Post-COVID-19 Outpatient Care and Biomarkers

NCT05398952 | Unknown

• 1 other identifier: Protocol Version 2
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Viral Fatigue; Viral Myocarditis; POTS

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in circulating biomarkers

  circularRNA

  3 years

Secondary Outcomes (4)

• Change in circulating proteins

  3 years

• Change in neutralizing antibodies

  3 years

• Changes in ECGs

  3 years

• Cardiac magnetic resonance imaging abnormalities

  3 years

Study Arms (4)

Long-COVID

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

Diagnostic Test: Laboratory investigations

Post-COVID-19 without long-COVID syndrome

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

Diagnostic Test: Laboratory investigations

IcMP (positive control)

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

Diagnostic Test: Laboratory investigations

Healthy (negative control)

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

Diagnostic Test: Laboratory investigations

Interventions

Laboratory investigations DIAGNOSTIC_TEST

Laboratory investigations correlated with symptoms and imaging results

Healthy (negative control); IcMP (positive control); Long-COVID; Post-COVID-19 without long-COVID syndrome

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• Signed informed consent

You may not qualify if:

• non-willingness to participate or withdrawal of informed consent
• Clinically confirmed HFrEF (EF \<40%)
• participation in any SARS-CoV-2 medical treatment trial
• pregnancy

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Cardiology, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (2)

• Gyongyosi M, Hasimbegovic E, Han E, Zlabinger K, Spannbauer A, Riesenhuber M, Hamzaraj K, Bergler-Klein J, Hengstenberg C, Kammerlander A, Kastl S, Loewe C, Beitzke D. Improvement of Symptoms and Cardiac Magnetic Resonance Abnormalities in Patients with Post-Acute Sequelae of SARS-CoV-2 Cardiovascular Syndrome (PASC-CVS) after Guideline-Oriented Therapy. Biomedicines. 2023 Dec 14;11(12):3312. doi: 10.3390/biomedicines11123312.

  PMID: 38137533 DERIVED

• Gyongyosi M, Lukovic D, Mester-Tonczar J, Zlabinger K, Einzinger P, Spannbauer A, Schweiger V, Schefberger K, Samaha E, Bergler-Klein J, Riesenhuber M, Nitsche C, Hengstenberg C, Mucher P, Haslacher H, Breuer M, Strassl R, Puchhammer-Stockl E, Loewe C, Beitzke D, Hasimbegovic E, Zelniker TA. Effect of monovalent COVID-19 vaccines on viral interference between SARS-CoV-2 and several DNA viruses in patients with long-COVID syndrome. NPJ Vaccines. 2023 Sep 29;8(1):145. doi: 10.1038/s41541-023-00739-2.

  PMID: 37773184 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Frozen serum and plasma samples, as well as blood samples stored in RNA and cDNA tubes; peripheral blood mononuclear cells will be separated by Ficoll and frozen.

Study Officials

• Mariann Gyöngyösi, MD PhD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariann Gyöngyösi, MD PhD

CONTACT

+4314040046140; mariann.gyongyosi@meduniwien.ac.at

Christian Hengstenberg, MD PhD

CONTACT

+4314040046140; christian.hengstenberg@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 1, 2022
• Study Start: April 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After the study closure, and publication of the data
• Access Criteria: Upon reasonable request; after signature of the Data Sharing Agreement

Locations

AU (1)