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Long Covid19NCT05635552

All Eyes on PCS - Analysis of the Retinal Microvasculature in Patients With Post-COVID-19 Syndrome

An observational study of Long Covid19 and Post COVID-19 Condition, run by Technical University of Munich at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Dynamic retinal vessel analysis (DVA), Optical coherence tomography (OCT) and Biochemistry and immune phenotyping
How many people
300 participants
Where
1 siteGermany
Study dates
17 Oct 2022to 21 Jul 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Community sample, Post-Covid ambulance, general practitioner

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Cataract
  • Epilepsy
  • Glaucoma

Trial locations and contacts

1 site in 1 country.

Christoph Schmaderer, Prof. Dr. contact

089 4140 5053

christoph.schmaderer@mri.tum.de

Germany1 site, 1 recruiting
  • Klinikum rechts der Isar

    München, Bavaria, 81675

    Christoph Schmaderer, Prof. Dr, 089 4140 5053, christoph.schmaderer@mri.tum.de

    Timon Kuchler, 089 4140 8189, timon.kuchler@mri.tum.de

    Recruiting

Other trials in Germany

About this study

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?

Read the 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.

Being tested
Dynamic retinal vessel analysis (DVA), Optical coherence tomography (OCT), Biochemistry and immune phenotyping, Handgrip strength test, Questionnaires (Patient reported outcomes)
Keywords
Retinal Vessel Analysis, Retinal microvasculature, Autoimmunity, Inflammation, Vasculopathy
Medical subject headings
Post-Acute COVID-19 Syndrome, Autoimmune Diseases, Inflammation, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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 phenotypingDiagnostic test

    Blood sample collection for clinical chemistry and isolation of PBMCs for FACS analysis.

  • Handgrip strength testDiagnostic 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

Study groups in NCT05635552
Study groupRoleWhat they receive
PCS patientsPatients 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.
Receives: Diagnostic Test: Dynamic retinal vessel analysis (DVA); Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Biochemistry and immune phenotyping; Diagnostic Test: Handgrip strength test; Diagnostic Test: Questionnaires (Patient reported outcomes)
COVID-19 recovered participantsParticipants with Sars-CoV-2 infection at least 3 months ago (positive PCR or positive rapid antibody test) which are fully recovered.
Receives: Diagnostic Test: Dynamic retinal vessel analysis (DVA); Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Biochemistry and immune phenotyping; Diagnostic Test: Handgrip strength test; Diagnostic Test: Questionnaires (Patient reported outcomes)
COVID-19 infection naïveNo 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.
Receives: Diagnostic Test: Dynamic retinal vessel analysis (DVA); Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Biochemistry and immune phenotyping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

Secondary outcomes (7)
  1. 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.

    Measured: Baseline

  2. PCS patients with improved symptoms show a change in retinal vessel responsiveness after 6 months when compared with baseline parameters.

    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.

    Measured: Baseline to month 6

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Baseline

  5. PCS patients with impaired RVA show a reactivation of EBV.

    Using PCR to measure EBV reactivation in patients plasma .

    Measured: Baseline

  6. 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.

    Measured: Baseline

  7. PCS patients show a decrease in vessel density in OCT-A when compared with COVID-19 recovered participants.

    Parameters of OCT-A.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2022
  2. Study start17 Oct 2022
  3. Primary completion21 Feb 2023 (estimated)
  4. Study completion21 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05635552
Sponsor's protocol ID
2022317PCS
Status last verified
Nov 2022
First submitted
18 Nov 2022
Last updated
2 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35875815
  • Wallraven T, Gunthner R, Lethen I, Ribeiro A, Lech M, Oertel FC, Reess LG, Haller B, Streese L, Hanssen H, Basta-Wunderle M, Schmaderer C. Microvascular remodeling and endothelial dysfunction across the post-COVID-19 spectrum: a prospective observational case-control study. BMC Med. 2026 Aug 19;24(1):456. doi: 10.1186/s12916-026-05144-9.

    PubMed 42625188
  • 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.

    PubMed 42415070
  • 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.

    PubMed 38041762
  • 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.

    PubMed 37507580

Questions about this trial

What is this clinical trial studying?

An observational study of Long Covid19 and Post COVID-19 Condition, run by Technical University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Christoph Schmaderer, Prof. Dr. (089 4140 5053, christoph.schmaderer@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PCS patients show an impaired retinal vessel responsiveness when compared with fully recovered COVID-19 participants. (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05635552, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.

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