注册号: Registration number: |
ChiCTR2000029308 |
最近更新日期: Date of Last Refreshed on: |
2020-03-09 |
注册时间: Date of Registration: |
2020-01-23 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
一项评价洛匹那韦/利托那韦治疗2019新型冠状病毒 (COVID-19)感染住院患者的疗效和安全性随机、开放、对照的研究 |
Public title: |
A randomized, controlled open-label trial to evaluate the efficacy and safety of lopinavir-ritonavir in hospitalized patients with 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: |
一项评价洛匹那韦/利托那韦治疗2019新型冠状病毒感染住院患者的疗效和安全性随机、开放、对照的研究 |
Scientific title: |
A randomized, controlled open-label trial to evaluate the efficacy and safety of lopinavir-ritonavir in hospitalized patients with 2019-nCoV infection |
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: |
刘颖 |
研究负责人: |
张定宇 |
Applicant: |
Liu Ying |
Study leader: |
Zhang Dingyu |
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: |
13507117929 |
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: |
+86 027 85509002 |
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: |
1813886398@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: |
430023 |
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-2020-02.01 |
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: |
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: |
2020-01-10 | ||
伦理委员会联系人: |
詹海燕 |
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Contact Name of the ethic committee: |
Zhan Haiyan |
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伦理委员会联系地址: |
湖北省武汉市东西湖区银潭路1号 |
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Contact Address of the ethic committee: |
1 Yintan Road, Dongxihu District, Wuhan, Hubei, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 027 85509839 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
whsjytyy_ec@163.com |
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: |
中华人民共和国科学技术部 |
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Source(s) of funding: |
Min |
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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: |
评价洛匹那韦/利托那韦治疗新型冠状病毒感染的成人住院患者的疗效和安全性。 |
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Objectives of Study: |
Evaluate the efficacy and safety of lopinavir / ritonavir in adult hospitalized patients with new coronavirus infection. |
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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: |
1.成人(定义为≥ 18 岁); 2.经过PCR确证的新型冠状病毒感染患者。; 3.静息未吸氧状态下,患者SPO2≤94%,或氧合指数小于300mmHg。 |
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Inclusion criteria |
1. Adult aged >=18years old; 2. Patients infected with new coronavirus confirmed by PCR 3. In the state of no oxygen at rest, the patient's SPO2<=94% or the oxygenation index is less than 300mmHg. |
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排除标准: |
1.任何不能让方案安全进行的情况; 2.对洛匹那韦/利托那韦的已知过敏或超敏反应; 3.谷丙转氨酶 (ALT)/谷草转氨酶(AST)升高超过正常上限 5 倍; 4.禁用于洛匹那韦/利托那韦治疗且在研究期间不能更换或停用的药物,例如 CYP3A 抑制剂; 5.妊娠:育龄女性妊娠试验阳性; 6.已知 HIV 感染,因为担心如果未与其他抗 HIV 药物联合使用,会对洛匹那韦/利托那韦产生耐药性; 7.患者可能在 72h 内转至非参与医院; 8.研究者认为不适合者。 |
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Exclusion criteria: |
1. Any situation that makes the programme cannot proceed safely; 2. Known allergy or hypersensitivity reaction to lopinavir / ritonavir; 3. Increase in alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is more than 5 times the upper limit of normal; 4. Use of medications that are contraindicated with lopinavir / ritonavir and that cannot be replaced or stopped during the study period, such as CYP3A inhibitors; 5. Pregnancy: positive pregnancy test for women of childbearing age; 6. Known HIV infection, because of concerns about the development of resistance to lopinavir/rionavir if used without combination with other anti-HIV drugs; 7. Patient likely to be transferred to a non-participating hospital within 72 hours; 8. Researchers consider unsuitable. |
研究实施时间: Study execute time: |
从From2020-01-10至To 2021-01-10 |
征募观察对象时间: Recruiting time: |
从From2020-01-10至To 2021-01-10 |
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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