Post-COVID-19 Outpatient Care and Biomarkers (POSTCOV)

Medical University of Vienna

Status: Enrolling

Conditions: Post Viral Fatigue; POTS; Viral Myocarditis

Treatments: Diagnostic Test: Laboratory investigations

Study type: Observational

Funder types: Other

Identifiers

NCT05398952

Protocol Version 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

2,000 participants in 4 patient groups

Long-COVID

Description:

Patients with previous COVID-19 disease, and having long COVID symptoms 3 months after the active infection.

Treatment:

Diagnostic Test: Laboratory investigations

Post-COVID-19 without long-COVID syndrome

Description:

Patients with previous COVID-19 disease, without long COVID symptoms

Treatment:

Diagnostic Test: Laboratory investigations

IcMP (positive control)

Description:

Patients with ischemic heart disease without COVID-19 disease, and vaccinated at least with one injection

Treatment:

Diagnostic Test: Laboratory investigations

Healthy (negative control)

Description:

Healthy individuals without COVID-19 disease, and vaccinated at least with one injection

Treatment:

Diagnostic Test: Laboratory investigations