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Clinical comparative study of PD-1 mAb in the treatment of severe and critical patients with novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030028 

最近更新日期:

Date of Last Refreshed on:

2020-03-24 

注册时间:

Date of Registration:

2020-02-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

PD-1单抗用于治疗新型冠状病毒肺炎(COVID-19)重型或危重型患者的临床对照研究 

Public title:

Clinical comparative study of PD-1 mAb in the treatment of severe and critical 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:

PD-1单抗用于治疗新型冠状病毒肺炎(COVID-19)重型或危重型患者的临床对照研究 

Scientific title:

Clinical comparative study of PD-1 mAb in the treatment of severe and critical patients with novel coronavirus disease (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:

康焰 

研究负责人:

康焰 

Applicant:

Yan Kang 

Study leader:

Yan Kang 

申请注册联系人电话:

Applicant telephone:

+86 18980601556 

研究负责人电话:

Study leader's telephone:

+86 18980601556 

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:

kangyan_hx@163.com 

研究负责人电子邮件:

Study leader's E-mail:

kangyan_hx@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:

成都市武侯区国学巷37号 

研究负责人通讯地址:

成都市武侯区国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan 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:

ChiECRCT20200035 

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:

中国注册临床试验伦理审查委员会 

Name of the ethic committee:

China Ethics Committee of Registering Clinical Trials 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-13 

伦理委员会联系人:

米娜 

Contact Name of the ethic committee:

Mina 

伦理委员会联系地址:

中国香港特别行政区九龙塘浸会大学道中国临床试验注册中心香港中心 

Contact Address of the ethic committee:

Chinese Clinical Trial Registry Hong Kong Center, Hong Kong Baptist University Road, Hong Kong SAR, 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:

四川大学华西医院 

Primary sponsor:

West China Hospital 

研究实施负责(组长)单位地址:

成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川省

市(区县):

成都市

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

成都市武侯区国学巷37号

Institution
hospital:

West China Hospital

Address:

37 Guoxue lane, Wuhou District, Chengdu

经费或物资来源:

自筹经费 

Source(s) of funding:

Self-financing 

研究疾病:

新型冠状病毒肺炎 (COVID-19) 

Target disease:

novel coronavirus 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:

探讨PD-1单抗在新冠状病毒肺炎患者免疫治疗中的价值。 

Objectives of Study:

To explore the value of PD-1 mAb in immunotherapy of patients with novel coronavirus disease (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:

(1) 呼吸道标本或血液标本实时荧光RT-PCR检测新型冠状病毒核酸阳性; (2) 呼吸道标本或血液标本病毒基因测序,与已知的新型冠状病毒高度同源; (3) 胸部CT呈肺炎影像学特征; (4) 重型或危重型患者; (5)年龄≥18 岁,男女均可; (6) 受试者自愿加入本研究,签署知情同意书,依从性好,配合随访。 

Inclusion criteria

(1) RT-PCR detection of the respiratory or blood samples shows positive nucleic acid of the novel coronavirus; (2) Gene sequence of the virus in respiratory or blood samples are highly homologous to the known coronaviruses; (3) The CT images of chest shows radiographic features of pneumonia; (4) Patients with severe or critical conditions; (5) Aged >=18, male or female; (6) The subjects should volunteer to join the study, sign the informed consent, have good compliance and cooperate with the follow-up. 

排除标准:

(1)受试者存在任何活动性自身免疫病或有自身免疫病病史; (2)给予研究药物前14 天内使用免疫抑制剂、或全身、或可吸收的局部激素治疗以达到免疫抑制目的(剂量>10mg/天泼尼松或其他等疗效激素)的患者; (3)对其他单克隆抗体发生过重度过敏反应; (4)处于妊娠或哺乳期女性; (5)人类免疫缺陷病毒(HIV)感染; (6)凝血功能异常,具有出血倾向或正在接受溶栓或抗凝治疗; (7)已知存在的遗传性或获得性出血及血栓倾向(如血友病人,凝血机能障碍,血小板减少); (8)受试者既往曾接受过其他PD-1 抗体治疗或其他针对PD-1/PD-L1 的免疫治疗。 

Exclusion criteria:

(1) Subjects who have any active autoimmune disease or history of autoimmune disease; (2) Subjects who received immunosuppressive therapy by using immunosuppressant, or systemic or absorbable topic hormone therapy (temprednisone or other therapeutic hormones with a dosage >10 mg/day) within 14 days prior to the administration of the studied drug; (3) Severe allergic reaction to other monoclonal antibodies; (4) Women in pregnancy or lactation; (5) Human immunodeficiency virus (HIV) infection; (6) Subjects with abnormal coagulation, bleeding tendency or undergoing thrombolysis or anticoagulation; (7) Subjects with any known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders or thrombocytopenia); (8) Subjects who have previously received other PD-1 antibody therapy or other immunotherapy for PD-1/PD-L. 

研究实施时间:

Study execute time:

From2020-02-24To 2020-08-31 

征募观察对象时间:

Recruiting time:

From2020-02-24To 2020-08-31 

干预措施:

Interventions:

组别:

试验组

样本量:

20

Group:

Experimental group

Sample size:

干预措施:

PD-1单抗+常规治疗

干预措施代码:

Intervention:

PD-1 mAb + Standard treatment

Intervention code:

组别:

对照组

样本量:

20

Group:

Control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Standard treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北省 

市(区县):

武汉市 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉大学人民医院 

单位级别:

三级甲等 

Institution
hospital:

Renmin Hospital of Wuhan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

中性粒细胞计数

指标类型:

主要指标 

Outcome:

Neutrophil count

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

淋巴细胞计数

指标类型:

主要指标 

Outcome:

Lymphocyte count

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

单核/巨噬细胞计数

指标类型:

主要指标 

Outcome:

Monocyte / macrophage count

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

单核/巨噬细胞功能检测

指标类型:

主要指标 

Outcome:

Monocyte / macrophage function test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NK细胞计数

指标类型:

主要指标 

Outcome:

NK cell count

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

DC细胞计数

指标类型:

主要指标 

Outcome:

DC cell count

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

PD-1 (免疫抑制标志物)

指标类型:

主要指标 

Outcome:

PD-1( immunosuppressive biomarker )

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

PD-L1 (免疫抑制标志物)

指标类型:

主要指标 

Outcome:

PD-L1(immunosuppressive biomarker )

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CTLA4 (免疫抑制标志物)

指标类型:

主要指标 

Outcome:

CTLA4 (immunosuppressive biomarker )

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD79

指标类型:

主要指标 

Outcome:

CD79

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Blnk

指标类型:

主要指标 

Outcome:

Blnk

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Il7r

指标类型:

主要指标 

Outcome:

Il7r

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

T细胞数量

指标类型:

主要指标 

Outcome:

T lymphocyte count

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD4+T细胞数量

指标类型:

主要指标 

Outcome:

CD4+ T lymphocyte count

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD8+T细胞数量

指标类型:

主要指标 

Outcome:

CD8+ T lymphocyte count

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

B淋巴细胞数量

指标类型:

主要指标 

Outcome:

B lymphocyte count

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

自然杀伤细胞数量

指标类型:

主要指标 

Outcome:

NK cell count

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

纯真CD4+T细胞占CD4+T细胞比例

指标类型:

主要指标 

Outcome:

Proportion of navie CD4+ T lymphocytes to CD4+ T lymphocytes

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

记忆CD4+T细胞占CD4+T细胞比例

指标类型:

主要指标 

Outcome:

Proportion of memory CD4+ T lymphocyte to CD4+ T lymphocytes

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD4+T细胞功能亚群占CD4+T细胞比例

指标类型:

主要指标 

Outcome:

Proportion of CD4+ T lymphocyte subsets to CD4+ T lymphocytes

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD8+CD28+亚群占CD8+T细胞比例

指标类型:

主要指标 

Outcome:

Proportion of CD8+ CD28+ subsets to CD8 + T lymphocytes

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD8+T细胞活化比例

指标类型:

主要指标 

Outcome:

Activation ratio of CD8+ T lymphocytes

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD4+T细胞与CD8+T细胞比例

指标类型:

主要指标 

Outcome:

Ratio of CD4+ T lymphocytes to CD8+ T lymphocytes

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:

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 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):

对于具备随机化资格的患者,研究中心将严格按照顺序依次分配随机代码。随机代码将以区组的方式由SAS生成,以确保三个治疗组之间接近平衡(1:1)。

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

For patients eligible for randomization, study center will be assigned random codes in strict order. The random code will be generated by SAS in blocks to ensure basic balance between the two treatment groups.

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):

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):

发表论文

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

Publish academic papers

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2020-02-20
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