Respiratory Function TestsNCT05812196
Late Respiratory Consequences of SARS-CoV-2 Pneumonia
An observational study of Respiratory Function Tests and Long COVID, run by Szeged University at 1 site in Hungary.
Trial summary
The goal of this observational study is to learn about the respiratory system in post-COVID syndrome. The main question aims to answer: how the post-COVID syndrome alters the lung function Participants will be asked to perform lung function tests. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Function Tests, Long COVID
- What is being tested?
- Lung function test and COVID infection
- How many people
- 60 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jan 2023to 31 Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients after COVID-19 infection. In the control group, healthy volunteers.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Barna Babik
Szeged, 6725
Barna Babik, 62545168, babikbarna@gmail.com
Ferenc Petak, PhD, DSc
About this study
Official title: Changes in the Respiratory System in Post-COVID Syndrome
The goal of this observational study is to learn about the respiratory system in post-COVID syndrome. The main question aims to answer:
how the post-COVID syndrome alters the lung function Participants will be asked to perform lung function tests. Researchers will compare post-COVID group to matched control healthy individuals.
- Conditions
- Respiratory Function Tests, Long COVID
- Being tested
- Lung function test, COVID infection
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung function testDiagnostic test
Spirometry to assess lung volumes, forced oscillations to measure respiratory mechanics, whole body plethysmography to assess static lung volumes and airway resistance, lung diffusion capacity measurements.
COVID infectionBiological
Verified COVID-19 infection.
| Study group | Role | What they receive |
|---|---|---|
| Post-COVID | Patients with COVID-19 infections. Receives: Diagnostic Test: Lung function test; Biological: COVID infection | |
| Control | Patients without earlier diagnosis of COVID-19. Receives: Diagnostic Test: Lung function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory mechanics
Mechanical properties of the airways and respiratory tissues
Measured: 6-12 months after COVID-19 infections
Secondary outcomes (3)
Spirometry
Forced expiratory lung volumes
Measured: 6-12 months after COVID-19 infections
Lung diffusion capacity
DLCO
Measured: 6-12 months after COVID-19 infections
Plethysmography
Measurement of functional residual capacity and airway resistance by using a whole body plethysmograph.
Measured: 6-12 months after COVID-19 infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (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 (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Function TestsStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barna Babik, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812196
- Sponsor's protocol ID
- Post-COVID-Szeged
- Status last verified
- May 2023
- First submitted
- 12 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palfi A, Balogh AL, Polonyi G, Schulcz D, Zollei E, Bari G, Fodor GH, Barath K, Somfay A, Petak F, Babik B. Post-COVID changes in lung function 6 months after veno-venous extracorporeal membrane oxygenation: a prospective observational clinical trial. Front Med (Lausanne). 2023 Dec 20;10:1288679. doi: 10.3389/fmed.2023.1288679. eCollection 2023.
PubMed 38173937
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Respiratory System in Post-COVID Syndrome
- ClinicalTrials.gov ID
- NCT05812196
- Acronym / sponsor ID
- Post-COVID-Szeged
- Conditions
- Respiratory Function Tests, Long COVID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Apr 2023 (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 goal of this observational study is to learn about the respiratory system in post-COVID syndrome. The main question aims to answer:
how the post-COVID syndrome alters the lung function Participants will be asked to perform lung function tests. Researchers will compare post-COVID group to matched control healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-COVID | – | Diagnostic Test: Lung function test, Biological: COVID infectionPatients with COVID-19 infections. |
| Control | – | Diagnostic Test: Lung function testPatients without earlier diagnosis of COVID-19. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients after COVID-19 infection. In the control group, healthy volunteers.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Lung function testSpirometry to assess lung volumes, forced oscillations to measure respiratory mechanics, whole body plethysmography to assess static lung volumes and airway resistance, lung diffusion capacity measurements. | Diagnostic test | Control, Post-COVID |
| COVID infectionVerified COVID-19 infection. | Biological | Post-COVID |
Primary outcome
Respiratory mechanics
Time frame: 6-12 months after COVID-19 infections
Mechanical properties of the airways and respiratory tissues
3 secondary outcomes
Spirometry
Time frame: 6-12 months after COVID-19 infections
Lung diffusion capacity
Time frame: 6-12 months after COVID-19 infections
Plethysmography
Time frame: 6-12 months after COVID-19 infections
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 38173937Palfi A, Balogh AL, Polonyi G, Schulcz D, Zollei E, Bari G, Fodor GH, Barath K, Somfay A, Petak F, Babik B. Post-COVID changes in lung function 6 months after veno-venous extracorporeal membrane oxygenation: a prospective observational clinical trial. Front Med (Lausanne). 2023 Dec 20;10:1288679. doi: 10.3389/fmed.2023.1288679. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
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 Respiratory Function Tests and Long COVID, run by Szeged University at 1 site in Hungary.
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 0 inclusion and 1 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 6 May 2023. 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 Hungary. 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 Barna Babik (0662545168, babikbarna@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory mechanics (time frame: 6-12 months after COVID-19 infections). 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 NCT05812196, which also lists 1 linked publication.
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 6 May 2023.