注册号: Registration number: |
ChiCTR2000030039 |
最近更新日期: Date of Last Refreshed on: |
2020-02-21 |
注册时间: Date of Registration: |
2020-02-21 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
输注康复者恢复期血浆治疗新型冠状病毒肺炎(COVID-19)患者的临床研究 |
Public title: |
Clinical study for infusing convalescent plasma to treat patients with new 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: |
输注康复者恢复期血浆治疗新型冠状病毒肺炎(COVID-19)患者的临床研究 |
Scientific title: |
Clinical study for infusing convalescent plasma to treat patients with new 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: |
汪莉萍 |
研究负责人: |
颜学兵 |
Applicant: |
Liping Wang |
Study leader: |
Xuebing Yan |
申请注册联系人电话: Applicant telephone: |
+86 18052268126 |
研究负责人电话: Study leader's telephone: |
+86 15205215685 |
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: |
163wangliping@163.com |
研究负责人电子邮件: Study leader's E-mail: |
yxbxuzhou@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): |
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申请注册联系人通讯地址: |
江苏省徐州市鼓楼区鲲鹏路9号 |
研究负责人通讯地址: |
江苏省徐州市鼓楼区鲲鹏路9号 |
Applicant address: |
9 Kunpeng Road, Gulou District, Xuzhou, Jiangsu, China |
Study leader's address: |
9 Kunpeng Road, Gulou District, Xuzhou, Jiangsu, 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: |
徐州医科大学附属医院 |
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Applicant's institution: |
Affiliated Hospital of Xuzhou Medical University |
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: |
XYFY2020-KL002-01 |
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: |
徐州医科大学附属医院医学伦理委员会 |
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Name of the ethic committee: |
Medical ethics committee of the Affiliated Hospital of Xuzhou Medical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-02-13 | ||
伦理委员会联系人: |
翟凤平 |
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Contact Name of the ethic committee: |
Fengping Zhai |
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伦理委员会联系地址: |
江苏省徐州市鼓楼区淮海西路99号 |
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Contact Address of the ethic committee: |
99 Huaihai Road West, Gulou District, Xuzhou, Jiangsu, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 0516 85802291 |
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: |
徐州医科大学附属医院 |
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Primary sponsor: |
Affiliated Hospital of Xuzhou Medical University |
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研究实施负责(组长)单位地址: |
江苏省徐州市鼓楼区鲲鹏路9号 |
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Primary sponsor's address: |
9 Kunpeng Road, Gulou District, Xuzhou, Jiangsu, 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: |
本单位 |
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Source(s) of funding: |
the working unit |
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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: |
评价输注康复者恢复期血浆治疗新型冠状病毒肺炎患者的安全性及有效性 |
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Objectives of Study: |
To evaluate the safety and effectiveness of infusing convalescent plasma for treatment of patients with novel coronavirus pneumonia |
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药物成份或治疗方案详述: |
新型冠状病毒康复者恢复期血浆 |
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Description for medicine or protocol of treatment in detail: |
Plasma in convalescent patients with novel coronavirus |
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研究设计: |
非随机对照试验 |
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Study design: |
Non randomized control |
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纳入标准: |
1.诊断符合《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》诊断标准; 2.临床分型为普通型,重型或危重型; 3.受试者年龄≥18周岁患者; 4.患者或其法定监护人自愿参加并签署知情同意书。 |
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Inclusion criteria |
1. The diagnosis conforms to the diagnostic criteria of "pneumonia diagnosis and treatment program for new coronavirus infection (trial version 5)"; 2. Clinical classification is normal,severe or critical; 3. Subject aged >=18 years old; 4. The patient or his/her legal guardian will participate voluntarily and sign the informed consent. |
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排除标准: |
1.高度过敏体质或有严重过敏史,尤其血浆过敏者; 2.医生认为还存在有其他原因不能纳入治疗者。 |
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Exclusion criteria: |
1. Highly allergic constitution or history of severe allergy, especially plasma allergy; 2. The doctor believes that there are other reasons not to include the healer. |
研究实施时间: Study execute time: |
从From2020-02-01至To 2020-02-01 |
征募观察对象时间: Recruiting time: |
从From2020-05-31至To 2020-05-31 |
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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