别:

三级 

Institution
hospital:

Chongqing Public Health Medical Center  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

三峡中心医院 

单位级别:

三甲 

Institution
hospital:

Three Gorge Central Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

临床好转时间

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:

Time to defervescence

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病毒转阴时间

指标类型:

次要指标 

Outcome:

Time to absence of 2019-nCoV

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎症指标正常时间

指标类型:

次要指标 

Outcome:

Time to normalization of inflammation markers

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸频率正常时间

指标类型:

次要指标 

Outcome:

Time to normalization of respiratory 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:

咳嗽好转时间

指标类型:

次要指标 

Outcome:

Time to normalization of 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:

住院时间

指标类型:

次要指标 

Outcome:

Duration of hospitalization

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部影像改善频率

指标类型:

次要指标 

Outcome:

Frequency of lung radiologic improvement

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸疾病进展频率

指标类型:

次要指标 

Outcome:

Frequency of respiratory progression

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ICU入住率

指标类型:

次要指标 

Outcome:

Frequency of ICU admission

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全因死亡率

指标类型:

次要指标 

Outcome:

All-cause mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件发生频率

指标类型:

次要指标 

Outcome:

Frequency of adverse events

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:

鼻咽拭子

组织:

Sample Name:

Nasopharyngeal swab

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:

标本中文名:

大便

组织:

Sample Name:

Stool

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 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):

本研究中,按纳入标准和排除标准入组病人后,由中央随机系统按 1:1 的比例随机分配到试验组或对照组中,分别接受羟氯喹和和洛匹那韦/利托那韦治疗。

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

In this study, a central randomization system will be used to allocate the patients to the experimental or control group at a ratio of 1:1 after they are recruited. They will be treated by hydroxychloroquine or Lopinavir/Ritonavir respectively.

盲法:

开放

Blinding:

open label

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:

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):

研究完成后6个月在临床试验公共管理平台共享,网址:http://www.medresman.org.cn.

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

The data will be shared within six months after completion of the study on Clinical Trial Management Public Platform, http://www.medresman.org.cn.

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病例记录表系统进行。

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

Data collection and management will be performed through the electronic case record system.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-12
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