POSTCOV: Post-COVID-19 Outpatient Care and Biomarkers

Sponsor

Medical University of Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT05398952

Collaborator

(none)

2,000

Enrollment

Location

Anticipated Duration (Months)

35.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Viral Fatigue Viral Myocarditis POTS	Diagnostic Test: Laboratory investigations

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Change in circulating biomarkers [3 years]
circularRNA

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiology, Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator: Mariann Gyöngyösi, MD PhD, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mariann Gyongyosi, Principal Investigator, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT05398952

Other Study ID Numbers:

Protocol Version 2

First Posted:

Jun 1, 2022

Last Update Posted:

Jun 8, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mariann Gyongyosi, Principal Investigator, Medical University of Vienna

long/post-COVID

multiorgan disease

biomarkers

cardiovascular imaging

Additional relevant MeSH terms:

Fatigue Syndrome, Chronic

Myocarditis

Study Results

No Results Posted as of Jun 8, 2022