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| Name | Class |
|---|---|
| Ludwig-Maximilians - University of Munich | OTHER |
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCS patients | Patients with a COVID-19 infection at least 3 months ago (positive PCR or rapid antibody test) and PCS typical symptoms (e.g. fatigue, breast pain, heart palpitations, cognitive impairment) ongoing for at least 2 months and which cannot be explained by an alternative diagnosis. |
| |
| COVID-19 recovered participants | Participants with Sars-CoV-2 infection at least 3 months ago (positive PCR or positive rapid antibody test) which are fully recovered. |
| |
| COVID-19 infection naïve | No history of COVID-19 infection (exclusion via measurement of specific antibodies). Consists of an already established, pre-pandemic healthy cohort and a cohort recruited during the pandemic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic retinal vessel analysis (DVA) | Diagnostic Test | DVA is an established, non-invasive tool to measure the responsiveness of retinal vessels to flickering light. In addition static retinal vessel parameters are recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| PCS patients show an impaired retinal vessel responsiveness when compared with fully recovered COVID-19 participants. | Static and dynamic parameters of the retinal vessel analysis. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| PCS patients show an impaired retinal vessel responsiveness at baseline when compared with infection naïve participants. | Static and dynamic parameters of the retinal vessel analysis. | Baseline |
| PCS patients with improved symptoms show a change in retinal vessel responsiveness after 6 months when compared with baseline parameters. |
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Inclusion Criteria:
Exclusion Criteria:
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Community sample, Post-Covid ambulance, general practitioner
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christoph Schmaderer, Prof. Dr. | Contact | 089 4140 5053 | christoph.schmaderer@mri.tum.de | |
| Timon Kuchler | Contact | 089 4140 8189 | timon.kuchler@mri.tum.de |
| Name | Affiliation | Role |
|---|---|---|
| Christoph Schmaderer, Prof. Dr. | Technical University Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum rechts der Isar | Recruiting | München | Bavaria | 81675 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35875815 | Background | 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. | |
| 42415070 |
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Blood and saliva samples are collected from the participants.
| Optical coherence tomography (OCT) | Diagnostic Test | OCT is an imaging technique which applies low-coherence light to capture high resolution images from the ocular fundus. |
|
| Biochemistry and immune phenotyping | Diagnostic Test | Blood sample collection for clinical chemistry and isolation of PBMCs for FACS analysis. |
|
| Handgrip strength test | Diagnostic Test | Measure the maximum isometric strength of the hand and forearm muscles and their fatiguability. |
|
| Questionnaires (Patient reported outcomes) | Diagnostic Test | The questionnaires evaluate anxiety, depression, chronic fatigue, quality of life, and post-covid typical symptoms |
|
Static and dynamic parameters of the retinal vessel analysis. Test items of the The COVID-19 Yorkshire Rehabilitation Scale (C19-YRS) and PCS questionnaire. Calculation of PCS severity scores (Bahmer, 2022) in each patient with a range of score values from zero (better outcome) to 59 (worse outcome). Comparison of retinal vessel parameters and PCS scores between Baseline and month 6. |
| Baseline to month 6 |
| Symptom severity of PCS in patients correlates with impaired retinal vessel responsiveness. | Correlation between PCS severity scores with static and dynamic parameters of the retinal vessel analysis. | 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. | Measurement of markers of endothelial dysfunction: Concentration of: sICAM, sVCAM, Thrombomodulin, P-Selectin,E-Selectin, ADMA, SADMA, Endothelin-1, ACE-1, ACE-2, ANG-2, GDF-15. Measurement of markers of chronic inflammation Concentration of IFN-β, IFN-λ1,TNFa. Comparison of marker levels to the COVID-19 recovered cohort. | Baseline |
| PCS patients with impaired RVA show a reactivation of EBV. | Using PCR to measure EBV reactivation in patients plasma . | Baseline |
| Characterization of immune cell composition in PCS patients and comparison with COVID-19 recovered and COVID-19 infection naïve participants. | Using flow cytometry to detect different T-cell and monocyte subpopulations. | Baseline |
| PCS patients show a decrease in vessel density in OCT-A when compared with COVID-19 recovered participants. | Parameters of OCT-A. | Baseline |
| Derived |
| Wunderle M, Ribeiro A, Lethen I, Schmaderer C, Wallraven T. Persistent impairments in muscle function and symptom burden in post-COVID syndrome: a prospective longitudinal study. J Transl Med. 2026 Jul 7;24(1):871. doi: 10.1186/s12967-026-08579-z. |
| 38041762 | Derived | Kuchler T, Hausinger R, Braunisch MC, Gunthner R, Wicklein R, Knier B, Bleidissel N, Maier M, Ribero A, Lech M, Adorjan K, Stubbe H, Kotliar K, Heemann U, Schmaderer C. All eyes on PCS: analysis of the retinal microvasculature in patients with post-COVID syndrome-study protocol of a 1 year prospective case-control study. Eur Arch Psychiatry Clin Neurosci. 2024 Dec;274(8):1847-1856. doi: 10.1007/s00406-023-01724-5. Epub 2023 Dec 2. |
| 37507580 | Derived | Kuchler T, Gunthner R, Ribeiro A, Hausinger R, Streese L, Wohnl A, Kesseler V, Negele J, Assali T, Carbajo-Lozoya J, Lech M, Schneider H, Adorjan K, Stubbe HC, Hanssen H, Kotliar K, Haller B, Heemann U, Schmaderer C. Persistent endothelial dysfunction in post-COVID-19 syndrome and its associations with symptom severity and chronic inflammation. Angiogenesis. 2023 Nov;26(4):547-563. doi: 10.1007/s10456-023-09885-6. Epub 2023 Jul 28. |
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D001327 | Autoimmune Diseases |
| D007249 | Inflammation |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007154 | Immune System Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
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