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Post-COVID-19 Outpatient Care and Biomarkers

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05398952
Acronym
POSTCOV
Enrollment
2000
Registered
2022-06-01
Start date
2021-04-01
Completion date
2025-12-31
Last updated
2022-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Viral Fatigue, POTS, Viral Myocarditis

Keywords

long/post-COVID, multiorgan disease, biomarkers, cardiovascular imaging

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.

Interventions

Laboratory investigations correlated with symptoms and imaging results

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in circulating biomarkers3 yearscircularRNA

Secondary

MeasureTime frameDescription
Change in circulating proteins3 yearsProteomics
Change in neutralizing antibodies3 yearsneutralizing antibodies
Changes in ECGs3 yearsECG signs
Cardiac magnetic resonance imaging abnormalities3 yearsPericardial effusion

Countries

Austria

Contacts

Primary ContactMariann Gyöngyösi, MD PhD
mariann.gyongyosi@meduniwien.ac.at+4314040046140
Backup ContactChristian Hengstenberg, MD PhD
christian.hengstenberg@meduniwien.ac.at+4314040046140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026