ChiCTR2100050580 版本V1.1 版本创建时间2022/05/01 15:10:45 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2100050580 

最近更新日期：

Date of Last Refreshed on：

2022-05-01 15:09:41 

注册时间：

Date of Registration：

2021-08-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Early detection and surveillance of COVID-19 infection by non-invasive ophthalmic evaluations

Public title：

Early detection and surveillance of COVID-19 infection by non-invasive ophthalmic evaluations

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Early detection and surveillance of COVID-19 infection by non-invasive ophthalmic evaluations

Scientific title：

Early detection and surveillance of COVID-19 infection by non-invasive ophthalmic evaluations

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：

Jennifer Tsoi 

研究负责人：

Dr Chong Kam Lung Kelvin 

Applicant：

Jennifer Tsoi 

Study leader：

Dr Chong Kam Lung Kelvin 

申请注册联系人电话：

Applicant telephone：

+852 39435818

研究负责人电话：

Study leader's telephone：

+852 39435805

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：

jennifertsoi@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

chongkamlung@cuhk.edu.hk

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：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

研究负责人通讯地址：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

Applicant address：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

Study leader's address：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

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：

香港中文大學眼科與視覺科學系

Applicant's institution：

Department of Ophthalmology and Visual Sciences, CUHK

研究负责人所在单位：

香港中文大學眼科與視覺科學系

Affiliation of the Leader：

Department of Ophthalmology and Visual Sciences, CUHK

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2020.349

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2020-07-22 00:00:00

伦理委员会联系人：

Ms Envy Lee

Contact Name of the ethic committee：

Ms Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

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：

Food and Health Bureau - Health and Medical Research Fund

Primary sponsor：

Food and Health Bureau - Health and Medical Research Fund

研究实施负责（组长）单位地址：

9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, Hong Kong

Primary sponsor's address：

9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

香港中文大學眼科與視覺科學系

具体地址：

九龍亞皆老街147K號香港眼科醫院4樓

Institution
hospital：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

Address：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

经费或物资来源：

Food and Health Bureau - Health and Medical Research Fund Commissioned Research on the Novel Coronavirus Disease (COVID-19)

Source(s) of funding：

Food and Health Bureau - Health and Medical Research Fund Commissioned Research on the Novel Coronavirus Disease (COVID-19)

Target disease：

Novel Coronavirus Pneumonia (COVID-19)

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

1. To compare among groups on - viral load in ocular versus upper respiratory samples; - recent-onset ocular versus respiratory symptoms - COVID19-associated ocular changes 2. To follow-up on subjects with any positive ocular finding(s) up to 12 months  

Objectives of Study：

1. To compare among groups on - viral load in ocular versus upper respiratory samples; - recent-onset ocular versus respiratory symptoms - COVID19-associated ocular changes 2. To follow-up on subjects with any positive ocular finding(s) up to 12 months

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. Confirmed cases fulfilling laboratory criteria;
2. Probable cases: epidemiological link to a confirmed case/outbreak of COVID-19 and radiological evidence of pneumonia regardless of COVID-19 testing results;
3. Convalescent cases;
4. Subjects with epidemiological link to COVID-19, who meet the CHP reporting criteria of COVID-19, inbound travellers under compulsory quarantine at designated places.

Inclusion criteria

1. Confirmed cases fulfilling laboratory criteria;
2. Probable cases: epidemiological link to a confirmed case/outbreak of COVID-19 and radiological evidence of pneumonia regardless of COVID-19 testing results;
3. Convalescent cases;
4. Subjects with epidemiological link to COVID-19, who meet the CHP reporting criteria of COVID-19, inbound travellers under compulsory quarantine at designated places.

排除标准：

1. Mentally not fit for consent;
2. Patients with recent (< 6 months) pneumonia or COVID19 cannot be recruited as healthy control.

Exclusion criteria：

1. Mentally not fit for consent;
2. Patients with recent (< 6 months) pneumonia or COVID19 cannot be recruited as healthy control.

研究实施时间：

Study execute time：

从 From 2021-09-01 00:00:00至 To 2023-08-09 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-09-01 00:00:00 至 To 2022-08-09 00:00:00  

干预措施：

Interventions：

组别：

Case series

样本量：

2780

Group：

Case series

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

Nil

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China 

Province：

Hong Kong SAR 

City：

 

单位(医院)：

威爾士親王醫院 

单位级别：

三级医院 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Tertiary

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China 

Province：

Hong Kong SAR 

City：

 

单位(医院)：

雅麗氏何妙齡那打素醫院 

单位级别：

三级医院 

Institution
hospital：

Alice Ho Miu Ling Nethersole Hospital

Level of the institution：

Tertiary

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China 

Province：

Hong Kong SAR 

City：

 

单位(医院)：

香港中文大學眼科中心 

单位级别：

N/A 

Institution
hospital：

CUHK Eye Centre

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

臨床、人口統計和眼科資料的描述性統計

指标类型：

主要指标

Outcome：

Descriptive statistics of the clinical, demographic and ophthalmic data

Type：

Primary indicator

测量时间点：

Week 2, Month 4, Month 12

测量方法：

Ophthalmic investigations

Measure time point of outcome：

Week 2, Month 4, Month 12

Measure method：

Ophthalmic investigations

指标中文名：

根據 Kendall 一致性係數得出眼部和呼吸道樣本 RT-PCR 結果的一致性

指标类型：

主要指标

Outcome：

Concordance rate on RT-PCR results between ocular and respiratory samples by Kendall's Coefficient of Concordance

Type：

Primary indicator

测量时间点：

Week 2, Month 4, Month 12

测量方法：

Conjunctival swabs

Measure time point of outcome：

Week 2, Month 4, Month 12

Measure method：

Conjunctival swabs

指标中文名：

透過混合線性迴歸模型將眼科數據與 RT-PCR 相關聯

指标类型：

次要指标

Outcome：

Correlation of ophthalmic data with RT-PCR by mixed linear regression model

Type：

Secondary indicator

测量时间点：

Week 2, Month 4, Month 12

测量方法：

Conjunctival swabs

Measure time point of outcome：

Week 2, Month 4, Month 12

Measure method：

Conjunctival swabs

指标中文名：

以連續配對 t 檢定觀察陽性眼部樣本中的連續病毒量變化

指标类型：

次要指标

Outcome：

Serial viral load changes in positive ocular samples by serial paired t-test

Type：

Secondary indicator

测量时间点：

Week 2, Month 4, Month 12

测量方法：

Conjunctival swabs

Measure time point of outcome：

Week 2, Month 4, Month 12

Measure method：

Conjunctival swabs

指标中文名：

來自陽性結果患者的縱向眼科數據

指标类型：

次要指标

Outcome：

Longitudinal ophthalmic data from patients with positive findings

Type：

Secondary indicator

测量时间点：

Week 2, Month 4, Month 12

测量方法：

Ophthalmic investigations

Measure time point of outcome：

Week 2, Month 4, Month 12

Measure method：

Ophthalmic investigations

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

結膜拭子

组织：

Conjunctiva (lower eyelid)

Sample Name：

Conjunctival swabs

Tissue：

Conjunctiva (lower eyelid)

人体标本去向

 使用后保存  

说明

5 years

Fate of sample：

Preservation after use  

Note：

5 years

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 岁 years
最大 Max age 岁 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

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

N/A

Blinding：

N/A

是否共享原始数据：

IPD sharing

No

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）：

N/A

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

N/A

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：

Patient data would be handled with utmost care taking care not to breach patient's privacy in any form. The data would be stored in secure cabinets and/or computers which would be password operated. To protect patient privacy, all research data would be handled in line with HA / Hospital’s policy in handling / storage / destruction of patients’ medical records. Electronic data would be saved in secured computer of the hospital with restricted access. USB Device would not be used for patient information nor personal data. Personal data (name, HKID, OPD / hospital numbers, address and any other personal identifiable information) would not be recorded on the project’s data sheets or electronic files. A study code would be used instead. The document of electronic file containing the linkage information between the study code and the identity of the patient would not contain any other information and would be kept separate from the study data files or data sheets with the same stringent security as the medical record. Any documents or electronic files containing personal identifiable information would be considered as part of the medical record and would be dealt with the same stringent regulations of security according to the hospital policies. All the investigators would be responsible for data handling and protection.

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

Patient data would be handled with utmost care taking care not to breach patient's privacy in any form. The data would be stored in secure cabinets and/or computers which would be password operated. To protect patient privacy, all research data would be handled in line with HA / Hospital’s policy in handling / storage / destruction of patients’ medical records. Electronic data would be saved in secured computer of the hospital with restricted access. USB Device would not be used for patient information nor personal data. Personal data (name, HKID, OPD / hospital numbers, address and any other personal identifiable information) would not be recorded on the project’s data sheets or electronic files. A study code would be used instead. The document of electronic file containing the linkage information between the study code and the identity of the patient would not contain any other information and would be kept separate from the study data files or data sheets with the same stringent security as the medical record. Any documents or electronic files containing personal identifiable information would be considered as part of the medical record and would be dealt with the same stringent regulations of security according to the hospital policies. All the investigators would be responsible for data handling and protection.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-08-29 20:29:00