Clinical trial NCT05635552: All Eyes on PCS - Analysis of the Retinal Microvasculature in Patients With Post-COVID-19 Syndrome
Official title: All Eyes on PCS - Analysis of the Retinal Microvasculature in Patients With Post-COVID-19 Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Long Covid19
Post COVID-19 Condition
Endothelial Dysfunction
Keywords: Retinal Vessel Analysis
Retinal microvasculature
Autoimmunity
Inflammation
Vasculopathy
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2022-12-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample, Post-Covid ambulance, general practitioner

Brief summary: 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?

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Cataract
* Epilepsy
* Glaucoma

Primary outcomes:
measure: PCS patients show an impaired retinal vessel responsiveness when compared with fully recovered COVID-19 participants.
timeFrame: Baseline
Secondary outcomes:
measure: PCS patients show an impaired retinal vessel responsiveness at baseline when compared with infection naïve participants.
timeFrame: Baseline
measure: PCS patients with improved symptoms show a change in retinal vessel responsiveness after 6 months when compared with baseline parameters.
timeFrame: Baseline to month 6
measure: Symptom severity of PCS in patients correlates with impaired retinal vessel responsiveness.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
measure: PCS patients with impaired RVA show a reactivation of EBV.
timeFrame: Baseline
measure: Characterization of immune cell composition in PCS patients and comparison with COVID-19 recovered and COVID-19 infection naïve participants.
timeFrame: Baseline
measure: PCS patients show a decrease in vessel density in OCT-A when compared with COVID-19 recovered participants.
timeFrame: Baseline
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum rechts der Isar
state: Bavaria
Study officials:
affiliation: Technical University Munich
name: Christoph Schmaderer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bahmer T, Borzikowsky C, Lieb W, Horn A, Krist L, Fricke J, Scheibenbogen C, Rabe KF, Maetzler W, Maetzler C, Laudien M, Frank D, Ballhausen S, Hermes A, Miljukov O, Haeusler KG, Mokhtari NEE, Witzenrath M, Vehreschild JJ, Krefting D, Pape D, Montellano FA, Kohls M, Morbach C, Stork S, Reese JP, Keil T, Heuschmann P, Krawczak M, Schreiber S; NAPKON study group. Severity, predictors and clinical correlates of Post-COVID syndrome (PCS) in Germany: A prospective, multi-centre, population-based cohort study. EClinicalMedicine. 2022 Jul 18;51:101549. doi: 10.1016/j.eclinm.2022.101549. eCollection 2022 Sep.