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研究者撤消 磷酸氯喹片联合标准疗法对比标准疗法治疗重型/危重型 2019 冠状病毒病(COVID-19)的随机、双盲、平行对照研究
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注册号:

Registration number:

ChiCTR2000029826 

最近更新日期:

Date of Last Refreshed on:

2020-03-15 

注册时间:

Date of Registration:

2020-02-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

研究者撤消 磷酸氯喹片联合标准疗法对比标准疗法治疗重型/危重型 2019 冠状病毒病(COVID-19)的随机、双盲、平行对照研究 

Public title:

Cancelled by the investigator A randomized, double-blind, parallel, controlled trial for comparison of phosphoric chloroquine combined with standard therapy and standard therapy in serious/critically ill patients with novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

磷酸氯喹片联合标准疗法对比标准疗法治疗重型/危重型 2019 冠状病毒病(COVID-19)的随机、双盲、平行对照研究 

Scientific title:

A randomized, double-blind, parallel, controlled trial for comparison of phosphoric chloroquine combined with standard therapy and standard therapy in serious/critically ill patients with 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:

徐珍 

研究负责人:

毛精华 

Applicant:

Xu Zhen 

Study leader:

Jinghua Mao 

申请注册联系人电话:

Applicant telephone:

+86 18107167977 

研究负责人电话:

Study leader's telephone:

+86 071 68497225 

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:

hbjzyyywlc@163.com 

研究负责人电子邮件:

Study leader's E-mail:

hbjzyyywlc@163.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:

湖北省荆州市荆州区荆中路60号 

研究负责人通讯地址:

湖北省荆州市荆州区荆中路60号 

Applicant address:

60 Jingjing Road, Jingzhou District, Jingzhou, Hubei, China 

Study leader's address:

60 Jingjing Road, Jingzhou District, Jingzhou, Hubei, 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:

荆州市中心医院 

Applicant's institution:

Jingzhou Central Hospital 

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:

2020-004-01 

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:

荆州市中心医院伦理委员会 

Name of the ethic committee:

Ethic committee of Jingzhou Central Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-13 

伦理委员会联系人:

李华荣 

Contact Name of the ethic committee:

Huarong Li 

伦理委员会联系地址:

湖北省荆州市荆州区荆中路60号 

Contact Address of the ethic committee:

60 Jingjing Road, Jingzhou District, Jingzhou, 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:

荆州市中心医院 

Primary sponsor:

Jingzhou Central Hospital 

研究实施负责(组长)单位地址:

湖北省荆州市荆州区荆中路60号 

Primary sponsor's address:

60 Jingjing Road, Jingzhou District, Jingzhou, 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):

湖北省

市(区县):

荆州

Country:

China

Province:

Hubei

City:

Jingzhou

单位(医院):

荆州市中心医院

具体地址:

湖北省荆州市荆州区荆中路60号

Institution
hospital:

Jingzhou Central Hospital

Address:

60 Jingjing Road, Jingzhou District

经费或物资来源:

广州再生医学与健康广东省实验室 

Source(s) of funding:

Guangzhou Regenerative Medicine and Health Guangdong Laboratory 

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:

IV期临床试验 

Study phase:

研究目的:

评价磷酸氯喹片对比安慰剂治疗重型/危重型 2019 冠状病毒病(COVID-19)患者的疗效和安全性 

Objectives of Study:

To compare the efficay and safety of phosphoric chloroquine and placebo in serious/critically ill patients with novel coronavirus(COVID-19) pneumonia. 

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) 符合《新型冠状病毒感染的肺炎诊疗方案(试行第五版修正版)》确诊的 2019 冠状病毒病(COVID-19)患者或临床诊断患者; 2) 年龄≥18 周且≤75 周岁,男女均可; 3) 重症患者符合以下情况之一: - 呼吸窘迫,呼吸频率≥30 次/分 - 静息状态下,指氧饱和度≤93% - 动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg 4) 危重型患者符合以下情况之一: - 出现呼吸衰竭,且需要机械通气 - 出现休克 - 合并其他器官功能衰竭需 ICU 监护治疗 5) 同意参加本试验并签署知情同意书。 

Inclusion criteria

1. Patients who meet the requirements of the New Coronavirus Infected Pneumonia Diagnosis and Treatment Scheme (revision of Trial Version 5); 2. Aged 18-75 years male or female; 3. Serious patient meet one of the following: (1) respiratory distress wiht respiratory rate >=30 breaths/min; (2) oxygen saturation<=93% on quiet status; (3) Arterial partial pressure of oxygen(PaO2)/oxygen concentration<=300mmHg; 4. critically ill patients meet one of the following: (1) Experience respiratory failure and need to receive mechanical ventilation; (2) Experience shock; (3) Complicated with other organs failure and need intensive care and therapy in ICU; 5. Agree to particapate this study and write the informed consent. 

排除标准:

受试者如果符合以下任何一项排除标准,将不能入选本项研究: 1) 吞咽困难,无法口服药物者; 2) 已知合并其他病毒感染所致肺炎; 3) 已经对研究药物氯喹过敏或不耐受者; 4) 患者肝功能明显异常(根据当地实验室参考范围): - ALT 或 AST 水平> 5 倍正常范围上限(ULN)或 - ALT 或 AST 水平> 3 倍 ULN 且总胆红素水平> 2 倍 ULN 或 -需要进行透析治疗或肾小球滤过率≤30 mL/min/1.73 m2。 5) 有明确心脏病史和心律失常及心电图 QT 间期延长的患者; 6) 因原有基础疾病必须使用洋地黄类药物; 7) 有药物滥用或依赖史; 8) 妊娠或哺乳期妇女; 9) 研究者认为不适合参加研究者。 

Exclusion criteria:

If subject meet one of the following exclusion critera, he/she cannot be enrolled in this study: 1. Be dysphagia and cannot receive drud by oral administration; 2. Complicated with pneumonia infected by other virus; 3. Allergy to or intolerance to study drug phosphoric chloroquine; 4. With significantly abnormal liver function( judged per local Laboratory reference range): -ALT/AST>5 times ULN or; -ALT/AST>3 times ULN, and total bilirubin>2 times ULN or; -need dDialysis treatment, or GFR≤30 mL/min/1.73 m2. 5. With definate history of cadiac diease and arrhythmia and QT prolong; 6. Need to receive digitalis for original diease; 7. With history of grug abuse and drug dependency; 8. Pregant or lactating women; 9. One that the investigator consider not applicable for this study. 

研究实施时间:

Study execute time:

From2020-02-17To 2020-03-17 

征募观察对象时间:

Recruiting time:

From2020-02-17To 2020-03-17 

干预措施:

Interventions:

组别:

磷酸氯喹组

样本量:

30

Group:

Phosphoric chloroquine

Sample size:

干预措施:

每天给药2次,每次给药2片+第五版修正版新型冠状病毒诊疗方案推荐的治疗方案

干预措施代码:

Intervention:

2 tablets phosphoric chloroquine BID, complicated with therapy recommended by "New Coronavirus Infected Pneumonia Diagnosis and Treatment Scheme (revision of Trial Version 5)"

Intervention code:

组别:

安慰剂组

样本量:

15

Group:

Placebo

Sample size:

干预措施:

每天给药2次,每次给药2片+第五版修正版新型冠状病毒诊疗方案推荐的治疗方案

干预措施代码:

Intervention:

2 tablets placebo BID

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):

荆州 

Country:

China 

Province:

Hubei 

City:

Jingzhou 

单位(医院):

荆州市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Jingzhou Centeral Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

病死率

指标类型:

主要指标 

Outcome:

Mortality rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床症状改善时间

指标类型:

次要指标 

Outcome:

Time of improvement of clinical 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:

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:

机械通气时间

指标类型:

次要指标 

Outcome:

Duration 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:

住院时间

指标类型:

次要指标 

Outcome:

Hospitalization 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:

检出病毒阳性的患者比例

指标类型:

次要指标 

Outcome:

Proportion of virus positive patients

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:

相关并发症的发生率

指标类型:

次要指标 

Outcome:

Incidence of related complications

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:

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:

尿液

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:

标本中文名:

咽拭子

组织:

Sample Name:

Throat swab

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

由统计师用SAS软件生成随机分配表,研究者根据受试者筛选成功的先后顺序获取随机号。

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

The statistician uses SAS software to generate the random assignment table, and the investigator obtains the random number according to the sequence of successful screening of the subjects.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

发表文章

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

Published articles

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:

无/No

注册人:

Name of Registration:

 2020-02-14
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