Today is 2020-07-07

Study for the route of ocular surface transmission of novel coronavirus pneumonia (COVID-19) infection and related eye diseases
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注册号:

Registration number:

ChiCTR2000030489 

最近更新日期:

Date of Last Refreshed on:

2020-03-04 

注册时间:

Date of Registration:

2020-03-04 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

新型冠状病毒感染(COVID-19)的眼表传播途径及相关眼病研究 

Public title:

Study for the route of ocular surface transmission of novel coronavirus pneumonia (COVID-19) infection and related eye diseases 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型冠状病毒感染(COVID-19)的眼表传播途径及相关眼病研究 

Scientific title:

Study for the route of ocular surface transmission of novel coronavirus pneumonia (COVID-19) infection and related eye diseases 

研究课题代号(代码):

Study subject ID:

国家自然科学基金(81974136和81900859) 

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:

陈丽雯 

研究负责人:

孙旭芳 

Applicant:

Liwen Chen 

Study leader:

Xufang Sun 

申请注册联系人电话:

Applicant telephone:

+86 13659802909 

研究负责人电话:

Study leader's telephone:

+86 18627770651 

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:

dollychen1158@foxmail.com 

研究负责人电子邮件:

Study leader's E-mail:

s_1862777@163.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解放大道1095号 

研究负责人通讯地址:

湖北省武汉市硚口区解放大道1095号 

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:

430030 

研究负责人邮政编码:

Study leader's postcode:

430030 

申请人所在单位:

华中科技大学同济医学院附属同济医院眼科 

Applicant's institution:

Department of Ophthalmology, 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-C20200139 

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伦理委员会 

Name of the ethic committee:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Institutional Review Board Approval 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-28 

伦理委员会联系人:

常慕君 

Contact Name of the ethic committee:

Mujun Chang 

伦理委员会联系地址:

湖北省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伦理委员会 

Contact Address of the ethic committee:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Institutional Review Board Approval, 1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 027-83662635 

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:

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

研究实施负责(组长)单位地址:

湖北省武汉市硚口区解放大道1095号 

Primary sponsor's address:

1095 Jiefang Avenue, 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):

华中科技大学同济医学院附属同济医院

具体地址:

湖北省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, Qiaokou District

经费或物资来源:

国家自然科学基金(81974136和81900859) 

Source(s) of funding:

National natural science foundation of China (81974136 and 81900859) 

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:

流行病学研究 

Study type:

Epidemilogical research 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

(1) 通过RT-PCR,数字PCR,NGS等技术寻找新冠病毒眼表感染的确切证据。 (2) 观察新冠肺炎眼部感染患者的症状,体征,疾病的转归,总结新冠肺炎相关眼病的临床特征,丰富新冠病毒感染的临床症候谱。 (3) 了解疫情期间居民眼部防护的认知,结合新冠肺炎眼部症状及临床检测,为人群特别是医务人员的防护提供决策依据。 

Objectives of Study:

(1) Find exact evidence of SARS-CoV-2 ocular transmission via various detection methods like RT-PCR, dPCR and NGS; (2) Summarize the clinical features of SARS-CoV-2 related ocular diseases and enrich COVID-2019 clinical symptom spectrum; (3) Based on the resident congnition on ocular protection, and symptoms and clinical detections of SARS-CoV-2 related ocular diseases, we aim to provide evidence-based clinical decision support.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1. COVID-19疑似或确诊病人:①符合以下疑似或确诊病例诊断标准;②年龄18-70岁。 1.1疑似病例诊断标准: 1.1.1流行病学史: (1)发病前14天内有武汉市及周边地区,或其他有病例报告社区的旅行史或居住史; (2)发病前14天内与新型冠状病毒感染者(核酸检测阳性者)有接触史; (3)发病前14天内曾接触过来自武汉市及周边地区,或来自有病例报告社区的发热或有呼吸道症状的患者; (4)聚集性发病(2周内在小范围如家庭、办公室、学校班级等场所,出现2例及以上发热和/或呼吸道症状的病例)。 1.1.2临床表现: (1)发热和/或呼吸道症状; (2)具有上述新型冠状病毒肺炎影像学特征; (3)发病早期白细胞总数正常或减少,或淋巴细胞计数正常或减少。 1.1.3有流行病学史中的任何一条,且符合临床表现中任意2条。无明确流行病学史的,符合临床表现中的3条。 1.2确诊病例诊断标准: 疑似病例同时具备以下病原学或血清学证据之一者: (1)实时荧光RT-PCR检测 新型冠状病毒高度同源; (2)病毒基因测序,与已知的新型冠状病毒高度同源; (3)血清新型冠状病毒特异性IgM抗体和IgG抗体阳性;血清新型冠状病毒特异性IgG抗体由阴性转为阳性或恢复期较急性期4倍及以上升高。 2. 普通非新冠肺居民: 纳入标准:①武汉居民;②非COVID-2019病人。 3. 医务人员 纳入标准:①年龄18-70岁;②医院在职人员。 

Inclusion criteria

1. COVID-19 suspected or confirmed patients: meet the following suspected or confirmed case diagnostic criteria; aged between 18 and 70 years old; 1.1 Diagnostic criteria for suspected cases; 1.1.1 History of Epidemiology: (1) travel history or residence history within 14 days before the morbidity in Wuhan and its surrounding areas, or in other communities with reported cases; (2) History of contact with new coronavirus infection (positive nucleic acid test) within 14 days before morbidity; (3) Patients with fever or respiratory symptoms from Wuhan and its surrounding areas, or from communities with reported cases, had been contacted within 14 days before the morbidity; (4) Clustered morbidity (2 or more cases of fever and/or respiratory symptoms in a small area such as home, office, school class, etc. Within 2 weeks); 1.1.2 Clinical manifestations: (1) Fever and/or respiratory symptoms; (2) Having the above novel coronavirus pneumonia imaging features; (3) In the early stage of morbidity, the total number of white blood cells is normal or reduced, or the number of lymphocytes is normal or reduced; 1.1.3 Have any of the epidemiological history, and meet any 2 of the clinical signs. If there was no clear epidemiological history, it was in accordance with the 3 items in the clinical signs; 1.2 Diagnostic criteria for confirmed case Suspected cases also have one of the following etiological or serological evidence: (1) Detection of High Homology of Novel Coronavirus by Real-time Fluorescence RT-PCR; (2) Sequencing of the viral genome, which is highly homologous to known novel coronaviruses; (3) Serum specific IgM antibody and IgG antibody of new type coronavirus were positive; the specific IgG antibody of new type coronavirus in serum changed from negative to positive or increased by 4 times or more in recovery stage than in acute stage; 2. non-COVID healthy residents: Wuhan residents; non-COVID-2019 patients; 3. medical staff: age 18-70 years old and in-service hospital staff. 

排除标准:

排除标准: 1. COVID-19疑似或确诊病人: 排除标准:①拒绝配合者;②妊娠期妇女;③精神异常,认知功能障碍患者。 2. 普通非新冠肺居民: 排除标准:①拒绝配合者;②精神异常,认知功能障碍患者。 3. 医务人员 排除标准:①拒绝配合者;②非在职人员;③精神异常,认知功能障碍患者。 

Exclusion criteria:

1. COVID-19 suspected or confirmed patients: (1) Those who refuse to cooperate; (2) Pregnant women; (3)Patients with mental disorders and cognitive dysfunction. 2. non-COVID healthy residents: (1) Those who refuse to cooperate; (2) Patients with mental disorders and cognitive dysfunction. 3. medical staff: (1) Those who refuse to cooperate; (2) non-working staff; (3) Patients with mental disorders and cognitive dysfunction. 

研究实施时间:

Study execute time:

From2020-02-01To 2020-06-30 

干预措施:

Interventions:

组别:

同济医院COVID-2019患者

样本量:

250

Group:

COVID-2019 patients in Tongji Hospital

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

组别:

方舱医院COVID-2019患者

样本量:

250

Group:

COVID-2019 patients in Mobile field hospital

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

组别:

同济医院医务人员

样本量:

250

Group:

Medical staff in Tongji Hospital

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

组别:

武汉居民

样本量:

250

Group:

Control

Sample size:

干预措施:

干预措施代码:

Intervention:

none

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):

华中科技大学同济医学院附属同济医院 

单位级别:

三甲医院 

Institution
hospital:

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

Level of the institution:

Tertiary A Hospital 

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):

光谷科技会展中心方舱医院 

单位级别:

 

Institution
hospital:

Mobile field hospital of China optics valley convention and exhibition center  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

结膜拭子SARS-CoV-2核酸检测

指标类型:

主要指标 

Outcome:

Nuclei acid test of SARS-CoV-2 of conjunctival swab

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咽拭子SARS-CoV-2核酸检测

指标类型:

主要指标 

Outcome:

Nuclei acid test of SARS-CoV-2 of throat swab

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

外周血SARS-CoV-2核酸检测

指标类型:

主要指标 

Outcome:

Nuclei acid test of SARS-CoV-2 of peripheral blood sample

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼部症状

指标类型:

主要指标 

Outcome:

Eye symptoms

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床全身症状

指标类型:

主要指标 

Outcome:

Clinical symptoms

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

既往眼病史

指标类型:

次要指标 

Outcome:

Previous eye diseases

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼药水用药史

指标类型:

次要指标 

Outcome:

Eye drop medication

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

既往全身病史

指标类型:

次要指标 

Outcome:

Previous diseases

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胸部CT

指标类型:

次要指标 

Outcome:

Chest CT

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:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

结膜拭子

组织:

Sample Name:

Conjunctival swabs

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

咽拭子

组织:

Sample Name:

Pharyngeal swabs

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 70 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

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):

实验结束后6个月后公开(2020年 12月31日),将在ResMan平台公开数据

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

Six months after the end of the experiment (Dec.31, 2020), the data will be released on the ResMan platform.

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:

基于问卷调查和同济医院电子病历管理系统,对数据进行采集,数据管理将在ResMan数据库进行数据上传管理。

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

Based on the questionnaire survey and Tongji Hospital electronic medical record management system, data collection, data management will be in the ResMan database for data upload management.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-04
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