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A Randomized, Double-blind, Placebo-controlled trial for determination of the Efficacy and Safety of Baicalein in Hospitalized Adult Mild and Moderate Patients of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000033286 

最近更新日期:

Date of Last Refreshed on:

2020-05-26 

注册时间:

Date of Registration:

2020-05-26 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

一项评价百可利(BAICALEIN)治疗住院成人新型冠状病毒肺炎(COVID-19)轻型-普通型患者疗效和安全性的随机、双盲、安慰剂对照的研究 

Public title:

A Randomized, Double-blind, Placebo-controlled trial for determination of the Efficacy and Safety of Baicalein in Hospitalized Adult Mild and Moderate Patients 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:

一项评价百可利(BAICALEIN)治疗住院成人新型冠状病毒肺炎(COVID-19)轻型-普通型患者疗效和安全性的随机、双盲、安慰剂对照的研究 

Scientific title:

A Randomized, Double-blind, Placebo-controlled trial for determination of the Efficacy and Safety of Baicalein in Hospitalized Adult Mild and Moderate Patients 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:

王朝庆 

研究负责人:

曾宪升 

Applicant:

Chaoqing Wang 

Study leader:

Xiansheng Zeng 

申请注册联系人电话:

Applicant telephone:

+86 15856966662 

研究负责人电话:

Study leader's telephone:

+86 0710-3516703 

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:

wangcq_jxyy@163.com 

研究负责人电子邮件:

Study leader's E-mail:

310355055@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):

 

申请注册联系人通讯地址:

合肥市高新区科学大道103号浙商创业大厦A幢410室 

研究负责人通讯地址:

湖北省襄阳市襄城荆州街39号 

Applicant address:

Room 410, Building A, Zheshang entrepreneurship Building, 103 Science Avenue, high-tech zone, Hefei, Anhui, China 

Study leader's address:

39 Jingzhou Street, Xiangcheng District, Xiangyang, Hubei, 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:

合肥聚信医药科技有限公司 

Applicant's institution:

Juxin Pharmaceutical Technology 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:

XYSZXYY-LL-PJ-2020-001 

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:

襄阳市中心医院医学伦理委员会 

Name of the ethic committee:

The Medical Ethics Committee of Xiangyang General Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-15 

伦理委员会联系人:

程瑾 

Contact Name of the ethic committee:

Jin Cheng 

伦理委员会联系地址:

湖北省襄阳市荆州街139号襄阳市中心医院行政楼5楼科研处办公室 

Contact Address of the ethic committee:

Scientific Research Office, 5th floor, administration building, Xiangyang Central Hospital, 139 Jingzhou Street, Xiangyang, Hubei, 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:

湖北省襄阳市中心医院 

Primary sponsor:

Xiangyang Central Hospital 

研究实施负责(组长)单位地址:

湖北省襄阳市襄城荆州街136号 

Primary sponsor's address:

136 Jingzhou Street, Xiangcheng, Xiangyang, Hubei, 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):

湖北省

市(区县):

Country:

China

Province:

Hubei

City:

单位(医院):

中国医学科学院药物研究所

具体地址:

北京市西城区先农坛街一号

Institution
hospital:

Institute of Materia Medica, Chinese Academy of Medical Sciences

Address:

1 Xiannongtan Street, Xicheng District, Beijing

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:

其它 

Study phase:

N/A 

研究目的:

评价与标准治疗(SOC)相比,使用百可利+SOC治疗成人新型冠状病毒轻型-普通型肺炎患者的疗效和安全性。 

Objectives of Study:

To evaluate the efficacy and safety of Bicole + SOC in the treatment of adult patients with novel Coronavirus mild-to-moderate Pneumonia as compared with standard therapy (SOC) . 

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.成人(定义为年龄≥ 18 岁); 2.经过PCR确证的新型冠状病毒感染患者或者新型冠状病毒特征感染肺炎特征的CT改变; 3.住院患者,伴有发热(腋温>37℃)或咳嗽、呼吸困难; 4.症状发作与随机入组之间的时间间隔在8天以内; 5.同意参加本研究并接受随机分组; 6.签署知情同意书前3个月内未参加过药物临床试验者。 

Inclusion criteria

1. Adults (defined as those aged >=18 years) ; 2. The CT findings of patients with novel coronavirus infection or pneumonia confirmed by PCR; 3. In-patients, accompanied by fever (Temperature at Armpit > 37 degree C) or cough, dyspnea; 4. The interval between symptom onset and randomization was less than 8 days; 5. Agree to participate in the study and accept the randomization; 6. Who has not participated in a drug clinical trial within 3 months prior to signing the informed consent form. 

排除标准:

1.医生判断参与研究不符合患者权益,或其他任何不能让方案安全进行的情况; 2.严重肝病,有肝硬化基础疾病或谷丙转氨酶(ALT)/谷草转氨酶(AST)升高超过正常上限5倍; 3.严重肾功能损坏(估算的肾小球滤过率≤30ml/min/1.73m2),或接受持续肾脏修复治疗、血液透析、腹膜透析; 4.静息未吸氧状态下,患者SPO2≤93%,或氧合指数小于300mmHg; 5.对百可利已知过敏或超敏反应; 6.妊娠:育龄女性妊娠试验阳性或哺乳期女性; 7.患者可能在 72h 内转至非参与医院; 8.未签署知情同意; 9.已使用百可利(Baicalein)或其他截止到入组评估30天内参加任何2019-nCoV试验性治疗(包括同情使用或试验相关)的患者。 

Exclusion criteria:

1. The physician determines that participation in the study is not in the patient's interest, or in any other case that does not allow the program to proceed safely; 2. Severe liver disease, underlying cirrhosis or a five-fold increase in Alanine transaminase Aspartate transaminase; 3. Severe impairment of Renal Function (estimated glomerular filtration rate <=30 ml / min / 1.73 m2) or continuous renal repair, hemodialysis, peritoneal dialysis; 4. SPO2<=93% , or oxygenation index less than 300 MMHG; 5. Known Allergy or hypersensitivity to Bacoli; 6. Pregnancy: Women of child-bearing age who test positive for pregnancy or breast-feeding; 7. Patients may be transferred to a non-participating hospital within 72 hours. 8.Non-signed informed consent; 9.patients who have used Baicalein or other 2019-nCoV experimental treatment (including compassionate use or trial-related) within 30 days of the induction assessment. 

研究实施时间:

Study execute time:

From2020-02-15To 2020-03-09 

干预措施:

Interventions:

组别:

实验组

样本量:

40

Group:

Experimental Group

Sample size:

干预措施:

百可利咀嚼片,200mg/片,使用剂量200mg/次,一日3次,共600mg/天,总疗程:10天

干预措施代码:

Intervention:

Baicoli chewable tablets, 200mg / tablet, dosage 200mg / Time, 3 times a day, total 600mg / day, total course of treatment: 10 days

Intervention code:

组别:

对照组

样本量:

20

Group:

Control Group

Sample size:

干预措施:

安慰剂200mg/次,一日3次,共600mg/天,总疗程10天

干预措施代码:

Intervention:

Placebo 200 mg / day, 3 times a day, 600 mg / day, for 10 days

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北省 

市(区县):

 

Country:

China 

Province:

Hubei Province 

City:

 

单位(医院):

襄阳市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Xiangyang Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

襄阳市第一人民医院 

单位级别:

三甲医院 

Institution
hospital:

First People's Hospital of Xingyang  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

治疗到临床恢复时间

指标类型:

主要指标 

Outcome:

time to recovery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗到退烧时间(入组时发热的病人)

指标类型:

次要指标 

Outcome:

Treatment-to-fever time (for patients with fever at 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:

治疗到咳嗽缓解的时间(入组时中重度咳嗽的病人)

指标类型:

次要指标 

Outcome:

Time between treatment and remission of cough (patients with moderate to severe cough when admitted)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗到呼吸困难缓解时间(定义为轻度或无呼吸困难,适用于入组时有中度呼吸困难的病人)

指标类型:

次要指标 

Outcome:

Time from treatment to dyspnea relief (defined as mild or no dyspnea, applicable to patients with moderate dyspnea at 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:

14天辅助氧疗或无创机械通气率

指标类型:

次要指标 

Outcome:

14-day supplemental oxygen therapy or non-invasive mechanical ventilation rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗到上呼吸道标本2019-nCoV RT-PCR检测阴性时间

指标类型:

次要指标 

Outcome:

Treatment to upper respiratory tract specimen 2019-nCoV negative time detected by RT-PCR

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

14天全因死亡率

指标类型:

次要指标 

Outcome:

14-day all-cause mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

. 14天呼吸衰竭发生率(定义为不吸氧情况下SPO2≤90%或PaO2/FiO2 <300mmHg且需要氧疗或更高级呼吸支持)

指标类型:

次要指标 

Outcome:

Incidence of aspiration failure at 14 days (defined as SPO2<=90% or PAO2 / FIO2 < 300 mmHg Without Oxygen Therapy or higher respiratory support)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

14天ICU入住率

指标类型:

次要指标 

Outcome:

14-day ICU occupancy rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

14天SAE率

指标类型:

次要指标 

Outcome:

14-day rate of SAE

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:

鼻咽拭子

组织:

口鼻

Sample Name:

Nasopharyngeal swab

Tissue:

nose

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:

征募研究对象情况:

Recruiting status:

结束

Completed

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):

本研究采用中央随机系统(IWRS)随机,为保障分配隐藏,负责随机的人员不得参与患者疾病治疗和预后评估等。随机过程将使得治疗组和空白对照组的患者比例约为2:1。

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

This study uses the interactive web response system(IWRS) to random,in order to ensure that the allocation is hidden,the person responsible for randomization shall not participate in the treatment of patients' diseases and the assessment of prognosis. The randomization process will result in a ratio of approximatel

盲法:

Double blind

Blinding:

Double blind

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):

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

None

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:

数据使用纸质版及电子版进行采集,纸质版保留原始病例记录表,同时采用电子系统进行网上录入。

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

The data is collected in paper and electronic versions. The paper version retains the original case record form and uses an electronic system for online entry.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-05-26
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