All Eyes on PCS - Analysis of the Retinal Microvasculature in Patients With Post-COVID-19 Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- PCS patients show an impaired retinal vessel responsiveness when compared with fully recovered COVID-19 participants.
研究概览
简要总结
The goal of this observational, prospective study is to in depth analyze the retinal microvasculature in patients with Post-COVID-19 Syndrome (PCS). The main questions it aims to answer is:
Do patients with PCS show a prolonged endothelial dysfunction when compared with fully COVID-19 recovered participants? Does symptom severity in PCS patients correlate with the extend of endothelial dysfunction? Do these changes correlate with improvement in symptoms in the prospective observation?
详细描述
The investigators will recruit patients with PCS, fully COVID-19 recovered participants and COVID-19 infection naïve participants. After comprehensive clarification and given written informed consent, measurements will take place in the Klinikum rechts der Isar. To evaluate the retinal microvasculature dynamic retinal vessel analysis (DVA) and optical coherence tomography (OCT) are used. Patient reported outcomes (PROM) of PCS typical symptoms will be collected using standardized questionnaires. To ensure data quality the investigators will use standard operating procedures (SOP) for both technical measurements and data collection. For DVA measurements all examiners will be trained by a single experienced supervisor and must reach high image accuracy and quality in at least 10 volunteers. Examiners are only involved in data acquisition.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Post-COVID syndrome (positive PCR or positive rapid antibody test ≥3 months) with a currently existing, PCS-typical complaint complex, ongoing for at least 2 months and cannot be explained by an alternative diagnosis.
- •Control group: recovered from COVID-19 infection (positive PCR or positive rapid antibody test ≥ 3 months) without residual symptoms.
- •Healthy cohort: no history of COVID-19 infection
排除标准
- •Missing or incomplete consent form
- •Age < 18 years
- •Pregnancy
- •Malignancy
- •Diseases associated with a significant change in life expectancy
- •Autoimmune diseases of the rheumatological type
结局指标
主要结局
PCS patients show an impaired retinal vessel responsiveness when compared with fully recovered COVID-19 participants.
时间窗: Baseline
Static and dynamic parameters of the retinal vessel analysis.
次要结局
- PCS patients with improved symptoms show a change in retinal vessel responsiveness after 6 months when compared with baseline parameters.(Baseline to month 6)
- PCS patients show a decrease in vessel density in OCT-A when compared with COVID-19 recovered participants.(Baseline)
- Symptom severity of PCS in patients correlates with impaired retinal vessel responsiveness.(Baseline)
- PCS patients show an impaired retinal vessel responsiveness at baseline when compared with infection naïve participants.(Baseline)
- PCS patients with impaired RVA analysis show elevated levels of markers of endothelial dysfunction and of chronic inflammation when compared with COVID-19 recovered cohort.(Baseline)
- PCS patients with impaired RVA show a reactivation of EBV.(Baseline)
- Characterization of immune cell composition in PCS patients and comparison with COVID-19 recovered and COVID-19 infection naïve participants.(Baseline)
研究者
PD Dr. Christoph Schmaderer
Principal Investigator
Technical University of Munich