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Cancelled by the investigator Efficacy and safety of chloroquine phosphate inhalation combined with standard therapy in the treatment of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030417 

最近更新日期:

Date of Last Refreshed on:

2020-03-13 

注册时间:

Date of Registration:

2020-03-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

研究者撤消 磷酸氯喹雾化吸入溶液联合标准疗法治疗新型冠状病毒肺炎(COVID-19)的探索性临床研究 

Public title:

Cancelled by the investigator Efficacy and safety of chloroquine phosphate inhalation combined with standard therapy 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:

磷酸氯喹雾化吸入溶液联合标准疗法治疗新冠肺炎的探索性临床研究 

Scientific title:

Efficacy and safety of chloroquine phosphate inhalation combined with standard therapy in the treatment of 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:

刘立山 

研究负责人:

徐静 

Applicant:

Lishan Liu 

Study leader:

Jing Xu 

申请注册联系人电话:

Applicant telephone:

+86 18646187140 

研究负责人电话:

Study leader's telephone:

+86 18604501911 

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:

18646187140@163.com 

研究负责人电子邮件:

Study leader's E-mail:

18604501911@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:

哈尔滨市利民开发区沈阳大街东、珠海路南利民生物医药研发中心生命医药创业大厦303室 

研究负责人通讯地址:

哈尔滨市利民开发区沈阳大街东、珠海路南利民生物医药研发中心生命医药创业大厦319室 

Applicant address:

Room 303, life medicine venture building, Limin biomedical R & D center, East Shenyang Street and South Zhuhai Road, Limin Development Zone, Harbin, Heilongjiang, China 

Study leader's address:

Room 319, life medicine venture building, Limin biomedical R & D center, East Shenyang Street and South Zhuhai Road, Harbin, Heilongjiang, 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:

哈尔滨培优健迪生物科技有限公司 

Applicant's institution:

Harbin Peiyou Jiandi Biotechnology Co., Ltd 

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]院伦审临医字第(001)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:

黑龙江省社会康复医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Heilongjiang Social Rehabilitation Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-28 

伦理委员会联系人:

王丹 

Contact Name of the ethic committee:

Dan Wang 

伦理委员会联系地址:

黑龙江省哈尔滨市香坊区南直路75号 

Contact Address of the ethic committee:

75 Nanzhi Road, Xiangfang District, Harbin, Heilongjiang, 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:

哈尔滨市传染病医院 

Primary sponsor:

Harbin infectious diseases hospital 

研究实施负责(组长)单位地址:

哈尔滨市香坊区公滨路309号 

Primary sponsor's address:

309 Gongbin Road, Xiangfang District, Harbin, Heilongjiang, 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):

黑龙江

市(区县):

Country:

China

Province:

Heilongjiang

City:

单位(医院):

哈尔滨培优健迪生物科技有限公司

具体地址:

哈尔滨市利民开发区沈阳大街东、珠海路南利民生物医药研发中心生命医药创业大厦319室

Institution
hospital:

Harbin Peiyou Jiandi Biotechnology Co., Ltd.

Address:

Room 319, Life Medicine Entrepreneurship Building, Nanlimin Biomedical Research and Development Center, Shenyang Street East and Zhuhai Road, Limin Development Zone, Harbin

经费或物资来源:

自筹 

Source(s) of funding:

raise independently 

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:

探索性研究/预试验 

Study phase:

研究目的:

探索磷酸氯喹雾化吸入溶液联合标准疗法治疗新冠肺炎的有效性和安全性 

Objectives of Study:

Efficacy and safety of chloroquine phosphate inhalation combined with standard therapy for treating novel coronavirus 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. 年龄:≥18周岁,且≤65周岁患者;男女均可; 2. 有生育能力的合格受试者(男性和女性)必须同意与其伴侣一起自给药开始至停药后6个月内采取有效的避孕措施; 3. 符合新型冠状病毒感染的肺炎临床诊断标准《新型冠状病毒肺炎诊疗方案(最新版)》确诊的新冠肺炎的患者; 4. 三个月内未用氯喹及其衍生物的药物; 5. 签署知情同意书。 

Inclusion criteria

1. Aged 18 to 65 years old, both male and female; 2. The eligible subjects (male and female) with fertility must agree to take effective contraceptive measures from the beginning of self-sufficiency with their partners to 6 months after drug withdrawal; 3. Novel coronavirus pneumonia diagnosis novel coronavirus pneumonia novel coronavirus pneumonia diagnosis and treatment plan (latest edition) is confirmed; 4. Drugs without chloroquine and its derivatives within three months; 5. Sign the informed consent. 

排除标准:

1. 明确对4-氨基喹啉类(如氯喹、羟氯喹、哌喹,氨酚喹等)及类似药物(如伯氨喹等)过敏史的患者; 2. 患有血液系统疾病的患者; 3. 患有听觉受损的患者; 4. 已知患有严重肝病,有肝硬化基础疾病或丙氨酸氨基转移酶(ALT)/天门冬氨酸氨基转移酶(AST)升高超过正常上限2倍的患者; 5. 酗酒或正在服用具有肝毒性药物的患者; 6. 已知肾功能受损(估计的肾小球滤过率[eGFR] < 30 mL/min/1.73m2,使用MDRD方法估计)的患者; 7. 已知6磷酸脱氢酶缺陷症的患者; 8. 近6个月有急性心肌梗死、或者不稳定性心绞痛、严重心律失常(多源频发室早、室速、室颤)等病史;纽约心功能分级(NYHA)III级-IV级; 9. QTc≥450ms; 10. 未纠正的低血钾症、低血镁症患者; 11. 已知患有视网膜疾病、眼底病变、黄斑病变患者; 12. 已知患有精神类疾病的患者; 13. 胰腺炎患者; 14. 处于妊娠期、育龄女性妊娠试验阳性或哺乳期的女性患者; 15. 服用影响药物吸收、代谢和排泄的药物,可延长QTc间期的药物,可影响药物疗效或增加不良反应的药物等; 16. 最近5年内有恶性肿瘤史的患者; 17. 皮肤疾病(包括皮疹,皮炎,银屑病)患者; 18. 已经采取《新型冠状病毒肺炎诊疗方案(最新版)》标准疗法中正在使用2种及2种以上上抗病毒药物患者。 19. 研究者判断不适合参加本次临床试验者。 

Exclusion criteria:

1. Patients with allergic history to 4-aminoquinoline (such as chloroquine, hydroxychloroquine, piperaquine, aminophenquine, etc.) and similar drugs (such as primaquine, etc.) were identified; 2. Patients with blood system diseases; 3. Patients with hearing impairment; 4. Patients with known severe liver disease, basic disease of liver cirrhosis or ALT / AST increased more than 2 times of the upper limit of normal; 5. Patients who drink alcohol or are taking hepatotoxic drugs; 6. Patients with known impairment of renal function (estimated glomerular filtration rate [EGFR] < 30ml / min / 1.73m2, estimated by MDRD method); 7. Patients with known 6-phosphate dehydrogenase deficiency; 8. In the past 6 months, there were history of acute myocardial infarction, unstable angina, serious arrhythmia (multiple frequent ventricular premature, ventricular tachycardia, ventricular fibrillation), NYHA class III-IV; 9.QTc>=450ms; 10. Patients with uncorrected hypokalemia and hypomagnesemia; 11. Patients with known retinopathy, fundus disease and macular disease; 12. Patients known to have mental illness; 13. Patients with pancreatitis; 14. Female patients in pregnancy, childbearing age with positive pregnancy test or lactation; 15. Taking drugs that affect drug absorption, metabolism and excretion, can prolong QTc interval, can affect drug efficacy or increase adverse reactions; 16. Patients with a history of malignancy in the last 5 years; 17. Patients with skin diseases (including skin rash, dermatitis, psoriasis); 18. The novel coronavirus pneumonia diagnosis and treatment scheme (latest edition) has been adopted in the standard treatment of 2 and 2 or more antiviral drugs; 19. The researchers judged that it was not suitable to participate in this clinical trial. 

研究实施时间:

Study execute time:

From2020-03-01To 2020-06-30 

征募观察对象时间:

Recruiting time:

From2020-03-01To 2020-06-30 

干预措施:

Interventions:

组别:

试验组

样本量:

15

Group:

Experimental group

Sample size:

干预措施:

磷酸氯喹雾化吸入溶液联合标准疗法

干预措施代码:

Intervention:

Combined standard therapy of chloroquine phosphate aerosol inhalation solution

Intervention code:

组别:

对照组

样本量:

15

Group:

control group

Sample size:

干预措施:

注射用水雾化吸入联合标准疗法

干预措施代码:

Intervention:

Water for injection atomization inhalation combined with standard therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

哈尔滨市传染病医院 

单位级别:

三级甲等 

Institution
hospital:

Harbin infectious diseases hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

体温恢复正常 3 天以上

指标类型:

主要指标 

Outcome:

Temperature returns to normal for more than 3 days

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸道症状明显好转

指标类型:

主要指标 

Outcome:

Respiratory symptoms improved significantly

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部影像学显示急性渗出性病变明显改善

指标类型:

主要指标 

Outcome:

Pulmonary imaging showed that acute exudative lesions were significantly improved

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

连续两次呼吸道病原核酸检测阴性(采样时间间隔至少 1 天)

指标类型:

主要指标 

Outcome:

Negative for two consecutive tests of respiratory pathogenic nucleic acid (sampling interval at least 1 day)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

转为重症的比例

指标类型:

次要指标 

Outcome:

Proportion of severe cases

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:

Length of stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指氧饱和度

指标类型:

次要指标 

Outcome:

Oxygen saturation

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:

Mechanical ventilation time

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:

标本中文名:

组织:

Sample Name:

sputum

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):

本试验方案所采用的随机数字表由生物统计学专业人员应用专业统计软件包产生,采用区组随机化的方法。

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

The random number table used in this test plan was generated by biostatistics professionals using professional statistical software package, and the method of block randomization was adopted.

盲法:

未说明

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):

发表文章

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

public article

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:

 2020-03-01
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