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Efficacy of therapeutic effects of hydroxycholoroquine in novel coronavirus pneumonia (COVID-19) patients(randomized open-label control clinical trial)
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注册号:

Registration number:

ChiCTR2000029740 

最近更新日期:

Date of Last Refreshed on:

2020-02-24 

注册时间:

Date of Registration:

2020-02-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

王昱医师:请上传签字盖章版伦理审批文件。 羟氯喹治疗新型冠状病毒(COVID-19)肺炎的临床有效性研究(随机开放对照临床试验) 

Public title:

Efficacy of therapeutic effects of hydroxycholoroquine in novel coronavirus pneumonia (COVID-19) patients(randomized open-label control clinical trial) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

羟氯喹治疗新型冠状病毒(COVID-19)肺炎的临床有效性研究(随机开放对照临床试验) 

Scientific title:

Efficacy of therapeutic effects of hydroxycholoroquine in novel coronavirus pneumonia (COVID-19) patients(randomized open-label control clinical 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:

王昱 

研究负责人:

张卓莉 

Applicant:

Yu Wang 

Study leader:

Zhuoli Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13693374001 

研究负责人电话:

Study leader's telephone:

+86 13901094780 

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:

for_wangyu@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhuoli.zhang@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:

北京西什库大街8号 

研究负责人通讯地址:

北京西什库大街8号 

Applicant address:

8 Xishiku Street, Beijing, China 

Study leader's address:

8 Xishiku Street, Beijing, 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:

北京大学第一医院 

Applicant's institution:

The First hospital of Peking 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科研031 

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:

北京大学第一生物医学研究伦理委员会 

Name of the ethic committee:

Peking University First hospital Human Research Ethics committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-20 

伦理委员会联系人:

汪科 

Contact Name of the ethic committee:

Ke Wang 

伦理委员会联系地址:

北京市西城区大红罗厂街6号 

Contact Address of the ethic committee:

6 Dahongluochang Street, Xicheng District, Beijing  

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:

北京大学第一医院 

Primary sponsor:

The First Hospital of Peking University 

研究实施负责(组长)单位地址:

北京西什库大街8号 

Primary sponsor's address:

8 Xishiku Street, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学第一医院

具体地址:

西什库大街8号

Institution
hospital:

The First hospital of Peking Universityirst hospital of Peking University

Address:

8 Xishiku Street

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:

通过比较是否使用羟氯喹,治疗新型冠状病毒感染患者的临床疗效,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:

Comparing the clinical efficacy of hydroxycloquine in treatment of novel coronavirus infection, to provide new effective drugs to treat novel coronavirus infection and to improve the prognosis of this 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:

同意参加本试验并签署知情同意书的明确诊断的新型冠状病毒感染患者。以国家卫生健康委员会办公厅2020年2月19日发布的相关诊疗方案或后续最新版为依据。 

Inclusion criteria

Patients with novel coronavirus infection who agreed to participate in this trial and signed the informed consent form. The diagnose criteria was according to Diagnostic and treatment protocol of COVID-19 pneumonia published by Chinese General Office of National Health Committee(6th and further edition). 

排除标准:

正在参加其他临床试验的患者;明确存在眼底视网膜黄斑变性或视野缺损病史的患者;已知对4-氨基喹啉类化合物过敏或者使用与羟氯喹有相互作用的药物;急危重症无法口服药物患者;研究者认为其他原因不适宜参加临床试验的情况;妊娠及哺乳期;既往患有严重心脏病、严重消化、神经、眼科疾病的患者,或者目前患有卟啉病、WBC低于2.0*10^9/L,Hb低于60g/L,严重肝肾功能不全(大于正常上限3倍)、心肌酶升高的患者。 

Exclusion criteria:

Patients who is enrolled in other clinical trial who had diagnosed as macular degeneration of retinawere or defects of visual field; who was allergic to 4-aminoquinoline compounds or is prescribed any drug had interactions with hydrocholoroquine emergency or critically ill patients who can not received oral drugs pregnancy or lactation severe heart disease, digestive disease,neurological or ocular disease,or porphyrin; WBC less than 2.0*10^9/L,hemoglobin 60g/L,liver enzyme or creatine higher than 3 times of ULT,or heart marker elevated, unsuitable to participate this trial by investigator or in other special circumstances.  

研究实施时间:

Study execute time:

From2020-02-11To 2020-02-29 

征募观察对象时间:

Recruiting time:

From2020-02-11To 2020-02-29 

干预措施:

Interventions:

组别:

羟氯喹组

样本量:

54

Group:

hydroxychloroquine group

Sample size:

干预措施:

口服羟氯喹0.2每日2次

干预措施代码:

Intervention:

oral intake hydroxycholoroquine 0.2 twice a day

Intervention code:

组别:

对照组

样本量:

24

Group:

control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

conventional therapy

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):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉同济 

单位级别:

三甲 

Institution
hospital:

TongJi Medical College of HUST  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

氧合指数

指标类型:

主要指标 

Outcome:

oxygen index

Type:

Primary indicator 

测量时间点:

基线,1week,2week,3week,4week

测量方法:

Measure time point of outcome:

baseline, 1-week, 2-week, 3-week, 4-week

Measure method:

指标中文名:

每周最高呼吸频率

指标类型:

主要指标 

Outcome:

max respiratory rate

Type:

Primary indicator 

测量时间点:

基线,1week,2week,3week,4week

测量方法:

Measure time point of outcome:

baseline, 1-week, 2-week, 3-week, 4-week

Measure method:

指标中文名:

肺部影像学改变

指标类型:

主要指标 

Outcome:

lung radiography

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

淋巴细胞计数

指标类型:

主要指标 

Outcome:

count of lymphocyte

Type:

Primary indicator 

测量时间点:

基线,1week,2week,3week,4week

测量方法:

Measure time point of outcome:

baseline, 1-week, 2-week, 3-week, 4-week

Measure method:

指标中文名:

体温

指标类型:

主要指标 

Outcome:

temperature

Type:

Primary indicator 

测量时间点:

基线,1week,2week,3week,4week

测量方法:

Measure time point of outcome:

baseline, 1-week, 2-week, 3-week, 4-week

Measure method:

指标中文名:

血压

指标类型:

次要指标 

Outcome:

blood pressure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心率

指标类型:

次要指标 

Outcome:

heart rate

Type:

Secondary indicator 

测量时间点:

基线,1week,2week,3week,4week

测量方法:

Measure time point of outcome:

baseline, 1-week, 2-week, 3-week, 4-week

Measure method:

指标中文名:

合并其他感染

指标类型:

主要指标 

Outcome:

other infection

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫球蛋白

指标类型:

次要指标 

Outcome:

immunoglobin level

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新型冠状病毒转阴的时间

指标类型:

主要指标 

Outcome:

time when the nuleic 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:

预后

指标类型:

主要指标 

Outcome:

prognosis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

淋巴细胞亚群恢复的时间

指标类型:

附加指标 

Outcome:

recovery time of lymphocyte

Type:

Additional 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:

痰或咽拭子或支气管肺泡灌洗液

组织:

Sample Name:

sputum or throat swabs or BALF

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 16 years
最大 Max age 99 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,根据随机数表法的分组结果入组,分为羟氯喹0.2 每日2次治疗组或无羟氯喹治疗组,每日同一时间点服药。

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

By trained professionals, numbered and grouped by random indicator method, the patient id number was aquired by time who was hospitalized, and the patient who will included in this study should fulfill the inclusion criteria and exclusion criteria. All patients included in this study will be divided into ei

盲法:

Not stated

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

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):

上传到ResMan临床试验公共管理平台 (http://www.medresman.org.cn)。

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

uploaded all data 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:

数据采集包括病例记录表,后期录入电子采集和管理系统

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

clinical data will record on CRF (case record form), and data will input in EDC (Electronic Data Capture) system.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-11
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