Post-COVID Respiratory Consequences

Sponsor

Szeged University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05812196

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Function Tests Long COVID	Diagnostic Test: Lung function test Biological: COVID infection

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Changes in the Respiratory System in Post-COVID Syndrome

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Post-COVID Patients with COVID-19 infections.	Diagnostic Test: Lung function 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. Biological: COVID infection Verified COVID-19 infection.
Control Patients without earlier diagnosis of COVID-19.	Diagnostic Test: Lung function 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.

Arm

Intervention/Treatment

Post-COVID

Patients with COVID-19 infections.

Diagnostic Test: Lung function 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.

Biological: COVID infection

Verified COVID-19 infection.

Control

Patients without earlier diagnosis of COVID-19.

Diagnostic Test: Lung function test

Outcome Measures

Primary Outcome Measures

Respiratory mechanics [6-12 months after COVID-19 infections]
Mechanical properties of the airways and respiratory tissues

Secondary Outcome Measures

Spirometry [6-12 months after COVID-19 infections]
Forced expiratory lung volumes
Lung diffusion capacity [6-12 months after COVID-19 infections]
DLCO
Plethysmography [6-12 months after COVID-19 infections]
Measurement of functional residual capacity and airway resistance by using a whole body plethysmograph.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria: COVID-19 infections in the post-COVID group. -

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barna Babik	Szeged		Hungary	6725

Sponsors and Collaborators

Szeged University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Barna Babik, Professor, Szeged University

ClinicalTrials.gov Identifier:

NCT05812196

Other Study ID Numbers:

Post-COVID-Szeged

First Posted:

Apr 13, 2023

Last Update Posted:

Apr 13, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 13, 2023