Today is 2020-06-06

Clinical study for Celebrex in the treatment of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000031630 

最近更新日期:

Date of Last Refreshed on:

2020-04-05 

注册时间:

Date of Registration:

2020-04-05 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

塞来昔布治疗新型冠状病毒感染者(COVID-19)疗效的临床研究方案 

Public title:

Clinical study for Celebrex 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:

塞来昔布治疗新型冠状病毒感染者(COVID-19)疗效的临床研究方案 

Scientific title:

Clinical study for Celebrex 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:

 

申请注册联系人:

洪文昕 

研究负责人:

洪文昕 

Applicant:

Wenxin Hong 

Study leader:

Hong wenxin 

申请注册联系人电话:

Applicant telephone:

+86 13729834533 

研究负责人电话:

Study leader's telephone:

+86 13729834533 

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:

winsonhong@126.com 

研究负责人电子邮件:

Study leader's E-mail:

winsonhong@126.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:

广州市东风东路627号 

研究负责人通讯地址:

广州市东风东路627号 

Applicant address:

627 Dongfeng Road East, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

627 Dongfeng Road East, Yuexiu District, Guangzhou, Guangdong, 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:

广州市第八人民医院 

Applicant's institution:

Guangzhou Eighth People's Hospital 

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:

202005138 

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:

广州市第八人民医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Guangzhou Eighth People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-04 

伦理委员会联系人:

周蓉 

Contact Name of the ethic committee:

Zhou Rong 

伦理委员会联系地址:

广州市东风东路627号 

Contact Address of the ethic committee:

627 Dongfeng Road East, Yuexiu District, Guangzhou, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 020-36473536 

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:

广州市第八人民医院 

Primary sponsor:

Guangzhou Eighth People's Hospital 

研究实施负责(组长)单位地址:

广州市东风东路627号 

Primary sponsor's address:

627 Dongfeng Road East, Yuexiu District, Guangzhou, Guangdong, 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):

广东

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

广州市第八人民医院

具体地址:

广州市东风东路627号

Institution
hospital:

Guangzhou Eighth People's Hospital

Address:

627 Dongfeng Road East, Yuexiu District, Guangzhou

经费或物资来源:

医院基金 

Source(s) of funding:

Hospital Fund 

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:

探讨塞来昔布治疗新型冠状病毒感染者的疗效,为进一步明确有效安全的治疗方案提供依据。 

Objectives of Study:

To study the effectiveness of novel coronavirus 2019 infection patients treated with Celebrex, and to provide evidence for further effective and safe treatment. 

药物成份或治疗方案详述:

治疗组在常规治疗方案基础上口服塞来昔布胶囊,200mg/次,每天2次;服用7天;对照组常规治疗 

Description for medicine or protocol of treatment in detail:

The treatment group took Celebrex capsules 200mg / time twice a day for 7 days and the control group received routine treatment 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

①痰液、咽拭子、下呼吸道分泌物、血等任何一种标本检测新型冠状病毒核酸阳性,或病毒基因测序与已知的新型冠状病毒高度同源; ②患者有发热或/和肺炎; ③年龄大于等于18岁,男女不限; 

Inclusion criteria

1. The nucleic acid of novel coronavirus 2019 was positive or the virus gene was highly homologous to the known new coronavirus. 2. The patient has fever or / and pneumonia; 3. Aged >=18 years old. 

排除标准:

①有明确塞来昔布过敏史; ②有严重恶心、呕吐或腹泻等临床表现影响药物口服或吸收; ③同时服用可能与塞来昔布存在相互作用的药物; ④合并严重基础疾病,如心脏病(包括心绞痛病史或心肌梗死的冠心病史、房室传导阻滞)、肺脏、肾脏、肝脏等,或有精神疾病不能配合治疗者; ⑤有消化性溃疡病史; ⑥妊娠期、哺乳期妇女; ⑦怀疑或确定目前仍有嗜酒、药物滥用或吸毒病史; ⑧近一个月参加过其他药物试验; 

Exclusion criteria:

1. Have a clear history of celecoxib allergy; 2. Serious nausea, vomiting, diarrhea and other clinical manifestations affect the oral or absorption of the drug; 3. Taking drugs that may interact with celecoxib at the same time; 4. Patients with serious basic diseases, such as heart disease (including history of angina pectoris or coronary heart disease of myocardial infarction, atrioventricular block), lung, kidney, liver, etc., or mental diseases that cannot be treated together; 5. History of peptic ulcer; 6. Pregnant and lactating women; 7. Suspected or confirmed that there is still a history of alcohol, drug abuse or drug abuse; 8. Participated in other drug trials in the past month. 

研究实施时间:

Study execute time:

From2020-02-17To 2020-06-17 

干预措施:

Interventions:

组别:

治疗组

样本量:

30

Group:

Experimental group

Sample size:

干预措施:

塞来昔布口服,每天2次,共7天

干预措施代码:

Intervention:

Celebrex capsules 200mg / time twice a day for 7 days

Intervention code:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

routine treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州市第八人民医院 

单位级别:

三甲医院 

Institution
hospital:

Guangzhou Eighth People's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

前列腺素E2

指标类型:

主要指标 

Outcome:

Prostaglandin E2

Type:

Primary 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:

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:

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):

试验开始前,由统计专家根据统计软件对1~60数字进行随机分配,产生随机分配表,所选择的区组长度和随机种子数等参数一同保存于统计专家处。统计专家事先根据随机分配表,按入选顺序从小到大给予随机编号(1-60),每个随机编号对应一个信封,信封内装着对应的随机号,将信封封好后交给负责筛选入组的研究人员。筛选合格的受试者,按照入组的先后顺序领到信封,拆开信封后取出随机号码交给负责治疗及观察的研究人员,由该研究人员联系统计专家,统计专家根据随机分配表告知该随机号对应的组别,从而将受试者随机分配到试验组或对照组,并进行相应的治疗和访视观察。每位受试者的随机号是唯一的,在整个试验过程中保持不变。

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

Prior to the start of the experiment, a statistical expert randomly assigns 1 to 60 numbers according to the statistical software to generate a random allocation table. The selected block length and random seed number are stored together with the statistical expert.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

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):

发表论文时

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

with publication

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:

病例记录表

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-04-05
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