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

NCT05635552 | Unknown

• 1 other identifier: 2022317PCS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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?

Conditions

Long Covid19; Post COVID-19 Condition; Endothelial Dysfunction

Keywords

Retinal Vessel Analysis; Retinal microvasculature; Autoimmunity; Inflammation; Vasculopathy

Outcome Measures

Primary Outcomes (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.

  Baseline

Secondary Outcomes (7)

• PCS patients show an impaired retinal vessel responsiveness at baseline when compared with infection naïve participants.

  Baseline

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

  Baseline to month 6

• Symptom severity of PCS in patients correlates with impaired retinal vessel responsiveness.

  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

Study Arms (3)

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.

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 participants

Participants with Sars-CoV-2 infection at least 3 months ago (positive PCR or positive rapid antibody test) which are fully recovered.

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 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.

Diagnostic Test: Dynamic retinal vessel analysis (DVA); Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Biochemistry and immune phenotyping

Interventions

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.

COVID-19 infection naïve; COVID-19 recovered participants; PCS patients

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.

COVID-19 infection naïve; COVID-19 recovered participants; PCS patients

Biochemistry and immune phenotyping DIAGNOSTIC_TEST

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

COVID-19 infection naïve; COVID-19 recovered participants; PCS patients

Handgrip strength test DIAGNOSTIC_TEST

Measure the maximum isometric strength of the hand and forearm muscles and their fatiguability.

COVID-19 recovered participants; PCS patients

Questionnaires (Patient reported outcomes) DIAGNOSTIC_TEST

The questionnaires evaluate anxiety, depression, chronic fatigue, quality of life, and post-covid typical symptoms

COVID-19 recovered participants; PCS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample, Post-Covid ambulance, general practitioner

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (1)

Klinikum rechts der Isar

München, Bavaria, 81675, Germany

RECRUITING

Related Publications (3)

• 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.

  PMID: 35875815 BACKGROUND

• 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.

  PMID: 38041762 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.

  PMID: 37507580 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and saliva samples are collected from the participants.

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Autoimmune Diseases; Inflammation; Vascular Diseases

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Christoph Schmaderer, Prof. Dr.

  Technical University Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Schmaderer, Prof. Dr.

CONTACT

089 4140 5053; christoph.schmaderer@mri.tum.de

Timon Kuchler

CONTACT

089 4140 8189; timon.kuchler@mri.tum.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 2, 2022
• Study Start: October 17, 2022
• Primary Completion: February 21, 2023
• Study Completion: July 21, 2023
• Last Updated: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)