Today is 2020-10-31

A randomized, blinded, controlled, multicenter clinical trial to evaluate the efficacy and safety of Ixekizumab combined with conventional antiviral drugs in patients with novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030703 

最近更新日期:

Date of Last Refreshed on:

2020-03-16 

注册时间:

Date of Registration:

2020-03-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

评价依奇珠单抗联合常规抗病毒药物治疗新型冠状病毒肺炎(COVID-19)患者的有效性和安全性的随机盲法对照多中心临床试验 

Public title:

A randomized, blinded, controlled, multicenter clinical trial to evaluate the efficacy and safety of Ixekizumab combined with conventional antiviral drugs in 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:

评价依奇珠单抗联合常规抗病毒药物治疗新型冠状病毒肺炎(COVID-19)患者的有效性和安全性的随机盲法对照多中心临床试验 

Scientific title:

A randomized, blinded, controlled, multicenter clinical trial to evaluate the efficacy and safety of Ixekizumab combined with conventional antiviral drugs in 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:

匡叶红 

研究负责人:

潘频华,匡叶红 

Applicant:

Yehong Kuang 

Study leader:

Pinhua Pan, Yehong Kuang 

申请注册联系人电话:

Applicant telephone:

+86 13574171102 

研究负责人电话:

Study leader's telephone:

+86 13574171102 

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:

yh_927@126.com 

研究负责人电子邮件:

Study leader's E-mail:

pinhuapan668@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:

湖南省长沙市开福区湘雅路87号湘雅医院 

研究负责人通讯地址:

湖南省长沙市开福区湘雅路87号湘雅医院 

Applicant address:

87 Xiangya Road, Kaifu District, Changsha, Hu'nan, China 

Study leader's address:

87 Xiangya Road, Kaifu District, Changsha, Hu'nan, 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:

中南大学湘雅医院 

Applicant's institution:

Xiangya Hospital of Central South 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:

202003025 

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:

中南大学湘雅医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Xiangya Hospital Central South University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-09 

伦理委员会联系人:

中南大学湘雅医院医学伦理委员会 

Contact Name of the ethic committee:

Medical Ethics Committee of Xiangya Hospital Central South University 

伦理委员会联系地址:

湖南省长沙市湘雅路87号 

Contact Address of the ethic committee:

87 Xiangya Road, Kaifu District, Changsha, Hu'nan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0731-84327919 

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:

中南大学湘雅医院 

Primary sponsor:

Xiangya Hospital of Central South University 

研究实施负责(组长)单位地址:

湖南省长沙市开福区湘雅路87号湘雅医院 

Primary sponsor's address:

87 Xiangya Road, Kaifu District, Changsha, Hu'nan, 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):

湖南省

市(区县):

长沙市

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

中南大学湘雅医院

具体地址:

湖南省长沙市开福区湘雅路87号湘雅医院

Institution
hospital:

Xiangya Hospital

Address:

87 Xiangya Road, Kaifu District

国家:

中国

省(直辖市):

湖南省

市(区县):

长沙市

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

中南大学湘雅三医院

具体地址:

长沙市岳麓区桐梓坡路138号

Institution
hospital:

Third Xiangya Hospital of Central South University

Address:

138 Tongzipo Road, Yuelu District

经费或物资来源:

国家级课题项目 

Source(s) of funding:

National project 

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:

初步评价依奇珠单抗联合临床常规抗病毒药物对新型冠状病毒肺炎(COVID-19)的有效性和安全性。 

Objectives of Study:

Preliminary evaluation of the efficacy and safety of Ixekizumab combined with conventional clinical antiviral drugs against new coronavirus pneumonia (COVID-19). 

药物成份或治疗方案详述:

试验分为二个阶段: 1、第一阶段:开放性试验,入组3例COVID-19患者,使用依奇珠单抗治疗+抗病毒治疗(α-干扰素雾化吸入、洛匹那韦/利托那韦、氯喹、利巴韦林、阿比多尔,但不超过3种),初步观察其安全性和疗效7天。 2、第二阶段:采用前瞻性、随机、评估者盲法、对照设计,拟入组40例COVID-19患者,1:1随机分为2个组进行干预,观察14天: 1)试验组(20例):依奇珠单抗+抗病毒治疗(α-干扰素雾化吸入、洛匹那韦/利托那韦、氯喹、利巴韦林、阿比多尔,但不超过3种); 2)对照组(20例):抗病毒治疗(α-干扰素雾化吸入、洛匹那韦/利托那韦、氯喹、利巴韦林、阿比多尔,但不超过3种)。 3、本研究将进行第一阶段结果报伦理委员会评估批准后开展第二阶段研究,如试验组疗效明显超出对照组,将调整2组样本量或提前中止试验。 

Description for medicine or protocol of treatment in detail:

The trial is divided into two phases: 1. The first stage: an open-label trial involving 3 patients with COVID-19 who were treated with Ixekizumab plus antiviral therapy (α-interferon nebulized inhalation, lopinavir / ritonavir, chloroquine , Ribavirin, Abidol, but no more than 3), the safety and efficacy were initially observed for 7 days. 2. The second stage: Prospective, randomized, evaluator-blind, and control design were used to enroll 40 COVID-19 patients. They were randomly divided into 2 groups for intervention 1: 1, and observed for 14 days: 1) Experimental group (20 cases): Ixekizumab + antiviral therapy (α-interferon nebulization inhalation, lopinavir / ritonavir, chloroquine, ribavirin, abidol, but No more than 3); 2) Control group (20 cases): antiviral therapy (α-interferon nebulized inhalation, lopinavir / ritonavir, chloroquine, ribavirin, abidol, but no more than 3). 3. The second phase of the study will be carried out after the first phase results are reported to the ethics committee for evaluation and approval. If the efficacy of the experimental group significantly exceeds that of the control group, the sample size of the two groups will be adjusted or the trial will be terminated in advance. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1)年龄18-75周岁,性别不限。 2)依据《新型冠状病毒感染的肺炎诊疗方案(试行第六版及更新版)》RT-PCR或基因测序确诊为新型冠状病毒肺炎,临床分型为普通型(含重症高危因素)、重型。 注:普通型新型冠状病毒肺炎(含重症高危因素)患者:普通型合并双肺多发病变、或者肺部影像学显示 24~48 小时内病灶明显进展>50%者。 3)IL-6 升高(建议罗氏化学发光法检测)。 4)患者自愿签署知情同意书。 

Inclusion criteria

1. Aged 18 to 75 years old; 2. The diagnosis of new-type coronavirus pneumonia was confirmed by RT-PCR or gene sequencing according to the "Diagnosis and Treatment Scheme for Pneumonia of New Coronavirus Infection (Trial Version 6 and Updated)", and the clinical type was general (including severe high-risk factors) and severe; Note: Patients with common new type of coronavirus pneumonia (including severe high-risk factors): patients with common type with multiple lung multiple lesions, or pulmonary imaging shows that the lesion progresses significantly within 50% within 24 to 48 hours; 3. IL-6 is elevated (Roche chemiluminescence detection is recommended); 4. The patient voluntarily signed the informed consent. 

排除标准:

1)符合以下情况之一的危重型新型肺炎感染: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; 2)对依奇珠单抗或抗病毒药物已知过敏; 3)ALT/AST>5 倍 ULN,中性粒细胞<0.5×109 /L, 血小板小于 50×109 /L; 4)肾功能损害的患者:血清肌酐≥2 mg/dl(176 μmol/l); 5)合并严重的基础疾病,预期生存周期<3月; 6)活动性肝炎、合并有明确的严重细菌感染和真菌感染患者、结核感染、HIV 感染者; 7)明确诊断有恶性肿瘤病变如淋巴增生性疾病等 8)已知活动性克罗恩病; 9)妊娠期或哺乳期女性; 10)近3个月曾参加其他干预性临床试验; 11)研究者认为不宜入组的其他情况。 

Exclusion criteria:

1. Critical new pneumonia infection that meets one of the following conditions: respiratory failure occurs and requires mechanical ventilation; shock; combined organ failure requires ICU monitoring and treatment 2. Known allergies to Ixekizumab or antiviral drugs; 3. ALT / AST> 5 times ULN, neutrophils <0.5x10^9/L, Platelets less than 50x10^9/L; 4. Patients with impaired renal function: serum creatinine >=2 mg/dl (176 umol/l); 5. Combined with severe underlying diseases, the expected life cycle is less than 3 months; 6. Active hepatitis, patients with definite severe bacterial and fungal infections, tuberculosis infection, and HIV infection; 7. Clear diagnosis of malignant tumors such as lymphoproliferative diseases; 8. Known active Crohn's disease; 9. Pregnant or lactating women; 10. Participated in other interventional clinical trials in the past 3 months; 11. Other conditions that the researcher considers unsuitable. 

研究实施时间:

Study execute time:

From2020-03-10To 2020-05-31 

征募观察对象时间:

Recruiting time:

From2020-03-10To 2020-05-31 

干预措施:

Interventions:

组别:

试验组

样本量:

20

Group:

experimental group

Sample size:

干预措施:

依奇珠单抗+抗病毒治疗

干预措施代码:

Intervention:

Ixekizumab and antiviral therapy

Intervention code:

组别:

对照组

样本量:

20

Group:

control group

Sample size:

干预措施:

抗病毒治疗

干预措施代码:

Intervention:

antiviral therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南省 

市(区县):

长沙市 

Country:

China 

Province:

Hunan 

City:

Changsha 

单位(医院):

湘雅医院(武汉协和医院西院区) 

单位级别:

三甲 

Institution
hospital:

Xiangya Hospital (West District of Wuhan Union Medical College Hospital)  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

湖南省 

市(区县):

长沙市 

Country:

China 

Province:

Hunan 

City:

Chasha 

单位(医院):

湘雅三医院(武汉同济医院中法新院区) 

单位级别:

三甲医院 

Institution
hospital:

Third Xiangya Hospital (Sino-French New Hospital District of Wuhan Tongji Hospital)  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

肺部CT

指标类型:

主要指标 

Outcome:

Lung CT

Type:

Primary indicator 

测量时间点:

第7天和第14天

测量方法:

Measure time point of outcome:

Days 7 and 14

Measure method:

指标中文名:

肺功能

指标类型:

次要指标 

Outcome:

Lung function

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

动脉血气分析

指标类型:

次要指标 

Outcome:

Arterial blood gas analysis

Type:

Secondary indicator 

测量时间点:

第3天,7天和第14天

测量方法:

Measure time point of outcome:

Days 3, 7 and 14

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:

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):

采用中心化随机,采用南京医科大学的eLite 随机系统,1:1随机分配患者至试验组及对照组。

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

Centralized randomization, using the eLite stochastic system of Nanjing Medical University, randomly assigned patients to the experimental group and the control group.

盲法:

主要疗效指标CT结果由研究团队之外的第三方盲法评估

Blinding:

The primary outcome measures CT results were assessed by a third-party blind method outside the research team

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):

原始数据于实验完成内6个月公开,公开方式可能采取论文发表的形式

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

The original data will be published within 6 months of the completion of the experiment. The public method may take the form of a research paper.

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:

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-10
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