今天是:2020-05-29 星期五

洛匹那韦/利托那韦治疗武汉新型冠状病毒肺炎(COVID-19)轻症患者的疗效和安全性随机、开放、对照的研究
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注册号:

Registration number:

ChiCTR2000029539 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

洛匹那韦/利托那韦治疗武汉新型冠状病毒肺炎(COVID-19)轻症患者的疗效和安全性随机、开放、对照的研究 

Public title:

A randomized, open-label study to evaluate the efficacy and safety of Lopinavir-Ritonavir in patients with mild novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

洛匹那韦/利托那韦治疗武汉新型冠状病毒肺炎(COVID-19)轻症患者的疗效和安全性随机、开放、对照的研究 

Scientific title:

A randomized, open-label study to evaluate the efficacy and safety of Lopinavir-Ritonavir in patients with mild novel coronavirus pneumonia (COVID-19) 

研究课题代号(代码):

Study subject ID:

 

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:

王宜 

研究负责人:

赵建平 

Applicant:

Yi Wag 

Study leader:

Jianping Zhao 

申请注册联系人电话:

Applicant telephone:

+86 13886179974 

研究负责人电话:

Study leader's telephone:

+86 13507138234 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

wangyi@tjh.tjmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

zhaojp@tjh.tjmu.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):

 

申请注册联系人通讯地址:

湖北省武汉市解放大道1095号 

研究负责人通讯地址:

湖北省武汉市解放大道1095号 

Applicant address:

1095 Jiefang Avenue, Wuhan, Hubei 

Study leader's address:

1095 Jiefang Avenue, Wuhan, Hubei 

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:

 

申请人所在单位:

华中科技大学同济医学院附属同济医院 

Applicant's institution:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

TJ-C20200102 

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:

华中科技大学同济医学院附属同济医院伦理委员会 

Name of the ethic committee:

The Ethic Committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-27 

伦理委员会联系人:

杜艾桦 

Contact Name of the ethic committee:

Aihua Du 

伦理委员会联系地址:

武汉市解放大道1095号 

Contact Address of the ethic committee:

1095 Jiefang Avenue, Wuhan, Hubei 

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:

华中科技大学同济医学院附属同济医院 

Primary sponsor:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology 

研究实施负责(组长)单位地址:

武汉市解放大道1095号 

Primary sponsor's address:

1095 Jiefang Avenue, Wuhan, Hubei 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

华中科技大学同济医学院附属同济医院

具体地址:

解放大道1095号

Institution
hospital:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address:

1095 Jiefang Avenue, Wuhan, Hubei

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

novel coronavirus pneumonia (COVID-19) 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

评价使用洛匹那韦/利托那韦治疗新型冠状病毒感染的成人轻症患者的疗效和安全性。 

Objectives of Study:

Evaluate the efficacy and safety of lopinavir / ritonavir in the treatment of adult mild patients with novel coronavirus infection. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.年龄≥ 18 岁; 2.经过临床诊断的新型冠状病毒感染患者;或新型冠状病毒血清抗体(IgM或IgG)阳性患者;或经过PCR确证的新型冠状病毒感染患者; 3.症状发作与随机入组之间的时间间隔在7天以内,症状发作主要以发热作为判定依据,若无发热可使用咳嗽、咽痛、乏力、肌痛、腹泻或其他相关症状。 

Inclusion criteria

1. Adult aged >= 18 years old; 2. Patients with unexplained viral pneumonia that have been clinically diagnosed or patients with novel coronavirus serum antibody (IgM or IgG) positive or patients with novel coronavirus infection confirmed by PCR when no rapid diagnostic kit has been developed; 3. The interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used; 

排除标准:

1.任何不能让本方案安全进行的情况; 2.已使用克力芝或remdesivir的患者; 3.无任何临床表现或胸部影像学表现; 4.患者静息未吸氧状态下SpO2≤94%,或氧合指数小于300mmH,或呼吸频率≥24次/分; 5.临床医生判断需要入住ICU的患者; 6.对洛匹那韦/利托那韦已知过敏或超敏反应; 7.有肝硬化基础疾病或谷丙转氨酶 (ALT)大于3?正常值上限(Upper Limit of Normal, ULN)或谷草转氨酶(AST)大于3?ULN; 8.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,例如阿夫唑嗪、胺碘酮、夫西地酸、阿司咪唑、特非那定、哌咪清、双氢麦角胺、麦角新碱、麦角胺、甲麦角新碱、西沙必利、洛伐他汀、辛伐他汀、西地那非、伐他那非、米达唑仑、三唑仑、圣约翰草(贯叶连翘提取物)等; 9.妊娠:育龄女性妊娠试验阳性; 10.哺乳期妇女未停止哺乳; 11.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; 12.患者可能在72h内转至非参与医院。 

Exclusion criteria:

1) Any situation that makes the programme cannot proceed safely; 2) patients who have used Kaletra or remdesivir; 3) no clinical or chest imaging manifestations; 4) In the state of no oxygen at rest, the patient's SPO2 <= 94% or the oxygenation index is less than 300mmHg respiratory rate >= 24/min; 5) Patients who need to be admitted to ICU judged by clinicians; 6) Known allergy or hypersensitivity reaction to lopinavir / ritonavir; 7) Increase in alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is more than 3 times the upper limit of normal; 8) Drugs that are forbidden to be treated with lopinavir / ritonavir and cannot be replaced or stopped during the study period, such as afzosin, amiodarone, fusidic acid, astemizole, terfenadine, piperazine, dihydroergomethane, ergometrine Alkali, ergotamine, methylergometrine, cisapride, lovastatin, simvastatin, sildenafil, vartanafi, midazolam, triazolam, St. John's wort (Hypericum perforatum extract), etc.; 9) Pregnancy: positive pregnancy test for women of childbearing age; 10) lactating women did not stop lactation; 11) Known HIV infection, because of concerns about the development of resistance to lopinavir/rionavir if used without combination with other anti-HIV drugs; 12) Patient likely to be transferred to a non-participating hospital within 72 hours. 

研究实施时间:

Study execute time:

From2020-02-03To 2021-02-02 

干预措施:

Interventions:

组别:

试验组

样本量:

164

Group:

experimental group

Sample size:

干预措施:

标准治疗+洛匹那韦/利托那韦

干预措施代码:

Intervention:

conventional standardized treatment and Lopinavir-Ritonavir

Intervention code:

组别:

对照组

样本量:

164

Group:

control group

Sample size:

干预措施:

标准治疗

干预措施代码:

Intervention:

Conventional standardized treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学同济医学院附属同济医院 

单位级别:

三级甲等 

Institution
hospital:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

入组后14天内adverse outcome 发生率:患者自觉呼吸困难,同时静息未吸氧状态下SpO2≤94%或呼吸频率≥24次/分

指标类型:

主要指标 

Outcome:

The incidence of adverse outcome within 14 days after admission: Patients with conscious dyspnea, SpO2 ≤ 94% or respiratory frequency ≥ 24 times / min in the state of resting without oxygen inhalation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者入组到临床缓解时间:临床症状缓解定义为:患者体温正常>72小时(未服用退热药物或激素情况下)且无自觉无呼吸困难或呼吸困难减轻;

指标类型:

次要指标 

Outcome:

Time from admission to clinical remission: Improvement of clinical symptom was defined as: Patients with normal body temperature > 72 hours (without taking antipyretic drugs or hormones) and no conscious dyspnea or reduction of dyspnea

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

入组后14天体温正常患者比例

指标类型:

次要指标 

Outcome:

The proportion of patients with normal body temperature 14 days after admission

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

入组后14天无咳嗽患者比例

指标类型:

次要指标 

Outcome:

The proportion of patients without cough 14 days after admission

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

入组后14天无呼吸困难患者比例

指标类型:

次要指标 

Outcome:

The proportion of patients without dyspnea 14 days after admission

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

入组后14天无需氧疗患者比例

指标类型:

次要指标 

Outcome:

The proportion of patients without aerobic therapy 14 days after admission

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

入组后第14天患者上/下呼吸道标本新型冠状病毒核酸转阴率

指标类型:

次要指标 

Outcome:

The negative rate of novel coronavirus RNA in upper and lower respiratory tract samples of patients on the 14th day after admission

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者28天内住院/住ICU比例

指标类型:

次要指标 

Outcome:

The proportion of inpatients / residents in ICU within 28 days

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

严重药物不良事件频率

指标类型:

次要指标 

Outcome:

Frequency of serious adverse drug events

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

咽拭子

组织:

Sample Name:

Throat swab

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

痰液

组织:

Sample Name:

Sputum

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age years

性别:

男女均可

Gender:

Both

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)→提交自动生成随机号及研究组别(干预组及对照组)。

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) → S

盲法:

open label

Blinding:

open label

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

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.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-03
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