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A multicenter, randomized, open, controlled trial for the efficacy and safety of oral kolimycin in the treatment of patients with new coronavirus pneumonia (CoVID-19)
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注册号:

Registration number:

ChiCTR2000032242 

最近更新日期:

Date of Last Refreshed on:

2020-04-24 

注册时间:

Date of Registration:

2020-04-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

评价口服可利霉素对新冠状病毒肺炎(CoVID-19)患者疗效和安全性的随机、开放、对照多中心临床研究 

Public title:

A multicenter, randomized, open, controlled trial for the efficacy and safety of oral kolimycin in the treatment of patients with new coronavirus pneumonia (CoVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价口服可利霉素对新冠状病毒肺炎(CoVID-19)患者疗效和安全性的随机、开放、对照多中心临床研究 

Scientific title:

A multicenter, randomized, open, controlled trial for the efficacy and safety of oral kolimycin in the treatment of patients with new 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:

于凯江 

研究负责人:

于凯江 

Applicant:

Kaijiang Yu 

Study leader:

Kaijiang Yu 

申请注册联系人电话:

Applicant telephone:

+86 13303608899 

研究负责人电话:

Study leader's telephone:

+86 13303608899 

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:

drkaijiang@163.com 

研究负责人电子邮件:

Study leader's E-mail:

drkaijiang@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:

哈尔滨市南岗区邮政街23号 

研究负责人通讯地址:

哈尔滨市南岗区邮政街23号 

Applicant address:

23 Youzheng Street, Nangang District, Harbin, Heilongjiang, China 

Study leader's address:

23 Youzheng Street, Nangang District, 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:

哈尔滨医科大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Harbin Medical 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:

医伦审202004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:

牡丹江市康安医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Mudanjiang Kang'an Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-22 

伦理委员会联系人:

王秋 

Contact Name of the ethic committee:

Wangqiu 

伦理委员会联系地址:

牡丹江市爱民区西地明街358号 

Contact Address of the ethic committee:

358 Xi-Di-Ming Street, Aimin District, Mu-Dan-Jiang, 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:

牡丹江市康安医院 

Primary sponsor:

Mudanjiang Kang'an Hospital 

研究实施负责(组长)单位地址:

牡丹江市爱民区西地明街358号 

Primary sponsor's address:

358 Xi-Di-Ming Street, Aimin District, Mu-Dan-Jiang, 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):

牡丹江

Country:

China

Province:

Heilongjiang

City:

Mudanjiang

单位(医院):

牡丹江市康安医院

具体地址:

牡丹江市爱民区西地明街358号

Institution
hospital:

Mudanjiang Kang'an Hospital

Address:

358 Xi-Di-Ming Street, Aimin District

经费或物资来源:

黑龙江省科学技术厅“重症新型冠状病毒肺炎临床优化治疗研究”应急防治诊疗技术科研攻关项目 

Source(s) of funding:

Novel coronavirus pneumonia clinical optimization treatment study of Heilongjiang provincial science and Technology Department  

研究疾病:

新冠病毒肺炎 

Target disease:

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:

评价可利霉素片对新型冠状病毒感染肺炎(CoVID-19)患者疗效和安全性,提出新冠肺炎临床有效治疗方案。 

Objectives of Study:

To evaluate the efficacy and safety of kolimycin tablets for patients with new coronavirus infection pneumonia (CoVID-19), and to propose a new clinical effective treatment plan for coronary artery 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)受试者或法定代理人已签署知情同意书;同意从研究药物首次给药起至末次给药后30日内不参加其他临床研究者。 2)年龄≥18且≤75周岁;性别不限。 3)符合新型冠状病毒(2019-nCoV)感染肺炎诊断标准(第七版); 4)经治患者或复发患者,符合以下任何一条: ①再次出现发热、或临床症状加重,②咽拭子2019nCOVRNA阴转阳性;③临床症状无改善或2019nCOVRNA持续阳性;④胸部CT显示肺炎症或纤维化进展。 

Inclusion criteria

1. The subject or legal agent has signed the informed consent form; agreed to not participate in other clinical researchers within 30 days from the first administration of the study drug to the last administration. 2. Aged 18 to 75 years old; 3. Meet the diagnostic criteria for pneumonia caused by new coronavirus (2019-nCoV) (seventh edition) 4. Treated patients or relapsed patients meet any of the following: (1) Fever again, or the clinical symptoms worsened; (2) The throat swab 2019nCOVRNA was positive; (3) No clinical symptoms improved or 2019nCOVRNA continued positive; (4) Chest CT showed lung inflammation or fibrosis progress. 

排除标准:

1)其他病毒性肺炎 2)近1个月内接受肿瘤免疫治疗(如PD-1/L1、CTLA4等),及炎症因子调节剂如乌司他丁等患者; 3)近1周内使用过大环内酯类等抗菌药物的患者; 4)近6个月内进行器官移植者或手术计划患者; 5)昏迷、肠梗阻患者无法进食或服药; 6)影响生存的严重基础疾病,包括:未控制已经多处转移不能切除的恶性肿瘤、血液病、恶液质、活动性出血、严重营养不良、HIV等 7)孕妇、哺乳期妇女,受试者(包括男性受试者)在未来6个月内有妊娠计划(包括捐精、捐卵计划)或无法采取有效避孕措施; 8)过敏体质,或对大环内酯内药物、洛匹那韦/利托那韦片过敏的患者; 9)有使用洛匹那韦/利托那韦片禁忌症患者,计划或正在使用与该药物存在相互作用的药物(包括:高度依赖CYP3A清除且血浆浓度升高会伴发严重和/或危及生命的事件[治疗指数较窄]的药物、CYP3A诱导剂[详见说明书]),且不能停用或换用其他药物; 10)谷丙转氨酶(ALT)/谷丙转氨酶(AST)升高超过正常上限5倍,总胆红素超过正常值上限3倍,或child-Pugh C级肝硬化患者。 11)体外生命支持(ECMO、ECCO2R、RRT) 12)预计生存期<48小时危重症患者 13)近1个月内参加其他临床研究者; 14)根据研究者的判断,认为不适合入选的患者。 

Exclusion criteria:

1. Other viral pneumonia; 2. Patients who received tumor immunotherapy (such as PD-1 / L1, CTLA4, etc.) and inflammatory factor regulators such as ulinastatin in the past 1 month; 3. Patients who have used macrolides and other antibacterial drugs in the past week; 4. Patients who have undergone organ transplantation or surgery planning within the past 6 months; 5. Patients with coma and intestinal obstruction cannot eat or take medicine; 6. Serious basic diseases that affect survival, including: uncontrolled malignant tumors that have been metastasized and unresectable, blood diseases, cachexia, active bleeding, severe malnutrition, HIV, etc. 7. Pregnant women and lactating women, subjects (including male subjects) have pregnancy plans (including sperm donation and egg donation plans) or are unable to take effective contraceptive measures within the next 6 months; 8. Patients with allergies or allergies to macrolide drugs and lopinavir / ritonavir tablets; 9. Patients who have contraindications to the use of lopinavir / ritonavir tablets, plan or are using drugs that interact with the drug (including: highly dependent on CYP3A clearance and elevated plasma concentrations will be accompanied by serious and / or endangered Life events [narrow therapeutic index] drugs, CYP3A inducers [see instructions for details], and cannot be stopped or replaced with other drugs; 10. Alanine aminotransferase (ALT) / alanine aminotransferase (AST) rises more than 5 times the upper limit of normal, total bilirubin exceeds 3 times the upper limit of normal, or patients with child-Pugh C liver cirrhosis; 11. In vitro life support (ECMO, ECCO2R, RRT); 12. critically ill patients with an estimated survival time of less than 48 hours; 13. Those who participated in other clinical research within the past month; 14. According to the judgment of the investigator, it is considered unsuitable for the selected patients. 

研究实施时间:

Study execute time:

From2020-04-24To 2021-05-01 

征募观察对象时间:

Recruiting time:

From2020-04-24To 2021-05-01 

干预措施:

Interventions:

组别:

试验组

样本量:

175

Group:

Experimental group

Sample size:

干预措施:

基础治疗+可利霉素

干预措施代码:

Intervention:

Basic treatment + kolimycin

Intervention code:

组别:

对照组

样本量:

175

Group:

Control group

Sample size:

干预措施:

基础治疗

干预措施代码:

Intervention:

Basic treatment

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):

哈尔滨医科大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Harbin Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

牡丹江医学院附属红旗医院 

单位级别:

三甲医院 

Institution
hospital:

Hongqi Hospital Affiliated to Mudanjiang Medical College  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

病毒转阴时间

指标类型:

主要指标 

Outcome:

Virus negative time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

用药治疗3、5、7、9、11、13、15天漱口液(咽拭子)2019-nCOVRNA转阴率(%)

指标类型:

主要指标 

Outcome:

Medication 3, 5, 7, 9, 11, 13, 15 days mouthwash (pharyngeal swab) 2019-nCOVRNA negative 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:

特异性抗体IgM、IgG生成时间

指标类型:

次要指标 

Outcome:

Specific antibody IgM, IgG generation 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:

用药后第1天、5天、10天、15天外周血白细胞计数、生化指标、凝血较基线的变化值

指标类型:

次要指标 

Outcome:

Changes in peripheral blood white blood cell counts, biochemical indicators, and blood coagulation from baseline on day 1, day 5, day 10, and day 15 after medication

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

用药后第1天、第5天、第10天、15天C反应蛋白较基线的变化值

指标类型:

次要指标 

Outcome:

Changes in C-reactive protein from baseline on day 1, day 5, day 10, and day 15 after medication

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间及病死率

指标类型:

次要指标 

Outcome:

Hospitalization time and 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:

出院患者30天复阳率

指标类型:

次要指标 

Outcome:

30-day recovery rate of discharged patients

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:

鼻咽拭子

组织:

Sample Name:

Nasopharyngeal 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):

第三方使用随机数字表进行随机

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

The third party uses a random number table for randomization

盲法:

Open label

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):

是否共享原始数据:

IPD sharing

Yes

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):

https://edc2.jeeyor.net:18080/gooclin4/pages/login/login

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

https://edc2.jeeyor.net:18080/gooclin4/pages/login/login

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, EDC

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-04-24
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