注册号: Registration number: |
ChiCTR2000030089 |
最近更新日期: Date of Last Refreshed on: |
2020-02-23 |
注册时间: Date of Registration: |
2020-02-22 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
格乐立(阿达木单抗)治疗新型冠状病毒肺炎(COVID-19)重型和危重型患者的安全性和有效性的临床研究 |
Public title: |
A clinical study for the efficacy and safety of Adalimumab Injection in the treatment of patients with severe novel coronavirus pneumonia (COVID-19) |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
一项评价阿达木单抗治疗新型冠状病毒肺炎(COVID-19)重型和危重型患者的安全性和有效性的临床研究 |
Scientific title: |
A randomized, open-label, controlled trial for the efficacy and safety of Adalimumab Injection in the treatment of patients with severe novel coronavirus pneumonia (COVID-19) |
研究课题代号(代码): Study subject ID: |
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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: |
周凌 |
研究负责人: |
徐沪济 |
Applicant: |
Ling Zhou |
Study leader: |
Huji Xu |
申请注册联系人电话: Applicant telephone: |
+86 13651602804 |
研究负责人电话: Study leader's telephone: |
+86 13671609764 |
申请注册联系人传真 : Applicant Fax: |
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: |
doczhouling@163.com |
研究负责人电子邮件: Study leader's E-mail: |
xuhuji@smmu.edu.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): |
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申请注册联系人通讯地址: |
上海市黄浦区凤阳路415号 |
研究负责人通讯地址: |
上海市黄浦区凤阳路415号 |
Applicant address: |
415 Fengyang Road, Huangpu District, Shanghai, China |
Study leader's address: |
415 Fengyang Road, Huangpu District, Shanghai, 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: |
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申请人所在单位: |
上海长征医院 |
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Applicant's institution: |
Shanghai Changzheng 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: |
2020SL004 |
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: |
上海长征医院生物医学研究伦理委员会 |
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Name of the ethic committee: |
Biomedical research ethics committee of Shanghai Changzheng Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-02-22 | ||
伦理委员会联系人: |
孙吕平 |
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Contact Name of the ethic committee: |
Lvping Sun |
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伦理委员会联系地址: |
上海市黄浦区凤阳路415号 |
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Contact Address of the ethic committee: |
415 Fengyang Road, Huangpu District, Shanghai, China |
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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: |
上海长征医院 |
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Primary sponsor: |
Shanghai Changzheng Hospital |
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研究实施负责(组长)单位地址: |
上海市黄浦区凤阳路415号 |
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Primary sponsor's address: |
415 Fengyang Road, Huangpu District, Shanghai, 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: |
上海长征医院课题和百奥泰生物制药股份有限公司捐赠药物 |
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Source(s) of funding: |
Shanghai Changzheng Hospital Project Fund and Drug donation from Bio-Thera Solutions, Ltd. |
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研究疾病: |
新型冠状病毒肺炎 |
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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: |
上市后药物 | ||||||||||||||||||||||
Study phase: |
4 |
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研究目的: |
比较在标准化治疗基础上,观察加/不加阿达木单抗治疗重型以及危重型2019新型冠状病毒(COVID-19)肺炎的临床疗效和安全性 |
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Objectives of Study: |
The clinical efficacy and safety with and without the addition of Adalimumab Injection to conventional treatment of severe and critical 2019 novel coronavirus (COVID-19) pneumonia will be compared on the basis of conventional treatment. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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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: |
符合下列条件者方可成为本研究的受试者: 1.签署书面知情同意。 2.年龄≥18 岁 3.符合NCP重症和危重症诊断标准,即《新型冠状病毒感染的肺炎诊疗方案(试行第六版)》。结合流行病学史、临床表现和病原学检查综合判断。 4.病程在起病后14天内。 5.愿意进行给药前鼻咽或口咽拭子采集。 |
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Inclusion criteria |
Subjects who meet the following conditions can become subjects of this study: 1. Will sign written informed consent. Adolescents or patients who cannot sign informed consent must obtain informed consent from the guardian; 2. Chinese aged >=18 years; 3. In accordance with NCP criteria for severe and critical illness, namely "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)". Combined with the following epidemiological history, clinical manifestations, and pathogenic examinations to make a comprehensive judgment. 4. The course of disease is within 14 days after the onset of illness; 5. Will take nasopharyngeal or oropharyngeal swabs before administration. |
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排除标准: |
具有以下任何一项的患者不能入组本研究: 1.正在参加其他药物临床试验患者; 2.孕妇或哺乳期的女性; 3.ALT/AST>5倍ULN,或中性粒细胞<0.5??109/L,或血小板小于50??109/L; 4.预期生存期<1周; 5.明确诊断有风湿免疫相关疾病; 6.长期口服抗排斥药物或者免疫调节药物; 7.对阿达木单抗单抗或任何辅料发生超敏反应者; 8.肺结核患者; |
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Exclusion criteria: |
1. Patients who are participating in other drug clinical trials; 2. Pregnant or lactating women; 3. ALT / AST> 5 ULN, neutrophils <0.5, platelets less than 50; 4. Expected survival is less than 1 week; 5. Patients diagnosed with rheumatic immune related diseases; 6. Take orally anti rejection drugs or immunomodulatory drugs for a long time; 7. Hypersensitive to adalimumab or any excipients; 8. Patients with active pulmonary tuberculosis, with definite bacterial and fungal infections |
研究实施时间: Study execute time: |
从From2020-02-28至To 2020-08-31 |
征募观察对象时间: Recruiting time: |
从From2020-02-28至To 2020-08-31 |
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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