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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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
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): |
入组前,研究者再次核对入选及排除标准确认受试者是否入组。 研究者关注微信公众号“指南医学”→我的→随机管理→录入受试者信息(按受试者筛选号顺序依次录入)→选择轻症(仅需要吸氧/不吸氧)或重症(需要高流量/无创通气及以上通气支持)→提交自动生成随机号及研究组别(干预组及对照组)。研究医生按照方案要求开医嘱给药治疗。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Prior to enrollment, the researchers rechecked the selection and exclusion criteria to determine if the subjects were enrolled.Researchers pay attention to the WeChat public account “Guide Medicine” → My → Random Management → Enter subject information (entered in the order of the subject's screening number) → C |
盲法: |
Open label |
Blinding: |
Open label |
试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
否No |
共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
本研究将以CAP-China研究者的名义开展。中心项目协调和数据管理将由北京中日友好医院和北京大学提供。本研究的主要出版物将采用CAP-China研究者的姓名,并向所有协调研究者、研究协调员和机构分配完整的信用凭证。 |
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
This study will be conducted on behalf of CAP-China researchers. The central project coordination and data management will be provided by Beijing China-Japan Friendship Hospital and Peking University. |
数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
将由各研究中心接受过培训的工作人员采集所有数据。然后将数据填写在设计的病例报告表(CRF)中,定期由项目组成员录入电子数据库中,并与经验证数据系统中的其他来源提供的数据合并。研究者负责确保录入采集数据的完整、准确与及时记录。然后由项目组对病历中的数据进行审查。按照适用的标准和数据清理程序进行临床数据管理,以确保数据的完整性。 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
All data will be collected by staff trained in each research centre. The data is then filled in a designed case report form (CRF), which is regularly entered by the project team members into an electronic database and merged with data from other sources in the validated data system. The investigator is responsible for ensuring that the data entered is complete, accurate, and timely. The project team then reviews the data in the medical records. Manage clinical data in accordance with applicable standards and data cleaning procedures to ensure data integrity. |
数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |