今天是:2020-05-29 星期五

比较ASC09/利托那韦复方片和洛匹那韦/利托那韦(克力芝)对于新型冠状病毒肺炎(COVID-19)确诊病例的疗效及安全性的随机、开放、多中心的临床研究
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注册号:

Registration number:

ChiCTR2000029603 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

比较ASC09/利托那韦复方片和洛匹那韦/利托那韦(克力芝)对于新型冠状病毒肺炎(COVID-19)确诊病例的疗效及安全性的随机、开放、多中心的临床研究 

Public title:

A Randomized, Open-Label, Multi-Centre Clinical Trial Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Confirmed Cases of Novel Coronavirus Pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

比较ASC09/利托那韦复方片和洛匹那韦/利托那韦(克力芝)对于新型冠状病毒肺炎(COVID-19)确诊病例的疗效及安全性的随机、开放、多中心的临床研究 

Scientific title:

A Randomized, Open-Label, Multi-Centre Clinical Trial Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Confirmed Cases of 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:

刘健 

研究负责人:

裘云庆 

Applicant:

Liu Jian 

Study leader:

Qiu Yunqing 

申请注册联系人电话:

Applicant telephone:

+86 13958054006 

研究负责人电话:

Study leader's telephone:

+86 13588189339 

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:

lindaliu87@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

qiuyq@zju.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:

浙江省杭州市庆春路79号 

研究负责人通讯地址:

浙江省杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang, China 

Study leader's address:

79 Qingchun Road, Hangzhou, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

310003 

研究负责人邮政编码:

Study leader's postcode:

310003 

申请人所在单位:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Zhejiang University School of Medicine 

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:

(2020)IIT会审第(8)号,(2020)IIT快审第(6)号 

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:

浙江大学医学院附属第一医院临床研究伦理委员会  

Name of the ethic committee:

The Clinical Research Ethic Committee of the First Affiliated Hospital of Zhejiang University School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-05 

伦理委员会联系人:

蒋怡雅 

Contact Name of the ethic committee:

Jiang Yiya 

伦理委员会联系地址:

浙江省杭州市庆春路79号 

Contact Address of the ethic committee:

79 Qingchun Road, Hangzhou, Zhejiang, China 

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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Zhejiang University School of Medicine 

研究实施负责(组长)单位地址:

浙江省杭州市庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Hangzhou, Zhejiang, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属第一医院

具体地址:

庆春路79号

Institution
hospital:

The First Affiliated Hospital, Zhejiang University School of Medicine

Address:

79 Qingchun Road

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:

比较ASC09/利托那韦复方片(代号ASC09F)和洛匹那韦/利托那韦对新型冠状病毒感染的肺炎确诊病例的疗效及安全性。 

Objectives of Study:

Compare the efficacy and safety of ASC09/Ritonavir (code ASC09F) compound tablets and Lopinavir/Ritonavir(Kelizhi) in patients with 2019-nCoV pneumonia. 

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18-75岁(含界值),性别不限。 (2)新型冠状病毒核酸检查(RT-PCR)检查阳性,并伴有临床表现的确诊新型冠状病毒感染的肺炎患者。诊断标准参考《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》。 (3)已住院的新诊断的呼吸系统不适的患者(呼吸系统不适确诊时间不超过7天)。 (4)女性及伴侣近半年内无计划妊娠者,且愿意从研究药物首次给药起至末次给药后30日内采取有效措施避孕者。 (5)同意从研究药物首次给药起至末次给药后30日内不参加其他临床研究者。 (6)自愿签署知情同意书的患者。 

Inclusion criteria

1. Aged 18-75 years old; 2. Patients with novel coronavirus infection pneumonia were confirmed by RT-PCR and clinical symptoms. The diagnostic criteria refer to "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5)"; 3. Patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 7 days); 4. Women and partners who have no planned pregnancy within the past six months, and are willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration; 5. Agree not to participate in other clinical studies within 30 days from the first administration of the study drug to the last administration; 6. Patients who voluntarily signed informed consent. 

排除标准:

(1) 重型新型冠状病毒感染的肺炎患者,符合以下条件之一:呼吸窘迫,RR≥30 次/分;或者静息状态下,SaO2/SpO2 ≤ 93%;或者动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤ 300mmHg(1mmHg=0.133kPa)。 (2)危重型新型冠状病毒感染的肺炎患者,符合以下条件之一:出现呼吸衰竭且需要机械通气;或者出现休克;或者合并其他器官功能衰竭需ICU 监护治疗。 (3)严重的肝脏疾病(如Child Pugh评分≥C,AST> 5倍上限)。 (4)对ASC09/利托那韦复方片中成分过敏患者。 (5)具有利托那韦片说明书中明确相关禁忌症的患者。 (6)女性受试者在筛选期的妊娠试验为阳性。 (7)正在服用HIV蛋白酶抑制剂药物的患者。 (8)研究者判断不适合参加本次临床试验者(如研究期间可能转院治疗患者;合并多种基础疾病患者等)。 

Exclusion criteria:

1. Patients with severe 2019-nCoV pneumonia met one of the following conditions: respiratory distress, RR >= 30 times / min; or SaO2 / SpO2 <= 93% in resting state; or arterial partial pressure of oxygen (PaO2) / concentration of oxygen (FiO2) <= 300MMHG (1mmhg = 0.133kpa); 2. Patients with critical 2019-nCoV pneumonia met one of the following conditions: respiratory failure and mechanical ventilation required; or shock; or combined with other organ failure required ICU monitoring treatment; 3. Severe liver disease (such as child Pugh score >= C, AST > 5 times upper limit); 4. Patients were allergic to the components of ASC09 / ritonavir compound tablets; 5. Patients with definite contraindications in the label of ritonavir tablets; 6. Female subjects pregnancy test was positive during the screening period; 7. Patients who are taking HIV protease inhibitor drugs; 8. Physician judged the patient was not suitable for this clinical trial (for example, patient may be transferred to another hospital during the study period; patient with multiple basic diseases, etc.). 

研究实施时间:

Study execute time:

From2020-02-06To 2020-05-31 

干预措施:

Interventions:

组别:

试验组

样本量:

80

Group:

Experimental group

Sample size:

干预措施:

标准治疗+ASC09/利托那韦

干预措施代码:

Intervention:

Conventional standardized treatment and ASC09/Ritonavir

Intervention code:

组别:

对照组

样本量:

80

Group:

Control 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:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejaing 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital, Zhejiang University School of Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

浙江 

市(区县):

嘉兴 

Country:

China 

Province:

Zhejiang 

City:

Jiaxing 

单位(医院):

嘉兴市第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Hospital of Jiaxing  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

浙江 

市(区县):

湖州 

Country:

China 

Province:

Zhejiang 

City:

Huzhou 

单位(医院):

湖州市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Huzhou Central Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

杭州市萧山区第一人民医院 

单位级别:

三级乙等 

Institution
hospital:

The First People's Hospital of Xiaoshan District, Hangzhou  

Level of the institution:

Tertiary B 

国家:

中国 

省(直辖市):

浙江 

市(区县):

温州 

Country:

China 

Province:

Zhejiang 

City:

Wenzhou 

单位(医院):

温州市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Wenzhou Central Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

综合不良结果发生率。综合不良结果定义(符合其中之一即可):不吸氧下SpO2≤93%;PaO2/FiO2≤300mmHg;不吸氧下呼吸频率≤30 次/分。(时间框:从服药开始14天内)。

指标类型:

主要指标 

Outcome:

The incidence of composite adverse outcome within 14 days after admission: Defined as (one of them) SPO2<= 93% without oxygen supplementation, PaO2/FiO2 <= 300mmHg or RR <=30 breaths per minute.

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床缓解率和缓解时间。临床缓解的定义(符合其中之一即可):基于疾病症状(发热、咳嗽、腹泻、肌痛、呼吸困难)已持续48小时缓解;再无证据表明疾病进展(新出现的呼吸困难,SpO2下降≥3%,未吸氧下呼吸频率≥30 次/分);新冠病毒病原核酸检测阴性。(时间框:从服药开始14天内)。

指标类型:

次要指标 

Outcome:

Clinical recovery rate and time.

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无发热的比例。(时间框:从服药开始14天内)。

指标类型:

次要指标 

Outcome:

Rate of no fever within 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:

无咳嗽的比例。(时间框:从服药开始14天内)。

指标类型:

次要指标 

Outcome:

Rate of no cough within 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:

无呼吸困难的比例。(时间框:从服药开始14天内)。

指标类型:

次要指标 

Outcome:

Rate of no dyspnea within 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:

无需吸氧的比例。(时间框:从服药开始14天内)。

指标类型:

次要指标 

Outcome:

Rate of no requring supplemental oxygen within 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:

新型冠病毒病原核酸检测阴性的比例。(时间框:从服药开始14天内)。

指标类型:

次要指标 

Outcome:

Rate of undectable viral RNA within 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:

机械通气的比例。(时间框:从服药开始14天内)。

指标类型:

次要指标 

Outcome:

Rate of mechanical ventilation within 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:

ICU入院比例。(时间框:从服药开始14天内)。

指标类型:

次要指标 

Outcome:

Rate of ICU admission within 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:

疾病改善相关的实验室指标恢复正常的时间及比例。(时间框:从服药开始14天内)。

指标类型:

次要指标 

Outcome:

Rate and time of laboratory indicators related to disease improvement to return to normal, within 14 days after admission.

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 75 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):

本次试验采用中央随机方式为受试者分派随机号和配发相应研究药物。

Randomization Procedure (please state who generates the random number sequence and by what method):

In this trial, subjects were assigned a random number and a corresponding study drug using a central random method.

盲法:

开放

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):

待完善

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

To be perfected

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:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-06
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