Post-COVID-19 Outpatient Care and Biomarkers

Recruiting

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Post-COVID-19 without long-COVID syndrome	Laboratory investigations	Patients with previous COVID-19 disease, without long COVID symptoms
Long-COVID	Laboratory investigations	Patients with previous COVID-19 disease, and having long COVID symptoms 3 months after the active infection.
IcMP (positive control)	Laboratory investigations	Patients with ischemic heart disease without COVID-19 disease, and vaccinated at least with one injection
Healthy (negative control)	Laboratory investigations	Healthy individuals without COVID-19 disease, and vaccinated at least with one injection

Primary Outcome Measures

Name	Time	Method
Change in circulating biomarkers	3 years	circularRNA

Secondary Outcome Measures

Name	Time	Method
Change in circulating proteins	3 years	Proteomics
Change in neutralizing antibodies	3 years	neutralizing antibodies
Changes in ECGs	3 years	ECG signs
Cardiac magnetic resonance imaging abnormalities	3 years	Pericardial effusion

Locations (1): Department of Cardiology, Medical University of Vienna
🇦🇹
Vienna, Austria

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