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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Viral Myocarditis; POTS; Post Viral Fatigue
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Mariann Gyöngyösi, MD PhD; Phone Number: +4314040046140; Email: mariann.gyongyosi@meduniwien.ac.at
• Study Contact Backup: Name: Christian Hengstenberg, MD PhD; Phone Number: +4314040046140; Email: christian.hengstenberg@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Department of Cardiology, Medical University of Vienna
    • Contact: Mariann Gyongyosi, MD; Phone Number: +43-1-40400-46140; Email: mariann.gyongyosi@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Outpatient clinical patients with at least 6 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 study. A written informed consent will be present before inclusion. 100 vaccinated HFrEF patient volunteers will be recruited during routine visits to our outpatient clinic. 100 healthy, vaccinated volunteers will be recruited from among hospital staff.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: biomarkers; long/post-COVID; multiorgan disease; cardiovascular imaging
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Cardiomyopathies; Encephalomyelitis; Myocarditis; Fatigue Syndrome, Chronic
• Other Study ID Numbers: Protocol Version 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: upon reasonable request; after signature of the Data Sharing Agreement
• IPD Sharing Time Frame: After the study closure, and publication of the data
• IPD Sharing Access Criteria: Upon reasonable request; after signature of the Data Sharing Agreement
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No