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: |
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Public title acronym: |
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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: |
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Scientific title acronym: |
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研究课题代号(代码): Study subject ID: |
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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: |
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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): |
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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: |
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申请人所在单位: |
武汉市金银潭医院(武汉市传染病医院) |
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Applicant's institution: |
Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital) |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
Medical Ethics Committee of Wuhan Infectious Disease Hospital |
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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: |
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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) |
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Primary sponsor: |
Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital) |
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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 |
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Primary sponsor's address: |
1 Yintan Road, Dongxihu District, Wuhan, Hubei, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
国家科学技术部 |
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Source(s) of funding: |
Ministry of Science and Technology of China |
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研究疾病: |
新型冠状病毒肺炎(COVID-19) |
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Target disease: |
Novel Coronavirus Pneumonia (COVID-19) |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||||||||||||||||||||||||
Study phase: |
N/A |
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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。 |
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Objectives of Study: |
To explore the efficacy of PD-1 and thymosin in patients with 2019-nCoV severe pneumonia associated with lymphocytopenia. |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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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。 |
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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. |
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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 |
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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. |
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研究实施时间: Study execute time: |
从From2020-01-01至To 2021-01-31 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Pending |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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。 |
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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. |
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UTN(全球唯一识别码): |
盲法: |
未说明 |
Blinding: |
留 |
试验完成后的统计结果: |
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Calculated Results ater
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研究负责(组长)单位: |
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Organizer institution (leader institution): |
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资料收集汇总单位: |
6M |
Data collection Institution: |
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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 |