Post Viral FatiguePOSTCOVNCT05398952
Post-COVID-19 Outpatient Care and Biomarkers
An observational study of Post Viral Fatigue and Viral Myocarditis, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Viral Fatigue, Viral Myocarditis, POTS
- What is being tested?
- Laboratory investigations
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 2,000 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2021to 31 Dec 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Cardiology, Medical University of Vienna
Vienna, 1090
Mariann Gyongyosi, MD, +43-1-40400-46140, mariann.gyongyosi@meduniwien.ac.at
About this study
Official title: 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.
Read the 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.
- Conditions
- Post Viral Fatigue, Viral Myocarditis, POTS
- Being tested
- Laboratory investigations
- Keywords
- long/post-COVID, multiorgan disease, biomarkers, cardiovascular imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory investigationsDiagnostic test
Laboratory investigations correlated with symptoms and imaging results
| Study group | Role | What they receive |
|---|---|---|
| Long-COVID | Patients with previous COVID-19 disease, and having long COVID symptoms 3 months after the active infection. Receives: Diagnostic Test: Laboratory investigations | |
| Post-COVID-19 without long-COVID syndrome | Patients with previous COVID-19 disease, without long COVID symptoms Receives: Diagnostic Test: Laboratory investigations | |
| IcMP (positive control) | Patients with ischemic heart disease without COVID-19 disease, and vaccinated at least with one injection Receives: Diagnostic Test: Laboratory investigations | |
| Healthy (negative control) | Healthy individuals without COVID-19 disease, and vaccinated at least with one injection Receives: Diagnostic Test: Laboratory investigations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in circulating biomarkers
circularRNA
Measured: 3 years
Secondary outcomes (4)
Change in circulating proteins
Proteomics
Measured: 3 years
Change in neutralizing antibodies
neutralizing antibodies
Measured: 3 years
Changes in ECGs
ECG signs
Measured: 3 years
Cardiac magnetic resonance imaging abnormalities
Pericardial effusion
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Apr 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Viral FatigueStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariann Gyongyosi, Medical University of Vienna
- Investigators
- Mariann Gyöngyösi, MD PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398952
- Sponsor's protocol ID
- Protocol Version 2
- Acronym
- POSTCOV
- Status last verified
- Jun 2022
- First submitted
- 31 May 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon reasonable request; after signature of the Data Sharing Agreement
Publications
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.
PubMed 38137533Gyongyosi 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.
PubMed 37773184
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-COVID-19 Outpatient Care and Biomarkers for Persisting Symptoms of Post-COVID-19 Disease - A Prospective Registry and Biobank
- ClinicalTrials.gov ID
- NCT05398952
- Acronym / sponsor ID
- POSTCOV / Protocol Version 2
- Conditions
- Post Viral Fatigue, Viral Myocarditis, POTS
- Keywords
- long/post-COVID, multiorgan disease, biomarkers, cardiovascular imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Long-COVID | – | Diagnostic Test: Laboratory investigationsPatients with previous COVID-19 disease, and having long COVID symptoms 3 months after the active infection. |
| Post-COVID-19 without long-COVID syndrome | – | Diagnostic Test: Laboratory investigationsPatients with previous COVID-19 disease, without long COVID symptoms |
| IcMP (positive control) | – | Diagnostic Test: Laboratory investigationsPatients with ischemic heart disease without COVID-19 disease, and vaccinated at least with one injection |
| Healthy (negative control) | – | Diagnostic Test: Laboratory investigationsHealthy individuals without COVID-19 disease, and vaccinated at least with one injection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Age≥18to90years
- Proven infection by SARS-CoV2, at least 3 weeks after recovery from the infection
- Signed informed consent For HFrEF patient group:
- Full vaccination against SARS-CoV2 at least 3 weeks before inclusion in the study
- Signed informed consent
Key exclusion criteria (4 listed)
- non-willingness to participate or withdrawal of informed consent
- Clinically confirmed HFrEF (EF <40%)
- participation in any SARS-CoV-2 medical treatment trial
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory investigationsLaboratory investigations correlated with symptoms and imaging results | Diagnostic test | Healthy (negative control), IcMP (positive control), Long-COVID, Post-COVID-19 without long-COVID syndrome |
Primary outcome
Change in circulating biomarkers
Time frame: 3 years
circularRNA
4 secondary outcomes
Change in circulating proteins
Time frame: 3 years
Change in neutralizing antibodies
Time frame: 3 years
Changes in ECGs
Time frame: 3 years
Cardiac magnetic resonance imaging abnormalities
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Derived from this study: PubMed 38137533Gyongyosi 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.
- Derived from this study: PubMed 37773184Gyongyosi 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.
- Individual participant dataSharing planned: Yes. upon reasonable request; after signature of the Data Sharing Agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariann Gyöngyösi, MD PhD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Viral Fatigue and Viral Myocarditis, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariann Gyöngyösi, MD PhD (+4314040046140, mariann.gyongyosi@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in circulating biomarkers (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05398952, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.