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痰热清胶囊治疗新型冠状病毒肺炎 (COVID-19) 临床试验
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注册号:

Registration number:

ChiCTR2000029813 

最近更新日期:

Date of Last Refreshed on:

2020-02-14 

注册时间:

Date of Registration:

2020-02-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

痰热清胶囊治疗新型冠状病毒肺炎 (COVID-19) 临床试验 

Public title:

Clinical Trial for Tanreqing Capsules in the Treatment 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:

痰热清胶囊治疗新型冠状病毒肺炎 (COVID-19) 临床试验 

Scientific title:

Clinical Trial for Tanreqing Capsules in the Treatment 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:

ChiMCTR2000003012 

申请注册联系人:

陈晓蓉 

研究负责人:

卢洪洲/陈晓蓉 

Applicant:

Xiaorong Chen 

Study leader:

Hongzhou Lu, Xiaorong Chen 

申请注册联系人电话:

Applicant telephone:

+86 18930817533 

研究负责人电话:

Study leader's telephone:

+86 18930810088 

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:

xiaorong3chen@163.com 

研究负责人电子邮件:

Study leader's E-mail:

luhongzhou@fudan.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:

上海市金山区漕廊公路2901号 

研究负责人通讯地址:

上海市金山区漕廊公路2901号 

Applicant address:

2901 Caolang Road, Jinshan District, Shanghai 

Study leader's address:

2901 Caolang Road, Jinshan District, Shanghai 

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:

上海市公共卫生临床中心 

Applicant's institution:

Shanghai Public Health Clinical Center 

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:

YJ-2020-E004-01 

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:

上海市公共卫生临床中心医学伦理委员会 

Name of the ethic committee:

Shanghai Public Health Clinical Center Ethics Committee  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-12 

伦理委员会联系人:

沈洁 

Contact Name of the ethic committee:

Jie Shen 

伦理委员会联系地址:

上海市金山区漕廊公路2901号,上海市公共卫生临床中心防控东楼313室 

Contact Address of the ethic committee:

2901 Caolang Road, Jinshan District, Shanghai 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021-37990333-8349 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

lunliweiyuanhui2009@126.com 

研究实施负责(组长)单位:

上海市公共卫生临床中心 

Primary sponsor:

Shanghai Public Health Clinical Center 

研究实施负责(组长)单位地址:

上海市金山区漕廊公路2901号 

Primary sponsor's address:

2901 Caolang Road, Jinshan District, Shanghai 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市公共卫生临床中心

具体地址:

金山区漕廊公路2901号

Institution
hospital:

Shanghai Public Health Clinical Center

Address:

2901 Caolang Road, Jinshan District

经费或物资来源:

上海市发展和改革委员会 

Source(s) of funding:

Shanghai Municipal Development & Reform Commission 

研究疾病:

新型冠状病毒肺炎 

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:

评价痰热清胶囊治疗新型冠状病毒肺炎的有效性及安全性。 

Objectives of Study:

To evaluate the efficacy and safety of Tanreqing Capsules in the treatment of pneumonia caused by novel coronavirus.  

药物成份或治疗方案详述:

1 常规治疗 (1) 隔离治疗:疑似及确诊病例应在具备有效隔离条件和防护条件的定点医院隔离治疗,疑似病例应单人单间隔离治疗,确诊病例可多人收治在同一病室。危重型病例应尽早收入 ICU治疗。 (2) 一般治疗: ① 卧床休息,加强支持治疗,保证充分热量;注意水、电解质平衡,维持内环境稳定;密切监测生命体征、指氧饱和度等。 ② 根据病情监测血常规、尿常规、CRP、生化指标(肝酶、心肌酶、肾功能等)、凝血功能,动脉血气分析,胸部影像学等。有条件者可行细胞因子检测。 ③ 及时给予有效氧疗措施,包括鼻导管、面罩给氧和经鼻高流量氧疗。 ④ 抗病毒治疗:目前没有确认有效的抗病毒治疗方法。可试用α-干扰素雾化吸入(成人每次500万U或相当剂量,加入灭菌注射用水2ml,每日2次)、洛匹那韦/利托那韦(200 mg/50mg,每粒)每次2粒,每日2次,或可加用利巴韦林(成人首剂4g,次日8小时一次,每次1.2g,或8mg/Kg iv.每8小时一次)。要注意洛匹那韦/利托那韦相关腹泻、恶心、呕吐、肝功能损害等不良反应,同时要注意和其它药物的相互作用。 ⑤ 抗菌药物治疗:避免盲目或不恰当使用抗菌药物,尤其是联合使用广谱抗菌药物。 2 试验治疗 (1) 试验组:常规治疗+痰热清胶囊(口服,一次3粒,每日3次)。 (2) 对照组:常规治疗。 3 用药时限 用药时限7~14天。 

Description for medicine or protocol of treatment in detail:

1 Conventional Treatment (1) Isolation Treatment: Suspected and confirmed cases should be treated in hospitals with effective isolation and protection conditions. Suspected cases should be treated in isolation in a single room. Confirmed cases can occupy same room. Critical cases should be admitted to ICU as soon as possible. (2) General Treatment 1) Patient should rest in bed ,given strengthen supportive treatment, and ensured with sufficient heat; special attention needs to be given to water and electrolyte balance and maintenance internal environment stability; vital signs and oxygen saturation need to be closely monitored. 2) Blood routine, urine routine, CRP, biochemical indicators (liver enzyme, myocardial enzyme, kidney function, etc.), coagulation function, arterial blood gas analysis, chest imaging, etc. should be monitored according to the condition. Cytokine analysis need to be conducted if conditions allows. 3) Effective oxygen therapy measures should be given in time, including nasal cannula, mask oxygen supply and trans-nasal high-flow oxygen therapy. 4) Antiviral therapy: At present, no confirmed effective antiviral therapy is available. Try alpha-interferon inhalation (5 million U or equivalent per adult, add 2ml of sterile water for injection twice daily), lopinavir / ritonavir (200 mg / 50mg, each capsule ) 2 capsules, 2 times daily, or ribavirin (the first dose for adults 4g, 8 hours the next day, 1.2g each time, or 8mg / Kg iv. once every 8 hours). Pay attention to adverse events such as diarrhea, nausea, vomiting, and liver damage related to lopinavir / ritonavir, and pay attention to other drug interactions. 5) Antibacterial treatment: Avoid blind or inappropriate use of antibacterial drugs, especially the combination of broad-spectrum antibacterial drugs. 2 Study Treatment (1) Treatment group: conventional treatment + Tanreqing Capsules (oral, 3 capsules at a time, 3 times a day). (2) Control group: conventional treatment. 3 Treatment Duration Treatment duration should be within 7-14 days. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1) 符合新型冠状病毒肺炎诊断,且临床分型为轻型和普通型者; (2) 中医辩证为疫毒闭肺者; (3) 年龄在18~75周岁的住院病人,男女不限; (4) 自愿接受该药治疗,并签署知情同意书。知情同意过程符合GCP有关规定。 

Inclusion criteria

(1) Those who meet the diagnosis of new coronavirus pneumonia and have clinical classification of low and medium; (2) Those who have been diagnosed with TCM as epidemic-closed lungs; (3) Inpatients aged 18 to 75 years, regardless of gender; (4) Voluntarily receive treatment with the drug and sign informed consent. The informed consent process complies with relevant GCP regulations. 

排除标准:

(1) 免疫缺陷疾病,或近3个月内使用免疫抑制剂或糖皮质激素者。 (2) 准备妊娠者、孕妇及哺乳期妇女。 (3) 过敏体质者(指对两种以上的药品或食品过敏或本次试验用药已知成份过敏)。 (4) 精神病患者,或无自知能力者。 (5) 从筛选开始预计生存时间不超过48小时的患者。 (6) 筛选时已经气管插管或机械通气者。 (7) 心、肝、肾或其他各种系统明显症状,ALT、AST超过正常值上限的1.5倍。 (8) 研究者认为有不适宜参加临床试验者。 

Exclusion criteria:

(1) Immunodeficiency disease, or those who have used immunosuppressive agents or glucocorticoids within the past 3 months; (2) Preparing pregnant, pregnant and lactating women; (3) Patients with allergies (referring to allergies to two or more medicines, foods or known ingredients in this study); (4) Patients with mental illness, or have no cognitive ability; (5) Patients with an estimated survival time of less than 48 hours from the start of screening; (6) Those who have been intubated or mechanically ventilated at the time of screening; (7) Obvious symptoms of heart, liver, kidney or various other systems, ALT, AST exceed 1.5 times the upper limit of normal value; (8) Believed to be not suitable to participate in clinical trials by investigator. 

研究实施时间:

Study execute time:

From2020-02-14To 2020-08-14 

干预措施:

Interventions:

组别:

试验组

样本量:

36

Group:

Experimental group

Sample size:

干预措施:

常规治疗+痰热清胶囊(口服,一次3粒,每日3次)

干预措施代码:

Intervention:

Conventional Treatment & Tanreqing Capsules (oral, 3 capsules at a time, 3 times a day)

Intervention code:

组别:

对照组

样本量:

36

Group:

Control Group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Conventional Treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市公共卫生临床中心 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Public Health Clinical Center  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

病毒核酸转阴时间

指标类型:

主要指标 

Outcome:

Time of viral nucleic acid turns negative

Type:

Primary indicator 

测量时间点:

受试者病情明显改善后进行2次或2次以上新型冠状病毒肺炎病毒核酸检测(间隔24小时以上),连续2次阴性,以第1次检测结果阴性时间为转阴时间。

测量方法:

Measure time point of outcome:

After the subject's condition is significantly improved, two or more new coronavirus pneumonia virus nucleic acid tests (with an interval of more than 24 hours) are performed, and the test is negative for two consecutive times. The negative time is the time when the first test result is negative.

Measure method:

指标中文名:

退热时间

指标类型:

主要指标 

Outcome:

Antipyretic time

Type:

Primary indicator 

测量时间点:

治疗期间于每天8时、12时、16时、20时各观测1次。

测量方法:

Measure time point of outcome:

Observe once every day during the treatment period at 8 o'clock, 12 o'clock, 16 o'clock, and 20 o'clock.

Measure method:

指标中文名:

指氧饱和度

指标类型:

次要指标 

Outcome:

Arterial Oxygen Saturation

Type:

Secondary indicator 

测量时间点:

于入组时及用药后每天6时、14时各检测1次。

测量方法:

Measure time point of outcome:

Measured once at the time of enrollment and at 6 o'clock and 14 o'clock each day after administration.

Measure method:

指标中文名:

重症(重型或危重型)转化率

指标类型:

次要指标 

Outcome:

Critical (severe or critical) conversion 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:

炎症指标(CRP)

指标类型:

次要指标 

Outcome:

Inflammation index (CRP)

Type:

Secondary indicator 

测量时间点:

于入组时及用药后第3、7、14天各检测1次(共4次)。

测量方法:

Measure time point of outcome:

Once at the time of enrollment and 3, 7, and 14 days after administration (4 times in total).

Measure method:

指标中文名:

咳嗽症状的消失率以及消失时间

指标类型:

次要指标 

Outcome:

The disappearance rate and time of cough symptoms

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床痊愈时间

指标类型:

次要指标 

Outcome:

Clinical recovery time

Type:

Secondary indicator 

测量时间点:

体温恢复正常3天以上、呼吸道症状明显好转,连续两次病毒核酸检测阴性时间。

测量方法:

Measure time point of outcome:

Time of body temperature returns to normal for more than 3 days, the respiratory symptoms improve significantly, and the viral nucleic acid test is negative twice in a row.

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:

尿液

组织:

Sample Name:

Urine

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:

大便

组织:

Sample Name:

Stool

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):

采用区组随机化方法。运用专业统计软件分别产生2组共72例受试者所接受处理(试验组和对照组)的随机表,即流水号为001~072所对应的治疗分配表。

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

Block randomization method will be used. The professional statistical software will be used to generate a random list of treatments (treatment group and control group) for a total of 72 subjects, that is, the treatment allocation table corresponding to the serial number 001-072.

盲法:

开放

Blinding:

Open label

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

上海市公共卫生临床中心

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

Shanghai Public Health Clinical Center

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:

(1) 本试验采用百奥知电子数据采集系统(EDC)创建电子病例报告表(下称:eCRF),通过互联网登陆在线进行数据采集与管理。 中心指定的数据录入相关人员通过互联网登录电子数据采集系统(EDC),按访视时点及时录入试验数据。eCRF不作为原始记录,其内容源于研究病历等原始记录。 (2) 数据锁定:所有病例数据全部录入完成后,有关数据管理人员进行数据的逻辑检查,最后完成《数据管理报告》,由主要研究者、申办单位代表、统计分析人员等对数据进行最后审核,并按统计分析计划书划分分析人群后对数据库进行锁定,交统计分析人员进行统计分析。锁定后的数据文件不可再做改动。数据锁定之后发现的问题,经确认后可在统计分析程序中进行修正。

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

(1) This study adopts Bioknow electronic data capture system (EDC) to create electronic case report form (eCRF), data collection and management are conducted through the Internet. Data entry related personnel at site entry study data using EDC, the data should be originate from Research Medical Records. (2) Data Lock: After entry completion of all relevant data, data manager will conduct logic check to check the data, and complete "Data Management Report". Principal investigator, sponsor, and statistician will conduct data review, and divide the analysis population according to the statistical analysis plan. After data review, data manager will lock the database and hand data over to the statistical analysts for statistical analysis. The locked data file cannot be changed. The problems found after the data is locked can be corrected in the statistical analysis program after confirmation.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-14
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