Today is 2020-10-31

The efficacy and safety of carrimycin treatment in patients with novel coronavirus pneumonia (COVID-19): a multicenter, randomized, open-label, controlled trial
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注册号:

Registration number:

ChiCTR2000029867 

最近更新日期:

Date of Last Refreshed on:

2020-02-16 

注册时间:

Date of Registration:

2020-02-15 

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病毒肺炎(2019-nCoV)患者疗效和安全性的随机、开放、阳性药对照、多中心临床研究 

Public title:

The efficacy and safety of carrimycin treatment in patients with novel coronavirus pneumonia (COVID-19): a multicenter, randomized, open-label, controlled trial 

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病毒(2019-nCoV)肺炎患者疗效和安全性的随机、开放、阳性药对照、多中心临床研究 

Scientific title:

The efficacy and safety of carrimycin treatment in patients with novel coronavirus pneumonia (COVID-19): a multicenter, randomized, open-label, controlled trial 

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:

韩莹 

研究负责人:

金荣华 

Applicant:

Ying Han 

Study leader:

Ronghua Jin 

申请注册联系人电话:

Applicant telephone:

+86 13520809804 

研究负责人电话:

Study leader's telephone:

+86 13811611118 

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:

gladyshanying@163.com 

研究负责人电子邮件:

Study leader's E-mail:

dinghuiguo@medmail.com.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:

北京市丰台区右安门外西头条8号 

研究负责人通讯地址:

北京市丰台区右安门外西头条8号 

Applicant address:

8 Xitoutou, You'anmen, Fengtai District, Beijing 

Study leader's address:

8 Xitoutou, You'anmen, Fengtai District, Beijing 

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:

首都医科大学附属北京佑安医院 

Applicant's institution:

Beijing You'an Hospital, Capital 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:

京佑科伦字[2020]017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:

首都医科大学附属北京佑安医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Beijing Youan Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-15 

伦理委员会联系人:

孟莎 

Contact Name of the ethic committee:

Sha Meng 

伦理委员会联系地址:

北京市丰台区右安门外西头条8号 

Contact Address of the ethic committee:

8 Xitoutou, You'anmen, Fengtai District, Beijing 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010-83997028 

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:

首都医科大学附属北京佑安医院 

Primary sponsor:

Beijing You'an Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市丰台区右安门外西头条8号 

Primary sponsor's address:

8 Xitoutou, You'anmen, Fengtai District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京佑安医院

具体地址:

丰台区右安门外西头条8号

Institution
hospital:

Bejing You'an Hospital, Capital Medical University

Address:

8 Xitoutiao, You'anmen, Fengtai District

国家:

中国

省(直辖市):

湖北

市(区县):

黄石

Country:

China

Province:

Hubei

City:

Huangshi

单位(医院):

湖北黄石市中心医院

具体地址:

天津路141号

Institution
hospital:

Huangshi Central Hospital of Hubei

Address:

141 Tianjin Road

国家:

中国

省(直辖市):

安徽

市(区县):

阜阳市

Country:

China

Province:

Anhui

City:

Fuyang

单位(医院):

安徽阜阳市第二人民医院

具体地址:

颍河西路1088号

Institution
hospital:

Fuyang Second People's Hospital, Anhui

Address:

1088 Yinghe Road West,

国家:

中国

省(直辖市):

黑龙江

市(区县):

哈尔滨

Country:

China

Province:

Heilongjiang

City:

Harbin

单位(医院):

哈尔滨医科大学附属第二医院

具体地址:

南岗区学府路246号

Institution
hospital:

The Second Affiliated Hospital of Harbin Medical University

Address:

246 Xuefu Road, Nangang District

国家:

中国

省(直辖市):

黑龙江

市(区县):

哈尔滨

Country:

China

Province:

Heilongjiang

City:

Harbin

单位(医院):

黑龙江省医院

具体地址:

香坊区中山路82号

Institution
hospital:

Heilongjiang Provincial Hospital

Address:

18 Zhongshan Road, Xiangfang District

国家:

中国

省(直辖市):

安徽

市(区县):

蚌埠

Country:

China

Province:

Anhui

City:

Bengbu

单位(医院):

蚌埠医学院第一附属医院

具体地址:

长淮路287号

Institution
hospital:

The First Affiliated Hospital of Bengbu Medical College

Address:

287 Changhuai Road

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国医学科学院医药生物技术研究所

具体地址:

天坛西里1号

Institution
hospital:

Institute of Medicine and Biotechnology, Chinese Academy of Medical Sciences

Address:

1 Tiantan Lane West

国家:

中国

省(直辖市):

辽宁

市(区县):

沈阳

Country:

China

Province:

Liaoning

City:

Shenyang

单位(医院):

沈阳药科大学

具体地址:

沈河区文化路103号

Institution
hospital:

Shenyang Pharmaceutical University

Address:

103 Wenhua Road, Shenhe District

国家:

中国

省(直辖市):

辽宁

市(区县):

沈阳

Country:

China

Province:

Liaoning

City:

Shenyang

单位(医院):

沈阳同联集团有限公司

具体地址:

大东区东顺城街育才巷18号

Institution
hospital:

Shenyang Tonglian Group Co., Ltd.

Address:

18 Yucai Lane, Shuncheng East Street, Dadong District

经费或物资来源:

中华人民共和国科学技术部 

Source(s) of funding:

Ministry of Science and Technology of the People's Republic of China 

研究疾病:

新型冠状病毒肺炎 

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:

评价可利霉素片对新型冠状病毒(2019-nCoV)感染肺炎患者疗效和安全性,建立新冠肺炎临床治愈标准及疾病进展的早期预警指标或模型,提出新冠肺炎临床有效治疗方案及其科学依据。 

Objectives of Study:

To evaluate the efficacy and safety of carrimycin treatment patients in with novel coronavirus infectious disease (COVID-19), and to explore the clinical cure standards of COVID-19 and early prediction factors of disease progression. 

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; 3. 符合新型冠状病毒(2019-nCoV)感染肺炎诊断标准(第五版); 4. SOFA评分:2分~13分。 病例分层: 1、轻型(n=200):临床症状轻微或无症状,影像学未见肺炎表现,但咽拭纸或漱口液2019-nCOV阳性。 2、普通型(n=160):具有发热、呼吸道等症状,影像学可见肺炎表现。 3、重型(n=80):符合下列任何一条: (1)呼吸窘迫,RR≥30次/分; (2)静息状态下,指氧饱和度≤93%; (3)动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg(1mmHg=0.133kPa)。 4、危重型(n=80):符合以下情况之一者: (1)出现呼吸衰竭,且需要机械通气; (2)出现休克; (3)合并其他器官功能衰竭需ICU监护治疗。 

Inclusion criteria

1. Subjects have signed informed consent; agree not to participate in other clinical studies within 30 days from the first administration of the research drug to the last administration. 2. Aged >= 18 and <= 75 years. 3. Met the diagnostic criteria for COVID-19 (fifth edition, China). 4. SOFA score: 2 to 13 points. COVID-19 clinical stratifications: 1. Mild (n = 200): The clinical symptoms are mild or asymptomatic, and no pneumonia is seen on imaging, but the throat swab or mouthwash 2019-nCOV is positive. 2. General type (n = 160): with fever, respiratory tract symptoms, etc. Imaging shows pneumonia. 3. Severe type (n = 80): Meet any of the following criteria. (1) Respiratory distress, RR >= 30 times / minute. (2) In the resting state, the oxygen saturation is <= 93%. (3) Arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <= 300mmHg (1mmHg = 0.133kPa). 4. Critical type (n = 80): One of the following criteria: (1) Respiratory failure (ARDS) occurs and requires mechanical ventilation. (2) Shock. (3) Combined failure of other organs requires ICU monitoring and treatment. 

排除标准:

1. 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; 2. 近1周内使用过大环内酯类等抗菌药物的患者; 3. 近一周内接受过洛匹那韦/利托那韦治疗等其他抗2019-nCOV潜在有效药物的患者; 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. Patients who have received immunotherapy (such as PD-1 / L1, CTLA4, etc.) and inflammatory factor modulators (such as Ulinastatin) within one month. 2. Patients who have used antibacterial drugs such as macrolides within one week. 3. Patients who have received other anti-2019-nCOV potentially effective drugs such as Lopinavir and Ritonavir within one week. 4. Those who have undergone organ transplantation or surgery planning within 6 months. 5. Patients with coma or intestinal obstruction can not eat or take medicine. 6. With severe illness affected survival, including uncontrolled malignant tumors that have been metastatic and can not be removed, blood diseases, cachexia, active bleeding, severe malnutrition, HIV, etc.. 7. Pregnant and lactating women, subjects (including male subjects) have a pregnancy plan (including sperm donation, egg donation plan) within the next 6 months or are unable to take effective contraceptive measures. 8. Patients with allergies or allergies to macrolide drugs, lopinavir / ritonavir tablets. 9. Patients with contraindications to using lopinavir / ritonavir tablets who plan or are using drugs that interact with the drug (including: highly dependent on CYP3A clearance and increased plasma concentrations can be severe and / or Life-threatening events [narrow therapeutic index] drugs, CYP3A inducers [see the instructions for details]), and can not be stopped or switched to other drugs. 10. Elevated alanine aminotransferase (ALT) / glutaminase (AST) is more than five times the upper limit of normal, total bilirubin is three times the upper limit of normal, or child-Pugh grade C cirrhosis. 11. Extracorporeal life support (ECMO, ECCO2R, RRT). 12. Critical patients with an estimated survival time of < 48 h. 13. Participants in other clinical research in the past month. 14. At the investigator's discretion, patients were deemed unsuitable for inclusion. 

研究实施时间:

Study execute time:

From2020-02-15To 2021-02-28 

征募观察对象时间:

Recruiting time:

From2020-02-15To 2021-02-28 

干预措施:

Interventions:

组别:

试验组

样本量:

260

Group:

Experimental group

Sample size:

干预措施:

可利霉素

干预措施代码:

Intervention:

Carrimycin

Intervention code:

组别:

对照组

样本量:

260

Group:

Control group

Sample size:

干预措施:

洛匹那韦/利托那韦

干预措施代码:

Intervention:

Lopinavir and Ritonavir Tablets

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京佑安医院 

单位级别:

三甲 

Institution
hospital:

Beijing You'an Hospital, Capital Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

湖北黄石市中心医院 

单位级别:

三甲 

Institution
hospital:

Huangshi Central Hospital of Hubei  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

安徽阜阳市第二人民医院 

单位级别:

三甲 

Institution
hospital:

Fuyang Second People's Hospital, Anhui  

Level of the institution:

Tertiary A 

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二医院 

单位级别:

三甲 

Institution
hospital:

The Second Affiliated Hospital of Harbin Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

黑龙江省医院 

单位级别:

三甲 

Institution
hospital:

Heilongjiang Provincial Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

蚌埠医学院第一附属医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Bengbu Medical College  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国医学科学院医药生物技术研究所 

单位级别:

N/A 

Institution
hospital:

Institute of Medicine and Biotechnology, Chinese Academy of Medical Sciences  

Level of the institution:

N/A 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

沈阳药科大学 

单位级别:

高等院校 

Institution
hospital:

Shenyang Pharmaceutical University  

Level of the institution:

University 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

沈阳同联集团有限公司 

单位级别:

N/A 

Institution
hospital:

Shenyang Tonglian Group Co., Ltd.  

Level of the institution:

N/A 

测量指标:

Outcomes:

指标中文名:

体温恢复正常时间

指标类型:

主要指标 

Outcome:

Body temperature returns to normal 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:

肺部炎症消退时间(HRCT)

指标类型:

主要指标 

Outcome:

Pulmonary inflammation resolution time (HRCT)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗结束时漱口液(咽拭纸)COVID-19 RNA转阴率

指标类型:

主要指标 

Outcome:

Mouthwash (pharyngeal swab) at the end of treatment COVID-19 RNA negative rate

Type:

Primary 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:

粪便

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:

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:

正在进行

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):

采用统计软件R语言产生随机数字。

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

using computer statistical software R to generate random numbers.

盲法:

不设盲

Blinding:

open label

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):

与研究者联系

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

Connect with researcher

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:

有/Yes

注册人:

Name of Registration:

 2020-02-15
return list