NCT05812196

Brief 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. Researchers will compare post-COVID group to matched control healthy individuals.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

April 12, 2023

Last Update Submit

May 2, 2023

Conditions

Respiratory Function TestsLong COVID

Outcome Measures

Primary Outcomes (1)

  • Respiratory mechanics

    Mechanical properties of the airways and respiratory tissues

    6-12 months after COVID-19 infections

Secondary Outcomes (3)

  • Spirometry

    6-12 months after COVID-19 infections

  • Lung diffusion capacity

    6-12 months after COVID-19 infections

  • Plethysmography

    6-12 months after COVID-19 infections

Study Arms (2)

Post-COVID

Patients with COVID-19 infections.

Diagnostic Test: Lung function testBiological: COVID infection

Control

Patients without earlier diagnosis of COVID-19.

Diagnostic Test: Lung function test

Interventions

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.

ControlPost-COVID
COVID infectionBIOLOGICAL

Verified COVID-19 infection.

Post-COVID

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients after COVID-19 infection. In the control group, healthy volunteers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barna Babik

Szeged, 6725, Hungary

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38173937DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Barna Babik

CONTACT

0662545168babikbarna@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 13, 2023

Study Start

January 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)