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A randomized, open-label study to evaluate the efficacy and safety of low-dose corticosteroids in hospitalized patients with novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000029656 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项评价小剂量激素治疗2019新型冠状病毒肺炎(COVID-19)住院患者的疗效和安全性随机、开放、对照的研究 

Public title:

A randomized, open-label study to evaluate the efficacy and safety of low-dose corticosteroids in hospitalized 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:

一项评价小剂量激素治疗2019新型冠状病毒肺炎(COVID-19)住院患者的疗效和安全性随机、开放、对照的研究 

Scientific title:

A randomized, open-label study to evaluate the efficacy and safety of low-dose corticosteroids in hospitalized patients with novel coronavirus pneumonia (COVID-19) 

研究课题代号(代码):

Study subject ID:

CAP-China coronavirus treatment 

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:

李丽 

研究负责人:

杜荣辉 

Applicant:

Li Li 

Study leader:

Ronghui Du 

申请注册联系人电话:

Applicant telephone:

+86 13297001562 

研究负责人电话:

Study leader's telephone:

+86 15337110926 

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:

ly_li@aliyun.com 

研究负责人电子邮件:

Study leader's E-mail:

bluesearh006@sina.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:

湖北省武汉市硚口区宝丰路28号 

研究负责人通讯地址:

湖北省武汉市硚口区宝丰路28号 

Applicant address:

28 Baofeng Road, Qiaokou District, Wuhan, Hubei, China 

Study leader's address:

28 Baofeng Road, Qiaokou District, Wuhan, 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:

武汉市肺科医院 

Applicant's institution:

Wuhan Pulmonary 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:

武肺伦理(2020)年第(1)号 

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:

武汉市肺科医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Wuhan Pulmonary Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-29 

伦理委员会联系人:

段琼红 

Contact Name of the ethic committee:

Qionghong Duan 

伦理委员会联系地址:

湖北省武汉市硚口区宝丰路28号 

Contact Address of the ethic committee:

28 Baofeng Road, Qiaokou District, Wuhan, 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:

武汉市肺科医院 

Primary sponsor:

Wuhan Pulmonary Hosptial 

研究实施负责(组长)单位地址:

湖北省武汉市硚口区宝丰路28号 

Primary sponsor's address:

28 Baofeng Road, Qiaokou District, Wuhan, 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

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉市肺科医院

具体地址:

硚口区宝丰路28号

Institution
hospital:

Wuhan Pulmonary Hosptial

Address:

28 Baofeng Road, Qiaokou District

经费或物资来源:

科技部新型冠状病毒应急专项 

Source(s) of funding:

Emergency Project for 2019-nCoV of Ministry of Science and Technology 

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:

评价小剂量激素治疗新型冠状病毒感染的成人住院患者的疗效和安全性。 

Objectives of Study:

To evaluate the efficacy and safety of low-dose corticosteroids in hospitalized 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. 成人(定义为年龄≥ 18 岁); 2. 经过PCR/血清抗体确证的新型冠状病毒感染患者; 3. 症状发作与随机入组之间的时间间隔在10天以内,症状发作主要以发热作为判定依据,若无发热可使用咳嗽或其他相关症状; 4. 影像学证实的肺炎; 5 .静息未吸氧状态下,患者血氧饱和度SPO2 ≤ 94%或呼吸急促(呼吸频率≥24)或氧合指数≤300 mmHg。 

Inclusion criteria

1. Adults (defined as age >= 18 years); 2. Patients with new type of coronavirus infection confirmed by PCR / serum antibodies; 3. The time interval between symptom onset and random enrollment is within 10 days.The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used; 4. Imaging confirmed pneumonia; 5. In the state of no oxygen at rest, the patient's blood oxygen saturation SPO2 <= 94% or shortness of breath (breathing frequency >= 24) or oxygenation index <= 300mmHg. 

排除标准:

1. 已知口服或静脉接受激素治疗; 2. 入院时由于伴随病需要激素治疗; 3. 糖尿病患者,正在接受口服药物或胰岛素治疗; 4. 已知的地塞米松或其他赋形剂禁忌症(如难治性高血压;癫痫或谵妄状态和青光眼等); 5. 已知的近3个月活动性消化道出血; 6. 已知的难以纠正低钾血症; 7. 已知继发细菌或真菌感染; 8. 已知的免疫抑制状态(如化疗/放疗/术后一月内, HIV感染); 9. 临床医生认为参加试验可能会造成患者损害(如严重淋巴细胞减低); 10. 患者可能在 72h 内转至非参与医院。 

Exclusion criteria:

1. Known to receive hormone therapy orally or intravenously; 2. Hormone therapy is needed due to concomitant disease upon admission; 3. Patients with diabetes are receiving oral medication or insulin therapy; 4. Known contraindications to dexamethasone or other excipients (such as refractory hypertension; epilepsy or delirium and glaucoma); 5. Known active gastrointestinal bleeding in the past 3 months; 6. Known difficulties in correcting hypokalemia; 7. Known secondary bacterial or fungal infections; 8. Known immunosuppressive status (such as chemotherapy / radiotherapy / HIV infection within one month after surgery); 9. The clinician thinks that participating in the trial may cause patient damage (such as severe lymphocyte reduction); 10. The patient may be transferred to a non-participating hospital within 72 hours. 

研究实施时间:

Study execute time:

From2020-02-14To 2020-04-14 

征募观察对象时间:

Recruiting time:

From2020-02-14To 2020-03-14 

干预措施:

Interventions:

组别:

对照组

样本量:

50

Group:

control group

Sample size:

干预措施:

标准治疗

干预措施代码:

Intervention:

Standard treatment

Intervention code:

组别:

试验组

样本量:

50

Group:

experimental group

Sample size:

干预措施:

标准治疗+注射用甲泼尼龙

干预措施代码:

Intervention:

Standard treatment and methylprednisolone for injection

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉市肺科医院 

单位级别:

三级乙等 

Institution
hospital:

Wuhan Pulmonary Hosptial  

Level of the institution:

Tertiary B 

测量指标:

Outcomes:

指标中文名:

心电图

指标类型:

主要指标 

Outcome:

ECG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胸部影像学检查

指标类型:

主要指标 

Outcome:

Chest imaging

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

并发症记录

指标类型:

主要指标 

Outcome:

Complications

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生命体征

指标类型:

主要指标 

Outcome:

vital signs

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NEWS2评分

指标类型:

主要指标 

Outcome:

NEWS2 score

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:

鼻咽拭子

组织:

Sample Name:

Nasopharyngeal 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/气管内吸出物/balf

组织:

Sample Name:

Sputum / tracheal aspirate / balf

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:

粪便/肛拭子

组织:

Sample Name:

Feces / anal swabs

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:

血浆

组织:

Sample Name:

plasma

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 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):

本研究采用电话/微信随机,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1:1,按照氧疗支持水平(是否需要无创通气或更高程度支持)进行分层。具体随机过程为:在确认受试者提供知情同意书后,并符合所有入选标准且不符合任意一条排除标准,对受试者进行随机,获得受试者的随机号及药物分配情况。

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

In this study, telephone / WeChat randomization was used. In order to ensure the concealment of distribution, the personnel responsible for randomization shall not participate in patient disease treatment and prognosis evaluation.The randomization process will allow the ratio of patients in the treatment group and the&

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):

Http://www.chinapneumonia.cn/

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

Http://www.chinapneumonia.cn/

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(Case Record Form, CRF)

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

病例记录表(Case Record Form, CRF)

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-02-09
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