今天是:2020-04-08 星期三

巴洛沙韦酯、法匹拉韦对比洛匹那韦/利托那韦(克力芝)在新型冠状病毒肺炎(COVID-19)患者中的疗效和安全性的随机、对照临床研究
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注册号:

Registration number:

ChiCTR2000029548 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

巴洛沙韦酯、法匹拉韦对比洛匹那韦/利托那韦(克力芝)在新型冠状病毒肺炎(COVID-19)患者中的疗效和安全性的随机、对照临床研究 

Public title:

Randomized, open-label, controlled trial for evaluating of the efficacy and safety of Baloxavir Marboxil, Favipiravir, and Lopinavir-Ritonavir in the treatment of novel coronavirus pneumonia (COVID-19) patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

巴洛沙韦酯、法匹拉韦对比洛匹那韦/利托那韦(克力芝)在新型冠状病毒肺炎(COVID-19)患者中的疗效和安全性的随机、对照临床研究 

Scientific title:

Randomized, open-label, controlled trial for evaluating of the efficacy and safety of Baloxavir Marboxil, Favipiravir, and Lopinavir-Ritonavir in the treatment of novel coronavirus pneumonia (COVID-19) patients 

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:

申屠建中 

研究负责人:

裘云庆 

Applicant:

Shentu Jianzhong 

Study leader:

Yunqing Qiu 

申请注册联系人电话:

Applicant telephone:

+86 13957111817 

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:

stjz@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:

 

研究负责人邮政编码:

Study leader's postcode:

 

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, 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(6)号 

伦理委员会批件附件:

Approved file of Ethical Committee:

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:

Clinical Research Ethics Committee of the First Affiliated Hospital,College of Medicine,Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-03 

伦理委员会联系人:

蒋怡雅 

Contact Name of the ethic committee:

Yiya Jiang 

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 

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, 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  

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:

浙江省杭州市庆春路79号

Institution
hospital:

The First Affiliated Hospital, Zhejiang University School of Medicine

Address:

79 Qingchun Road, Hangzhou, Zhejiang

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:

评价巴洛沙韦酯片、法匹拉韦片治疗新型冠状病毒感染的疗效和安全性。 

Objectives of Study:

To evaluate the efficacyand safety of Baloxavir Marboxil,Favipiravir, and Lopinavir-Ritonavir in 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18-75周岁,性别不限,自愿签署知情同意书。 (2)确诊为新型冠状病毒感染者:呼吸道标本或血液标本实时荧光 RT-PCR 检测新型冠状病毒核酸阳性;或呼吸道标本或血液标本病毒基因测序,与已知的新型冠状病毒高度同源。 (3)症状发作与随机入组的时间间隔在96小时以内:症状发作定义为患者出现至少一种全身性症状(如发热或寒战、头痛、乏力、肌肉或关节疼痛、腹泻等)、呼吸症状(如咳嗽、喉咙痛、鼻塞、流涕)或发热的时间。 (4)吞咽口服药物无困难。 (5)根据研究者的判断患者有能力遵循研究方案。 

Inclusion criteria

1. Aged 18 to 75 years male or female, willing to sign the informed consent; 2. Tested positive for novel coronavirus infection after the onset of symptoms using a real time polymerase chain reaction (RT-PCR)-based diagnostic assay; 3. Enrollment and initiation of study drug treatment <=96 hours after onset of symptoms; 4. No difficulty in swallowing the pills; 5. Willing to abide by the protocol. 

排除标准:

(1)过敏体质,已知对研究药物或药物辅料过敏者。 (2)患者体重<40 kg。 (3)符合以下情况之一的危重症:出现呼吸衰竭,且需要机械通气;出现休克;合并其他器官功能衰竭需 ICU 监护治疗。 (4)已知患有肾功能受损者(估计肌酐清除率<60 mL/min(男性:Cr(ml/min)=(140-年龄)×体重(kg)/72×血肌酐浓度(mg/dl);女性:Cr(ml/min)=(140-年龄)×体重(kg)/85×血肌酐浓度(mg/dl))。 (5)在筛选期间或筛选前24小时内检出患者出现以下任何实验室参数异常(根据当地实验室参考范围): - ALT或AST 水平> 5倍正常范围上限(ULN)或 - ALT或AST 水平> 3倍ULN 且总胆红素水平> 2 倍ULN。 (6)处于妊娠或哺乳期,或给药前检查时妊娠试验阳性,或计划在研究治疗后3个月内怀孕。 

Exclusion criteria:

1. Hypersensitive to study drug; 2. Body weight <40 kg; 3. Considered as severe disease: has an ongoing respiratory deficiency and subjected to invasive mechanical ventilation; or presence of shock; or admitted to the ICU due to complications; 4. Has known kidney dysfunction determined as CLcr<60 mL/min; 5. Increase in alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is more than 5 times the upper limit of normal; or increase in ALT or AST is more than 3 ULN and increase in total bilirubin more than 2 ULN; 6. Pregnancy or breastfeeding,or positive pregnancy test in a predose examination, or have a plan to be pregnant within 3 months after the study. 

研究实施时间:

Study execute time:

From2020-02-04To 2020-06-03 

干预措施:

Interventions:

组别:

A

样本量:

10

Group:

A

Sample size:

干预措施:

巴洛沙韦酯片:每次80mg;第1天和第4天给药,对于在第5天根据特定标准判定为未改善的患者,可于第7天再次给药,总共最多三次给药。

干预措施代码:

Intervention:

BaloxavirMarboxil:80mg on day1,80mg on day4;and 80mg on day7 as neccessary. No more than 3 times administration in total.BaloxavirMarboxil:80mg on day1,80mg on day4;and 80mg on day7 as neccessary. No more than 3 times administration in total.

Intervention code:

组别:

B

样本量:

10

Group:

B

Sample size:

干预措施:

法匹拉韦片:每次 600mg,1 日3次,第1天首次给药1600mg,口服给药,给药时长不超过14天。

干预措施代码:

Intervention:

Favipiravir: 600 mg tid with 1600mg first loading dosage for no more than 14 days.

Intervention code:

组别:

C

样本量:

10

Group:

C

Sample size:

干预措施:

洛匹那韦利/托那韦片(克力芝)片:200mg/50 mg 1片,一次2片,每日2次,连续口服14天。

干预措施代码:

Intervention:

Lopinavir-Ritonavir: 2# (200mg/50 mg), twice daily, for 14days.

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:

Zhejiang 

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 

测量指标:

Outcomes:

指标中文名:

病毒学治疗指标:基于RT-PCR判定的至病毒排毒停止时间

指标类型:

主要指标 

Outcome:

Time to viral negativityby RT-PCR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床疗效指标:至临床改善的时间:定义为至出院时间或至NEWS<2 维持24小时的时间,以先发生者为准。

指标类型:

主要指标 

Outcome:

Time to clinical improvement: Time from start of study drug to hospital discharge or to NEWS2<2 for 24 hours.

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第7天、14天机械通气的发生率

指标类型:

次要指标 

Outcome:

Incidence of mechanical ventilation by day7, day14

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第7天、14天入住ICU的发生率

指标类型:

次要指标 

Outcome:

Incidence of ICU admission by day7, day14

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

从基线至临床治疗失败的时间,定义为至死亡、机械通气或入住ICU的时间

指标类型:

次要指标 

Outcome:

Time to treatment failure, determined as death, mechanical ventilation or ICU 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:

第14天、28天的全因死亡率

指标类型:

次要指标 

Outcome:

All-cause mortality by day14, day28

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

相关并发症的发生率

指标类型:

次要指标 

Outcome:

Incidence of complications

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗生素治疗的使用率和持续时间

指标类型:

次要指标 

Outcome:

Incidence and duration of antibiotic treatment

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第7天、第14天通过RT-PCR检出病毒阳性的患者比例

指标类型:

次要指标 

Outcome:

The number (proportion) of subjects with viral positiveby RT-PCR by day7, day14

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

根据AE评估、临床实验室评估、ECG、生命体征等评估的安全性和耐受性

指标类型:

次要指标 

Outcome:

Safety assessment according to AE, clinical laboratory examination, ECG and vital signs, etc.

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:

尚未开始

Not yet 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):

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。以SAS软件(9.4或以上版本)产生随机号以及随机号所对应治疗组别。受试者筛选合格以后,研究人员根据入组顺序分配一个受试者编号即随机号,根据随机号拆除随机信封,根据随机信封组别和治疗方案给予受试者发放相应药物治疗。

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. SAS software (version 9.4 or above) was used to generate the random number and the treatment group corresponding to the random number. After the subjects passed the screening, the rese

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):

浙江大学医学院附属第一医院

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

The First Affiliated Hospital, Zhejiang University School of Medicine

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:

将由接受过培训的研究者和研究医生采集所有数据。然后将数据录入电子病例报告表(eCRF)中并进入电子数据库中。研究者负责确保录入采集数据的完整、准确与及时记录。数据管理员对数据进行核查,发出疑问,由研究者进行答疑或/和作出必要的数据修改,修改的内容将如实记录在EDC中。在数据录入与核查结束后,由数据管理人员、主要研究者、申办者、统计分析人员共同对数据进行审核,并完成分析人群的最后定义及判断。

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 trained researchers and research doctors. The data is then entered into the electronic case report form (eCRF) and into the electronic database. The researchers are responsible for ensuring the integrity, accuracy and timely recording of the data collected. The data administrator checks the data, issues questions, answers questions or / and makes necessary data modifications, which will be recorded in EDC truthfully. After the completion of data entry and verification, data management personnel, main researchers, sponsors and statistical analysts shall jointly review the data, and complete the final definition and judgment of the analysis population.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-04
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