ChiCTR2100050580招募中Unknown
Early detection and surveillance of COVID-19 infection by non-invasive ophthalmic evaluations
Food and Health Bureau - Health and Medical Research Fund Commissioned Research on the Novel Coronavirus Disease (COVID-19)3 个研究点 分布在 1 个国家目标入组 2,080 人开始时间: 2021年9月1日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 2,080
- 试验地点
- 3
- 主要终点
- Descriptive statistics of the clinical, demographic and ophthalmic data
研究概览
简要总结
- To compare among groups on
- viral load in ocular versus upper respiratory samples;
- recent-onset ocular versus respiratory symptoms
- COVID19-associated ocular changes
- To follow-up on subjects with any positive ocular finding(s) up to 12 months
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Confirmed cases fulfilling laboratory criteria;
- •Probable cases: epidemiological link to a confirmed case/outbreak of COVID-19 and radiological evidence of pneumonia regardless of COVID-19 testing results;
- •Convalescent cases;
- •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
- •Mentally not fit for consent;
- •Patients with recent (< 6 months) pneumonia or COVID19 cannot be recruited as healthy control.
研究组 & 干预措施
Case series
Nil
结局指标
主要结局
Descriptive statistics of the clinical, demographic and ophthalmic data
时间窗: Week 2, Month 4, Month 12
Concordance rate on RT-PCR results between ocular and respiratory samples by Kendall's Coefficient of Concordance
时间窗: Week 2, Month 4, Month 12
次要结局
- Correlation of ophthalmic data with RT-PCR by mixed linear regression model(Week 2, Month 4, Month 12)
- Serial viral load changes in positive ocular samples by serial paired t-test(Week 2, Month 4, Month 12)
- Longitudinal ophthalmic data from patients with positive findings(Week 2, Month 4, Month 12)
研究者
研究点 (3)
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