Post-COVID-19 Outpatient Care and Biomarkers

Study Overview
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Brief Summary
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The aims of this case-control, non-randomized study including patients with post-COVID-19 persisting symptoms are 1) to establish the large blood biobank, 2) to examine levels of circulating inflammatory biomarkers and different classes of non-coding RNAs (ncRNA), such as selected circRNAs and miRNAs, in plasma and serum samples collected from patients with post- COVID-19, 3) to test the levels of cfDNA in plasma and serum, 4) to define correlation between ncRNAs and cf-DNA with persistent clinical symptoms, and type of symptoms, and 5) to investigate diagnostic and prognostic performances of these circulating biomarkers. Study design. This is a prospective registry including biobank.

Detailed Description
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Currently, several studies are ongoing to investigate different treatment modalities of post-COVID-19 symptoms, but there is a complete lack of investigations on biomarkers predicting type, duration or severity of post-COVID-19 symptoms. The aim of this study is to investigate circulatory biomarkers diagnostic or predictive for long/post-COVID-19 syndrome. Study patients. Patients with at least 3 weeks after proven infection by SARS-CoV-2, reflected by at least one positive PCR-test in nose throat swabs, who visits at the Post-COVID-19 outpatient clinic of the Medical University of Vienna, will be consequently recruited into the presented registry. Additionally, 100 vaccinated patients with HFrEF and 100 healthy vaccinated volunteers will be recruited to serve as comparison groups. Methods. Identity of the registry patients will be protected by pseudonymization. During the ambulatory visit, basic clinical examination, electrocardiogram, chest X-ray, routine laboratory tests will be performed. Additionally, venous blood will be collected for biobank. Expected Outcome This registry will provide further insights regarding pathophysiology, risk stratification and treatment of complex post-COVID-19 symptoms. Specific therapies and search of prognostic factors will enable to select patients with high risk of persistence or worsening of their symptoms thereby improve patient care.

Official Title
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Post-COVID-19 Outpatient Care and Biomarkers for Persisting Symptoms of Post-COVID-19 Disease - A Prospective Registry and Biobank

Conditions
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Post Viral Fatigue, Viral Myocarditis, POTS

Intervention / Treatment
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* Diagnostic Test: Laboratory investigations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For post-COVID patient group: Age≥18to90years Proven infection by SARS-CoV2, at least 3 weeks after recovery from the infection Signed informed consent For HFrEF patient group: For vaccinated healthy volunteer control group: Full vaccination against SARS-CoV2 at least 3 weeks before inclusion in the study Signed informed consent Exclusion Criteria: non-willingness to participate or withdrawal of informed consent Clinically confirmed HFrEF (EF <40%) participation in any SARS-CoV-2 medical treatment trial pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Long-COVID<br>Patients with previous COVID-19 disease, and having long COVID symptoms 3 months after the active infection. | Diagnostic Test: Laboratory investigations<br>* Laboratory investigations correlated with symptoms and imaging results<br>|
| Post-COVID-19 without long-COVID syndrome<br>Patients with previous COVID-19 disease, without long COVID symptoms | Diagnostic Test: Laboratory investigations<br>* Laboratory investigations correlated with symptoms and imaging results<br>|
| IcMP (positive control)<br>Patients with ischemic heart disease without COVID-19 disease, and vaccinated at least with one injection | Diagnostic Test: Laboratory investigations<br>* Laboratory investigations correlated with symptoms and imaging results<br>|
| Healthy (negative control)<br>Healthy individuals without COVID-19 disease, and vaccinated at least with one injection | Diagnostic Test: Laboratory investigations<br>* Laboratory investigations correlated with symptoms and imaging results<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in circulating biomarkers | circularRNA | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in circulating proteins | Proteomics | 3 years | 
| Change in neutralizing antibodies | neutralizing antibodies | 3 years | 
| Changes in ECGs | ECG signs | 3 years | 
| Cardiac magnetic resonance imaging abnormalities | Pericardial effusion | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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long/post-COVID, multiorgan disease, biomarkers, cardiovascular imaging