ChiCTR2000029806 版本V1.1 版本创建时间2020/2/14 10:41:16 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR2000029806 

最近更新时间:

Date of Last Refreshed on:

2020/2/14 10:35:46 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

2019新型冠状病毒(COVID-19)感染重症肺炎的免疫调节治疗 

Public title:

Immunomodulatory Therapy for Severe Novel Coronavirus Pneumonia (COVID-19) 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

重症病人救治及诊疗方案优化 

Scientific title:

Optimization of treatment and diagnosis plan for critically ill patients 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

刘颖 

研究负责人:

夏家安 

Applicant:

Liu Ying 

Study leader:

Xia Jiaan 

申请注册联系人电话:

Applicant telephone:

+86 027-85509088 

研究负责人电话:

Study leader's telephone:

+86 13871120171 

申请注册联系人传真 :

Applicant Fax:

+86 027-85509002 

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:

whsjytyy_gcp@163.com 

研究负责人电子邮件:

Study leader's E-mail:

3131862959@qq.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:

湖北省武汉市东西湖区银潭路1号 

研究负责人通讯地址:

湖北省武汉市东西湖区银潭路1号 

Applicant address:

1 Yintan Road, Dongxihu District, Wuhan, Hubei, China 

Study leader's address:

1 Yintan Road, Dongxihu District, Wuhan, Hubei, China 

申请注册联系人邮政编码:

Applicant postcode:

430023 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

武汉市金银潭医院(武汉市传染病医院) 

Applicant's institution:

Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital)  

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:

KY-2020-10.02 

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:

武汉市传染病医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Wuhan Infectious Disease Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-11 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

武汉市金银潭医院(武汉市传染病医院) 

Primary sponsor:

Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital) 

研究实施负责(组长)单位地址:

湖北省武汉市东西湖区银潭路1号 

Primary sponsor's address:

1 Yintan Road, Dongxihu District, Wuhan, Hubei, 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):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉市金银潭医院(武汉市传染病医院)

具体地址:

东西湖区银潭路1号

Institution
hospital:

Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital)

Address:

1 Yintan Road, Dongxihu District

国家:

中国

省(直辖市):

江苏

市(区县):

南京

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

东南大学附属中大医院

具体地址:

鼓楼区丁家桥87号

Institution
hospital:

Zhongda Hospital Southeast University

Address:

87 Dingjiaqiao, Gulou District

经费或物资来源:

国家科学技术部 

Source(s) of funding:

Ministry of Science and Technology of China 

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:

其它 

Study phase:

N/A 

研究目的:

探讨PD-1和胸腺肽用于伴随淋巴细胞减少的2019新型冠状病毒感染重症肺炎患者的疗效。 

Objectives of Study:

To explore the efficacy of PD-1 and thymosin in patients with 2019-nCoV severe pneumonia associated with lymphocytopenia. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.依据《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》经PCR确诊2019-nCoV感染的2019新型冠状病毒肺炎成年患者; 2.淋巴细胞绝对值< 0. 6×109/L; 3.严重呼吸功能衰竭不超过48小时且需要收治ICU。其中,严重呼吸功能衰竭定义为PaO2/FiO2 < 200 mmHg且需要正压机械通气(包括无创与有创机械通气,PEEP≥5cmH2O)支持。 4.签署知情同意书。 

Inclusion criteria

1. 2019 adult patients with new-type coronavirus pneumonia diagnosed with 2019-nCoV infection by PCR according to the "Pneumonitis Diagnosis and Treatment Protocol for New-type Coronavirus Infection (Trial Version 5)" 2. The absolute value of lymphocytes <0.6x10^9/L; 3. Severe respiratory failure does not exceed 48 hours and requires ICU treatment. Among them, severe respiratory failure is defined as PaO2 / FiO2 <200 mmHg and requires positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP >=5 cmH2O); 4. Sign the informed consent. 

排除标准:

1.年龄< 18岁 2.妊娠或哺乳期女性 3.对试验药物过敏 4.基础疾病非常严重, 预计存活时间小于6个月(如恶性肿瘤晚期); 5.COPD或终末期肺病需要家庭氧疗 6.预计存活时间不超过48小时 7.近3个月曾参加其他临床干预试验 8.患有自身免疫性疾病 9.有器官、骨髓或造血干细胞移植史 10.6个月内因恶性肿瘤接受过放、化疗 11.HIV感染患者或者过去一年内诊断为获得性免疫缺陷(CD4 T细胞<=200/mm3) 12.正在接受抗丙肝病毒治疗的患者 13.90天存在视网膜脱落或接受眼部手术 14.单眼永久性失明 15.有虹膜炎、眼内炎、巩膜炎或视网膜炎病史 16.主管医生认为不适宜参加本研究 

Exclusion criteria:

1. Age <18 years; 2. Pregnant or lactating women; 3. Allergic to the test drug; 4. The underlying disease is very serious, and the expected survival time is less than 6 months (such as advanced malignant tumors); 5. COPD or end-stage lung disease requires home oxygen therapy 6. Expected survival time does not exceed 48 hours; 7. Participated in other clinical intervention trials in the past 3 months; 8. Suffering from autoimmune diseases; 9. History of organ, bone marrow or hematopoietic stem cell transplant Received radiotherapy and chemotherapy for malignant tumors within 10.6 months; 11. HIV-infected patients or acquired immune deficiency diagnosed within the past year (CD4 T cells <= 200 / mm3); 12. Patients receiving anti-HCV treatment; 13.90 days with retinal detachment or eye surgery; 14. Permanent blindness in one eye; 15. History of iritis, endophthalmitis, scleritis, or retinitis; 16. The doctor in charge considers it inappropriate to participate in this study. 

研究实施时间:

Study execute time:

From2020-01-01To 2021-01-31 

干预措施:

Interventions:

组别:

胸腺肽治疗组

样本量:

40

Group:

Thymosin treatment group

Sample size:

干预措施:

日达仙1.6 mg sc qd,疗程5天。

干预措施代码:

Intervention:

Thymosin for injection 1.6 mg sc qd for 5 days

Intervention code:

组别:

PD-1治疗组

样本量:

40

Group:

PD-1 treatment group

Sample size:

干预措施:

卡瑞利珠单抗200 mg单次用药,稀释至100ml静脉输注

干预措施代码:

Intervention:

Camrelizumab 200 mg single dose, diluted to 100 ml intravenous infusion

Intervention code:

组别:

常规治疗组

样本量:

40

Group:

Conventional treatment group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Conventional 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 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉市金银潭医院(武汉市传染病医院) 

单位级别:

三级医院 

Institution
hospital:

Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital)  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

随机后7天的肺损伤评分下降1分或以上的患者比例

指标类型:

主要指标 

Outcome:

Proportion of patients with a lung injury score reduction of 1-point or more 7 days after randomization

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:

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:

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

Pending

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):

根据不同研究中心以及之前是否使用激素进行分层随机,采用网络随机系统进行随机,将入选患者随机分为胸腺肽治疗组、PD-1治疗组与常规治疗组。

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

According to different research centers and whether to use stratified randomization with hormones and randomized network random system, the selected patients were randomly divided into thymosin treatment group, PD-1 treatment group and conventional treatment group.

UTN(全球唯一识别码):

盲法:

未说明

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

6M

Data collection Institution:

资料管理单位:

试验完成后6个月内共享

Data management Institution:

Sharing within 6 months after trial completion

资料分析单位:

病例记录表

Data analysis Institution:

CRF

注册人:

Name on Registration:

 2020-02-14