今天是:2020-05-29 星期五

芦可替尼联合输注间充质干细胞治疗重症新型冠状病毒肺炎(COVID-19)患者的前瞻性、单盲、随机对照临床研究
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注册号:

Registration number:

ChiCTR2000029580 

最近更新日期:

Date of Last Refreshed on:

2020-03-09 

注册时间:

Date of Registration:

2020-02-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

芦可替尼联合输注间充质干细胞治疗重症新型冠状病毒肺炎(COVID-19)患者的前瞻性、单盲、随机对照临床研究 

Public title:

Severe novel coronavirus pneumonia (COVID-19) patients treated with ruxolitinib in combination with mesenchymal stem cells: a prospective, single blind, randomized controlled clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

芦可替尼联合输注间充质干细胞治疗重症新型冠状病毒肺炎(COVID-19)患者的前瞻性、单盲、随机对照临床研究 

Scientific title:

Severe novel coronavirus pneumonia (COVID-19) patients treated with ruxolitinib in combination with mesenchymal stem cells: a prospective, single blind, randomized controlled clinical trial 

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:

曹阳 

研究负责人:

周剑峰 

Applicant:

Cao Yang 

Study leader:

Jianfeng Zhou 

申请注册联系人电话:

Applicant telephone:

+86 027 83665526 

研究负责人电话:

Study leader's telephone:

+86 027 83665506 

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:

caoyangemma@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhougene@medmail.com.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:

武汉市硚口区解放大道1095号 华中科技大学同济医学院附属同济医院  

研究负责人通讯地址:

武汉市硚口区解放大道1095号 华中科技大学同济医学院附属同济医院  

Applicant address:

1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, China 

Study leader's address:

1095 Jiefang Avenue, 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:

华中科技大学同济医学院附属同济医院血液内科  

Applicant's institution:

Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology  

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:

TJ-C20200115 

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:

华中科技大学同济医学院附属同济医院医学伦理委员会  

Name of the ethic committee:

Medical ethics committee of Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-30 

伦理委员会联系人:

杜艾桦 

Contact Name of the ethic committee:

Aihua Du 

伦理委员会联系地址:

武汉市硚口区解放大道1095号 

Contact Address of the ethic committee:

1095 Jiefang Avenue, 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:

华中科技大学同济医学院附属同济医院 

Primary sponsor:

Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology  

研究实施负责(组长)单位地址:

武汉市硚口区解放大道1095号 

Primary sponsor's address:

1095 Jiefang Avenue, Hankou, 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):

Country:

China

Province:

Hubei

City:

单位(医院):

华中科技大学同济医学院附属同济医院

具体地址:

武汉市硚口区解放大道1095号

Institution
hospital:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address:

1095 Jiefang Avenue, Hankou, Wuhan

经费或物资来源:

华中科技大学同济医学院附属同济医院,武汉市科技局,华中科技大学,山东省齐鲁细胞治疗工程技术有限公司,北京诺华制药公司 

Source(s) of funding:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; Wuhan Bureau of Science and Technology; Huazhong University 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:

1. 主要目的: 新型临床治疗方案的安全性和有效性 2. 次要目的: 1)新的治疗方案治疗重症新型冠状病毒肺炎7天、1个月的好转率、2个月的治愈率; 2)对重症新型冠状病毒肺炎患者肺功能及长期致残率的影响、生活质量的影响; 3. 探索性目的:治疗过程中外周血病毒拷贝数的动态变化与临床治疗反应的关系。 

Objectives of Study:

1. Primary purpose: The study is designed to test the safety and efficacy of this this novel treatment strategy. 2. Secondary purpose 1) the study is designed to assess the improvement rates at 7-days and 1-month, the cure rates on 2 months of critical COVID-19 pneumonia with the novel treatment strategy 2) the study is designed to study the impact of pulmonary function, long-term disability rates and quality of life of severe pneumonia patients with COVID-19 infection 3. Investigational purpose: the study is designed to detect the dynamic changes of the virus copies and its correlation with clinical treatment response. 

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、年龄≥ 18 岁≤75 岁; 2、经过临床诊断的新型冠状病毒感染患者;或血清抗体(IgM或IgG)阳性患者;或经过PCR确证的新型冠状病毒感染患者; 3、重型/极重型患者。 

Inclusion criteria

1. Aged >= 18 years and <= 75 years; 2. Patients clinically diagnosed as novel coronavirus infection; or with positive serum antibodies (IgM or IgG); or with novel coronavirus infection confirmed by PCR; 3. Severe/critical patients. 

排除标准:

1. 合并其他恶性肿瘤需要治疗者; 2, 合并其他药物无法控制的严重心脑血管及代谢性疾病; 3. 存在脑功能紊乱的临床症状或严重的精神性疾病不能理解或遵从研究方案; 4. 行气管插管有创通气者; 5. 无法保证完成必须的治疗计划和随访观察的患者; 6. 育龄女性妊娠试验阳性或哺乳期妇女未停止哺乳; 7. 入组时合并其他感染者; 8. 其他使方案不能安全进行的情况。 

Exclusion criteria:

1. Patients with other malignant tumors requiring treatment; 2. Severe cardiovascular and metabolic diseases beyond the control of combination with other drugs 3. Patients with clinical symptoms of brain dysfunction or serious mental illness who cannot understand or follow the study protocol; 4. Endotracheal intubation with invasive ventilation; 5. Patients who cannot guarantee completion of necessary treatment plan and follow-up observation; 6. Women of child-bearing age who are positive in pregnancy test or do not stop breastfeeding in lactation period; 7. Patients with other infections at the time of enrollment; 8. Other circumstances that prevent the protocol from proceeding safely. 

研究实施时间:

Study execute time:

From2020-01-31To 2020-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

35

Group:

Experimental group

Sample size:

干预措施:

芦可替尼联合输注间充质干细胞

干预措施代码:

Intervention:

Ruxolitinib combined with mesenchymal stem cell

Intervention code:

组别:

对照组

样本量:

35

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):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

华中科技大学同济医学院附属同济医院 

单位级别:

三甲 

Institution
hospital:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

安全性

指标类型:

主要指标 

Outcome:

Safety

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:

外周血

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:

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):

随机数字表

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

Random number table

盲法:

单盲

Blinding:

single blind

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/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):

试验完成后12个月内公开,采用临床试验公共管理平台ResMan向公众开放查询

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

The data will be published in the public management platform of clinical trials ResMan after the Study Completed 12 mouths

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:

设计有临床专用CRF表,专人进行纸质记录,并录入数据库,保存于研究者处;患者临床病史记录为纸质版,主管医师签字后保存于长征医院病案室,以备查阅。

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

Each patient are required to fill one CRF table, All the CRF tables saved by researchers and will be saved by data base. The medical records with the signature of the doctor in charge are all in print edition, which will be saved in the medical-record department of Wuhan Tongji hospital.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-05
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