Today is 2020-11-25

A randomized, open-label, controlled trial for the efficacy and safety of Farpiravir Tablets in the treatment of patients with novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000029996 

最近更新日期:

Date of Last Refreshed on:

2020-02-21 

注册时间:

Date of Registration:

2020-02-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项评价法匹拉韦片在普通型新型冠状病毒肺炎 (COVID-19) 患者中的有效性、安全性的随机、开放、剂量探索的临床研究 

Public title:

A randomized, open-label, controlled trial for the efficacy and safety of Farpiravir Tablets in the treatment of patients with novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一项评价法匹拉韦片在普通型新型冠状病毒肺炎 (COVID-19) 患者中的有效性、安全性的随机、开放、剂量探索的临床研究 

Scientific title:

A randomized, open-label, controlled trial for the efficacy and safety of Farpiravir Tablets in the treatment of patients with 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:

聂朝宏 

研究负责人:

童朝晖 

Applicant:

Zhaohong Nie 

Study leader:

Zhaohui Tong 

申请注册联系人电话:

Applicant telephone:

+86 18920225737 

研究负责人电话:

Study leader's telephone:

+86 13910930309 

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:

niezhaohong@sihuanpharm.com 

研究负责人电子邮件:

Study leader's E-mail:

13910930309@163.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):

 

申请注册联系人通讯地址:

北京市朝阳区八里庄街道朝阳路住邦2000 4号楼8层809室 

研究负责人通讯地址:

北京市朝阳区工人体育场南路8号 

Applicant address:

Room 809, 8th Floor, Building 4, Zhubang 2000, Chaoyang Road, Balizhuang Street, Chaoyang District, Beijing 

Study leader's address:

8 Workers Stadium Road South, Chaoyang District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100025 

研究负责人邮政编码:

Study leader's postcode:

100000 

申请人所在单位:

北京四环制药有限公司 

Applicant's institution:

Beijing Sihuan Pharmaceutical Co., Ltd. 

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-科-21-1 

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:

首都医科大学附属北京朝阳医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Beijing Chaoyang Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-17 

伦理委员会联系人:

吕亚丽 

Contact Name of the ethic committee:

Yali Lv 

伦理委员会联系地址:

北京市朝阳区工体东路16号 

Contact Address of the ethic committee:

16 Workers Stadium Road East, Chaoyang District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010-85231484 

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:

首都医科大学附属北京朝阳医院 

Primary sponsor:

Beijing Chaoyang Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市朝阳区工人体育场南路8号 

Primary sponsor's address:

8 Workers Stadium Road South, Chaoyang District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京朝阳医院

具体地址:

朝阳区工人体育场南路8号

Institution
hospital:

Beijing Chaoyang Hospital, Capital Medical University

Address:

8 Workers Stadium Road South, Chaoyang District

经费或物资来源:

自筹 

Source(s) of funding:

Self-raised 

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:

II期临床试验 

Study phase:

研究目的:

主要目的:初步评价法匹拉韦片治疗普通型新型冠状病毒肺炎(NCP)患者的疗效。 次要目的:初步评价法匹拉韦片在普通型新型冠状病毒肺炎(NCP)患者中的安全性。 

Objectives of Study:

Primary objective: To initially evaluate the efficacy of Fapilavir Ttablets in the treatment of patients with ordinary Novel coronavirus pneumonia (NCP). Secondary objective: To initially evaluate the safety of Fapilavir Tablets in patients with ordinary Novel coronavirus pneumonia (NCP). 

药物成份或治疗方案详述:

本品主要成份为法匹拉韦;一日两次给药,整个治疗疗程为10天。 

Description for medicine or protocol of treatment in detail:

The main ingredient of this product is fapilavir. Dosing twice a day, the duration of treatment will be 10 d. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 自愿签署知情同意书; 2. 年龄在18周岁及以上的男性或女性; 3. 参照《新型冠状病毒感染的肺炎诊疗方案-试行第五版》诊断的确诊病例并且临床分型为普通型的新冠肺炎住院患者:具有发热(腋下体温≥37.0℃)、呼吸道等症状,影像学可见肺炎表现。 

Inclusion criteria

1. Voluntarily sign the Consent Form; 2. Male or female aged 18 and over; 3. According to the "Diagnosis and Treatment Scheme for Pneumonia of Novel coronavirus pneumonia Infection-Trial Fifth Edition", inpatient diagnosed with Novel coronavirus pneumonia diagnosed and clinical classification of ordinary type: Inpatients with fever (underarm temperature >= 37.0 degree C), respiratory tract, etc. Imaging shows pneumonia. 

排除标准:

1. 妊娠或可能妊娠的女性,或不能停止哺乳的哺乳期女性,或在筛选时检查中妊娠试验阳性的女性; 2. 从签署知情同意书至末次给药后90天内有生育计划或不愿意采取可靠避孕措施进行避孕的男性或女性; 3. 研究者认为不适合参与本项研究的其它情况。 

Exclusion criteria:

1. Females who are pregnant or likely to be pregnant, or who are lactating and unable to stop breastfeeding, or who have positive pregnancy tests during screening; 2. Males or females who have a birth plan or are unwilling to take reliable contraceptive measures for contraception within 90 days from signing the informed consent to the last dose; 3. Other circumstances that the researchers consider inappropriate for participation in this study. 

研究实施时间:

Study execute time:

From2020-02-20To 2020-04-20 

征募观察对象时间:

Recruiting time:

From2020-02-20To 2020-03-06 

干预措施:

Interventions:

组别:

低剂量组

样本量:

20

Group:

Low-dose group

Sample size:

干预措施:

片剂;200mg;口服;一日两次;成人首日用药剂量为每次1600mg;整个治疗疗程为10天。

干预措施代码:

Intervention:

Tablets; 200mg; oral; twice a day; The adult dose is 1600 mg per time on first day; the duration of treatment will be 10 d.

Intervention code:

组别:

中剂量组

样本量:

20

Group:

Middle-dose group

Sample size:

干预措施:

片剂;200mg;口服;一日两次;成人首日用药剂量为每次1800mg;整个治疗疗程为10天。

干预措施代码:

Intervention:

Tablets; 200mg; orally; twice a day;The adult dose is 1800 mg per time on first day; the duration of treatment will be 10 d.

Intervention code:

组别:

高剂量组

样本量:

20

Group:

High-dose group

Sample size:

干预措施:

片剂;200mg;口服;一日两次;成人首日用药剂量为每次2400mg;整个治疗疗程为10天。

干预措施代码:

Intervention:

Tablets; 200mg; oral; twice a day; The adult dose is 2400 mg per time on first day; the duration of treatment will be 10 d.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京朝阳医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Chaoyang Hospital, Capital Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

临床恢复时间(TTCR)

指标类型:

主要指标 

Outcome:

Time to Clinical Recovery

Type:

Primary indicator 

测量时间点:

观察至出院或者转为重症

测量方法:

从开始研究治疗到体温转为正常(腋下体温≤36.9℃)以及咳嗽缓解(以咳嗽症状积分量表评估受试者的咳嗽程度),持续至少72小时的时间(72小时的观察期内不能使用解热药,并以小时为单位)。

Measure time point of outcome:

Observation until discharge or turn to severe

Measure method:

Duration of at least 72 hours from the start of study treatment to normal body temperature (underarm temperature <= 36.9 degrees C) and cough relief (evaluated by the cough symptom score scale) Use antipyretics, and in hours).

指标中文名:

普通型新型冠状病毒肺炎进展为重型的发生率

指标类型:

次要指标 

Outcome:

The incidence of common Novel coronavirus pneumonia progressing to severe

Type:

Secondary indicator 

测量时间点:

首次用药后第5天、第10天以及出院或转为重症

测量方法:

符合下列任何一条的新冠肺炎患者即为重症患者:呼吸窘迫,RR≥30次/分;静息状态下,指氧饱和度≤93%;动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg。

Measure time point of outcome:

On the 5th, 10th day after the first dose, and discharge or turn to severe

Measure method:

Patients with Novel coronavirus pneumonia who meet any of the following are severe patients: respiratory distress, RR ≥30 beats / min; in a resting state, means oxygen saturation ≤93%; arterial blood oxygen pressure (PaO2) / oxygen concentration (FiO2) ) ≤300mmHg.

指标中文名:

解除隔离和出院时间

指标类型:

次要指标 

Outcome:

Release and quarantine time

Type:

Secondary indicator 

测量时间点:

测量方法:

体温恢复正常3天以上、呼吸道症状明显好转,肺部影像学显示炎症明显吸收,连续两次呼吸道病原核酸检测阴性(采样时间间隔至少1天)

Measure time point of outcome:

Measure method:

Body temperature returned to normal for more than 3 days, respiratory symptoms improved significantly, pulmonary imaging showed obvious absorption of inflammation, and two consecutive respiratory pathogen nucleic acid detection are negative (sampling time interval of at least 1 day)

指标中文名:

普通型新冠肺炎进展为重型的时间

指标类型:

次要指标 

Outcome:

Time when common Novel coronavirus pneumonia progress to severe

Type:

Secondary indicator 

测量时间点:

测量方法:

符合下列任何一条的新冠肺炎患者即为重症患者:呼吸窘迫,RR≥30次/分;静息状态下,指氧饱和度≤93%;动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg。

Measure time point of outcome:

Measure method:

Patients with Novel coronavirus pneumonia who meet any of the following are severe patients: respiratory distress, RR >= 30 beats / min; in a resting state, means oxygen saturation <= 93%; arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <= 300mmHg.

指标中文名:

进入ICU的比率

指标类型:

次要指标 

Outcome:

Proportion to ICU

Type:

Secondary indicator 

测量时间点:

首次用药后第5天、第10天以及出院或转为重症

测量方法:

Measure time point of outcome:

On the 5th, 10th day after the first dose, and discharge or turn to severe

Measure method:

指标中文名:

机械通气率

指标类型:

次要指标 

Outcome:

Mechanical ventilation rate

Type:

Secondary indicator 

测量时间点:

首次用药后第5天、第10天以及出院或转为重症

测量方法:

Measure time point of outcome:

On the 5th, 10th day after the first dose, and discharge or turn to severe

Measure method:

指标中文名:

死亡率

指标类型:

次要指标 

Outcome:

mortality rate

Type:

Secondary indicator 

测量时间点:

首次用药后第5天、第10天以及出院或转为重症

测量方法:

Measure time point of outcome:

On the 5th, 10th day after the first dose, and discharge or turn to severe

Measure method:

指标中文名:

主要临床表现消退时间(发热、干咳、乏力)

指标类型:

次要指标 

Outcome:

Time for the main clinical manifestations to subside (fever, dry cough, fatigue)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发热持续时间

指标类型:

次要指标 

Outcome:

Duration of fever

Type:

Secondary indicator 

测量时间点:

测量方法:

腋下体温降到36.9℃以下所用的时间

Measure time point of outcome:

Measure method:

Time taken for armpit temperature to drop below 36.9 degrees C

指标中文名:

病毒载量随时间的变化

指标类型:

次要指标 

Outcome:

Changes in viral load over 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:

病毒转阴的时间

指标类型:

次要指标 

Outcome:

Time for the virus to turn negative

Type:

Secondary indicator 

测量时间点:

测量方法:

至连续两次核酸检测(采样时间至少间隔1天)为阴性的时间

Measure time point of outcome:

Measure method:

Time until two consecutive nucleic acid detection (sampling time interval of at least 1 day) are negative.

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

肺泡灌洗液

组织:

Sample Name:

Alveolar lavage fluid

Tissue:

lung

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:

呼吸道

Sample Name:

Sputum

Tissue:

Respiratory tract

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:

咽峡部

Sample Name:

Throat swab

Tissue:

Pharyngeal isthmus

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:

血样

组织:

静脉

Sample Name:

Blood sample

Tissue:

vein

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:

肛门拭子

组织:

肛门

Sample Name:

Anal swab

Tissue:

anus

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):

本试验将由统计人员采用动态随机方法

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

This trial will use a dynamic random approach by statisticians

盲法:

开放

Blinding:

open label

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

公开原始数据时间2021年6月1日,方式为电子数据

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

data posting date planned on Jun.1,2021, using electronic data

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:

数据管理工作将由申办方或指定的数据管理供应商负责执行。 本研究将使用电子数据采集(EDC)系统。研究中心的所有临床试验数据均将以电子格式录入eCRF。数据的采集,包括所有录入、纠正和更改均由研究者或研究者指定的研究中心授权工作人员进行。监查员不能录入数据到eCRF。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Data management will be performed by the sponsor or the designated data management vendor. This study will use an electronic data acquisition (EDC) system. All clinical trial data from the research center will be entered into eCRF in electronic format. Data collection, including all entries, corrections, and changes, was performed by the researcher or authorized staff of the research center designated by the researcher. Auditors cannot enter data into eCRF.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-20
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