Today is 2020-10-31

Cancelled by the investigator A randomized, double-blind, parallel, controlled trial for comparison of phosphoric chloroquine combined with standard therapy and standard therapy in mild/common patients with novel coronavirus pneumonia (COV
download

注册号:

Registration number:

ChiCTR2000030031 

最近更新日期:

Date of Last Refreshed on:

2020-03-16 

注册时间:

Date of Registration:

2020-02-21 

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轻型/普通型2019冠状病毒肺炎(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 mild/common patients with novel coronavirus pneumonia (COV 

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轻型/普通型2019冠状病毒肺炎(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 mild/common 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:

缪经纬 

研究负责人:

邓英 

Applicant:

Jingwei Miao 

Study leader:

Ying Deng 

申请注册联系人电话:

Applicant telephone:

+86 18998986610 

研究负责人电话:

Study leader's telephone:

+86 13500296796 

申请注册联系人传真 :

Applicant Fax:

+86 0763-3113605 

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:

qyrygcp@163.com 

研究负责人电子邮件:

Study leader's E-mail:

surewin001@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:

广东省清远市清城区新城B24号区 

研究负责人通讯地址:

广东省清远市清城区曙光二路22号 

Applicant address:

B24 Area, Qingcheng District, Qingyuan, Guangdong, China 

Study leader's address:

22 Second Shuguang Road, Qingcheng District, Qingyuan, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

511518 

研究负责人邮政编码:

Study leader's postcode:

511518 

申请人所在单位:

广州医科大学附属第六医院(清远市人民医院) 

Applicant's institution:

The Sixth Affiliated Hospital of Guangzhou Medical University (Qingyuan People's 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:

IRB-2020-002 

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:

清远市人民医院医学伦理委员会 

Name of the ethic committee:

Institutional Review Board of Qingyuan People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-19 

伦理委员会联系人:

邓源武 

Contact Name of the ethic committee:

Yuanwu Deng 

伦理委员会联系地址:

广东省清远市清城区新城B24号区 

Contact Address of the ethic committee:

B24 Area, Qingcheng District, Qingyuan, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0763-3113629 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

qyryllwyh@163.com 

研究实施负责(组长)单位:

广州医科大学附属第六医院(清远市人民医院) 

Primary sponsor:

The Sixth Affiliated Hospital of Guangzhou Medical University (Qingyuan People's Hospital) 

研究实施负责(组长)单位地址:

广东省清远市清城区新城B24号区、曙光二路22号 

Primary sponsor's address:

B24 Area, Qingcheng District, Qingyuan, Guangdong, 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):

广东

市(区县):

清远

Country:

China

Province:

Guangdong

City:

Qingyuan

单位(医院):

广州医科大学附属第六医院(清远市人民医院)

具体地址:

广东省清远市清城区新城B24号区、曙光二路22号

Institution
hospital:

The Sixth Affiliated Hospital of Guangzhou Medical University (Qingyuan People's Hospital)

Address:

B24 Area, Qingcheng 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:

上市后药物 

Study phase:

研究目的:

主要目的: 通过分析新型冠状病毒核酸转阴时间,评价磷酸氯喹片的抗新型冠状病毒作用。 次要目的: 1.通过其他次要终点指标评估磷酸氯喹片治疗轻型/普通型 2019 冠状病毒病 (COVID-19)患者的有效性; 2.评估磷酸氯喹片治疗 2019 冠状病毒病(COVID-19)患者的安全性。 

Objectives of Study:

Main purpose: To evaluate the efficacy of phosphoric chloroquine for novel coronavirus through clearance time of novel coronavirus. Secondary purpose: 1. To evaluate the efficacy of phosphoric chloroquine for mild/common patients with novel coronavirus(COVID-19) pneumonia through other secondary outcomes; 2. To evaluate the safety of phosphoric chloroquine for patients with novel coronavirus(COVID-19) .  

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:

受试者符合以下所有入选标准才能入选本项研究: 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)》确诊的轻型/普通型 2019 冠状病毒病(COVID-19)患者或临床诊断患者; 2) 年龄≥18 周岁且≤65 周岁,男女均可; 3) 症状发作与随机入组的时间间隔在 7 天以内:症状发作定义为患者出现至少一种全身 性症状(如发热(体温≥37.3℃)或寒战、头痛、乏力、肌肉或关节疼痛等)或呼吸 症状(如咳嗽、咽痛、鼻塞、流涕)。 4) 同意参加本试验并签署知情同意书。 

Inclusion criteria

1. Meet the requirements of the "New Coronavirus Infected Pneumonia Diagnosis and Treatment Scheme (revision of Trial Version 5)"; 2. Aged 18 to 65 years male or female; 3. The interval from the onset of symptoms to enrollment is within 7days: onset of symptoms is defined as onset of at least one systematic symtom(such as fever(temperature>=37.3 degree C) or shivering,headache,hypodynamia,muscle pain or joint pain) or respiratory symptom(such as cough,pharyngodynia,nasal obstruction,rhinorrhea); 4. Agree to participate in this study and write informed content.  

排除标准:

1) 重型、危重型 2019 冠状病毒病(COVID-19)患者或临床医生判断认为需要住进 ICU 患者; 2) 其他病毒感染所致肺炎; 3) 在筛选期间或筛选前 24 小时内检出患者出现以下任何实验室参数异常(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。 4) 经研究者判断,既往或现在患有的疾病,可能影响患者参加试验或影响研究的转归, 包括但不仅限于:恶性肿瘤、自身免疫性疾病、肝肾疾患、心血管系统疾病(包括但 不限于有明确心脏病史和心律失常及心电图 QT 间期延长的患者)、神经系统疾病、 精神系统疾病、活动性出血、严重营养不良和内分泌疾病;现患有严重的呼吸系统基 础疾病或严重影响免疫系统的疾病,如:人类免疫缺陷病毒(HIV)感染,或血液系 统,或脾切除、器官移植术等; 5) 因原有基础疾病必须使用洋地黄类药物; 6) 患者可能在 72h 内转至非参与医院; 7)参加研究前1周内已经服用过磷酸氯喹或羟氯喹者; 8) 已知对研究用药磷酸氯喹过敏者; 9) 有药物滥用或依赖史; 10) 处于妊娠或哺乳期,或计划在研究治疗后 3 个月内怀孕; 11) 研究者认为不适合参加研究者。 

Exclusion criteria:

1. Serious/critically ill patients with novel coronavirus(COVID-19) pneumonia or patients that clinician consider that he/she shall be treated in ICU; 2. With pneumonia infected by other virus; 3. With one of following abnormal laboratory parameters( judged per local Laboratory reference range): -ALT or AST>5 ULN or; -ALT or AST >3 ULN, and total bilirubin>2 ULN; 4. Previous or current disease, judged by investigator, may affect his/her participation in this study or outcome of the study, including but not limited to malignant tumor, autoimmune disease, liver and kidney disease, cardiovascular disease (including but not limited to definate history of cadiac diease and arrhythmia and QT prolongation), neurological disease psychiatric disease, active bleeding,serious malnutrition and endocrine disease; currently complicated with serious respiratory disease or that seriously affect immune system, such as HIV, blood system disease, or splenectomy, organ transplantion etc.; 5. Need to receive digitalis for original disease; 6. May be transfered to non-study hospital; 7.Those who had taken phosphoric chloroquine or hydroxychloroquine within one week before participating in the study 8. Allergy to study drug phosphoric chloroquine or hydroxychloroquine; 9. With history of grug abuse and drug dependency; 10. Pregant or lactating women;or planing to be pregnant within 3 months after study; 11. One that the investigator consider not applicable for this study.  

研究实施时间:

Study execute time:

From2020-02-20To 2021-03-20 

征募观察对象时间:

Recruiting time:

From2020-02-20To 2021-02-20 

干预措施:

Interventions:

组别:

磷酸氯喹组

样本量:

80

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:

40

Group:

Placebo

Sample size:

干预措施:

磷酸氯喹片模拟剂每次 2 片,每日 2 次 +第五版修正案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, complicated with therapy recommended by New Coronavirus Infected Pneumonia Diagnosis and Treatment Scheme (revision of Trial Version 5)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

清远 

Country:

China 

Province:

Guangdong 

City:

Qingyuan 

单位(医院):

广州医科大学附属第六医院(清远市人民医院) 

单位级别:

三级甲等 

Institution
hospital:

The Sixth Affiliated Hospital of Guangzhou Medical University(Qingyuan People's Hospital)  

Level of the institution:

Tertiary A 

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):

武汉东西湖方舱医院 

单位级别:

 

Institution
hospital:

Wuhan Dongxihu Fangcang Hosptial  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

新型冠状病毒核酸转阴时间

指标类型:

主要指标 

Outcome:

Time of conversion to be negative of novel coronavirus nucleic acid

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发热缓解时间

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:

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:

暂停或中断

Suspending

年龄范围:

Participant age:

最小 Min age 18 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:

双盲

Blinding:

Double blind

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):

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:

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:

Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-02-21
return list