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

Technical University of Munich

Status: Enrolling

Conditions: Long Covid19; Post COVID-19 Condition; Endothelial Dysfunction

Treatments: Diagnostic Test: Questionnaires (Patient reported outcomes); Diagnostic Test: Biochemistry and immune phenotyping; Diagnostic Test: Handgrip strength test; Diagnostic Test: Dynamic retinal vessel analysis (DVA); Diagnostic Test: Optical coherence tomography (OCT)

Study type: Observational

Funder types: Other

Identifiers

NCT05635552

2022317PCS

Details and patient eligibility

About

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?

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 3 patient groups

PCS patients

Description:

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.

Treatment:

Diagnostic Test: Handgrip strength test

Diagnostic Test: Optical coherence tomography (OCT)

Diagnostic Test: Dynamic retinal vessel analysis (DVA)

Diagnostic Test: Questionnaires (Patient reported outcomes)

Diagnostic Test: Biochemistry and immune phenotyping

COVID-19 recovered participants

Description:

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

Treatment:

Diagnostic Test: Handgrip strength test

Diagnostic Test: Optical coherence tomography (OCT)

Diagnostic Test: Dynamic retinal vessel analysis (DVA)

Diagnostic Test: Questionnaires (Patient reported outcomes)

Diagnostic Test: Biochemistry and immune phenotyping

COVID-19 infection naïve

Description:

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.

Treatment:

Diagnostic Test: Optical coherence tomography (OCT)

Diagnostic Test: Dynamic retinal vessel analysis (DVA)

Diagnostic Test: Biochemistry and immune phenotyping