Today is 2020-12-01

Randomized controlled trial for Chloroquine Phosphate in the Treatment of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030718 

最近更新日期:

Date of Last Refreshed on:

2020-03-12 

注册时间:

Date of Registration:

2020-03-11 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

磷酸氯喹用于治疗新型冠状病毒肺炎(COVID-19)的临床研究 

Public title:

Randomized controlled trial for Chloroquine Phosphate 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:

磷酸氯喹用于治疗新型冠状病毒感染的临床研究 

Scientific title:

Clinical Study of Chloroquine Phosphate in the Treatment of 2019-nCoV Infection 

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:

周贤龙 

研究负责人:

赵剡 

Applicant:

Zhou Xianlong 

Study leader:

Zhao Yan 

申请注册联系人电话:

Applicant telephone:

+86 18995549314 

研究负责人电话:

Study leader's telephone:

+86 13995577963 

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:

xianlongzhou@whu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

doctoryanzhao@whu.edu.cn 

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:

武汉市东湖路169号 

研究负责人通讯地址:

武汉市东湖路169号 

Applicant address:

169 Donghu Road, Wuhan, Hubei, China 

Study leader's address:

169 Donghu Road, Wuhan, Hubei, China 

申请注册联系人邮政编码:

Applicant postcode:

430071 

研究负责人邮政编码:

Study leader's postcode:

430071 

申请人所在单位:

武汉大学中南医院 

Applicant's institution:

Zhongnan Hospital of Wuhan 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:

2020019 

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:

武汉大学中南医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee, Zhongnan Hospital of Wuhan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-12 

伦理委员会联系人:

郑磊 

Contact Name of the ethic committee:

Zheng Lei 

伦理委员会联系地址:

武汉市东湖路169号 

Contact Address of the ethic committee:

169 Donghu Road, Wuhan, Hubei, 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:

武汉大学中南医院 

Primary sponsor:

Zhongnan Hospital of Wuhan University 

研究实施负责(组长)单位地址:

武汉市东湖路169号 

Primary sponsor's address:

169 Donghu Road, Wuhan, Hubei, 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):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉大学中南医院

具体地址:

武汉市东湖路169号

Institution
hospital:

Zhongnan Hospital of Wuhan University

Address:

169 Donghu Road

经费或物资来源:

湖北省急救与复苏临床医学研究中心 

Source(s) of funding:

Hubei Clinical Research Center for Emergency and Resuscitation 

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:

评估磷酸氯喹在成人新型冠状病毒感染患者中的疗效及安全性 

Objectives of Study:

Evaluation the efficacy and safety of chloroquine phosphate in the treatment of adult 2019-nCoV infection 

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)男性及女性,≧18岁; 2)确诊病例患者; 3)临床判断仍需要抗病毒治疗; 4)本人或委托代理人签署知情同意书; 5)受试者需能摄取、吸收、耐受口服用药; 6)同意收集临床样本; 7)同意在最后一次口服药物7天内性行为采取避孕措施。 

Inclusion criteria

1. Male and female, older than 18 years; 2. Patients with confirmed COVID19; 3. Need to continue the antivirus therapy; 4. Agree to sign the informed consent; 5. Able to ingest, absorb and tolerate oral medication; 6. Agree to collect clinical samples; 7. Consent to contraceptive measures for sex within 7 days of the last oral medication.  

排除标准:

1)出现严重呕吐且难以口服药物或导致口服后药物难以摄取的病例; 2)孕妇以及哺乳期妇女; 3)受试者在过去30天内参加其他临床试验的; 4)临床预判无生存希望,仅进行临终关怀的病例,或者深度昏迷且在入院三小时内对支持治疗措施无反应的病例; 5)深度休克以及呼吸衰竭的病例; 6)严重的肝脏疾病(如Child Pugh评分≥C级、AST超过正常上限5倍); 7)重度肾功能不全(估计肾小球滤过率≤30mL/min/1.73m2)或正在接受连续性肾脏替代治疗、血液透析、腹膜透析的患者; 8)已知对磷酸氯喹存在过敏反应或禁忌症的患者; 9)医生决策认为参加本项研究不符合受试者最大利益,或存在不能安全遵循协定的任何情况。 

Exclusion criteria:

1. Cases with severe vomiting and difficulty in taking drugs orally or causing difficulty in taking drugs after oral administration; 2. Pregnant and lactating women; 3. The subjects participated other clinical trials within 30 days before admission; 4. Cases with no hope of survival, hospice care only, or deep coma and no response to supportive treatment within three hours after admission; 5. Cases of deep shock and respiratory failure; 6. Severe liver diseases (such as child Pugh score >= C, AST more than 5 times of the upper limit of normal); 7. Patients with severe renal insufficiency (estimated glomerular filtration rate <= 30ml / min / 1.73m2) or undergoing continuous renal replacement therapy, hemodialysis, peritoneal dialysis; 8. Patients with known allergic reactions or contraindications to chloroquine phosphate; 9. The doctor decided that it was not in the best interests of the subjects to participate in the study, or there was any situation in which the agreement could not be followed safely.  

研究实施时间:

Study execute time:

From2020-02-12To 2020-05-30 

征募观察对象时间:

Recruiting time:

From2020-02-12To 2020-05-30 

干预措施:

Interventions:

组别:

试验组

样本量:

40

Group:

Experimental group

Sample size:

干预措施:

磷酸氯喹片

干预措施代码:

Intervention:

chloroquine phosphate

Intervention code:

组别:

对照组

样本量:

40

Group:

Control group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

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):

武汉大学中南医院 

单位级别:

三甲医院 

Institution
hospital:

Zhongnan Hospital of Wuhan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

临床恢复时间

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:

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:

呼吸困难加重的发生频率

指标类型:

次要指标 

Outcome:

Frequency of exacerbation of dyspnea

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

非主要症状缓解时间

指标类型:

次要指标 

Outcome:

Remission time of non-primary symptoms

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咽拭子样本2019-nCoV RT-PCR检测转为阴性的时间

指标类型:

次要指标 

Outcome:

Time for 2019-nCoV nucletic acid turning negtive in throat swabs

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

需要吸氧或无创通气的时间

指标类型:

次要指标 

Outcome:

Duration of oxygen inhalation or noninvasive ventilation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

D1,D7咽拭子中2019-nCoV病毒载量

指标类型:

次要指标 

Outcome:

Viral load in throat swabs in first and seventh day

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出院前或者研究终点检测肛拭子病毒载量

指标类型:

次要指标 

Outcome:

Viral load in anal swabs before discharge or at the end of the study

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

D1,D7,D14及出院前或研究终点时血清中抗2019-nCoV的IgG和IgM值

指标类型:

次要指标 

Outcome:

Anti-2019-nCoV IgG and IgM values in serum in first, seventh, fourteenth day, before discharge and at the end of the study

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

D1,D7改良BAP-65评分和DECAF评分

指标类型:

次要指标 

Outcome:

Improved BAP-65 and DECAF scores in first and seventh day

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

D1,D7血常规、血气分析、肝肾功能与血药浓度

指标类型:

次要指标 

Outcome:

Blood routine, blood gas analysis, liver and kidney function and blood drug concentration of chloroquine phosphate in first and seventh day

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

需要机械通气的时间

指标类型:

次要指标 

Outcome:

Days of mechanical ventilation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

影像学恢复时间

指标类型:

次要指标 

Outcome:

Time for recovery in images

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

进展为危重型或死亡的发生率

指标类型:

次要指标 

Outcome:

The incidence of progression to critical illness or death

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间和/或ICU停留时间

指标类型:

次要指标 

Outcome:

Length-of-stay in hospital and/or ICU

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院费用

指标类型:

次要指标 

Outcome:

Cost of money

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

严重不良事件发生率

指标类型:

次要指标 

Outcome:

Incidence of serious 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:

咽拭子

组织:

Sample Name:

Incidence of serious adverse events

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:

肛拭子

组织:

Sample Name:

Anal 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:

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:

标本中文名:

小便

组织:

Sample Name:

urine

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):

统计学专家使用R软件生成随机结果并按照顺序依次装入编有序号的信封中,患者筛选完成后,统计学专家按照患者序号分发对应序号的信封,根据信封内随机结果确定患者入组。

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

Statistical experts use R software to generate random results and put them into numbered envelopes in sequence. After the screening of patients, statistical experts distribute the envelopes with corresponding serial numbers according to the patients' serial numbers.

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):

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):

研究结束后6个月内公共网络平台公布原始数据

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

original data will be published on web-based public database in 6 months after the research

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:

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)

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

Case Record Form and Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-11
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