Late Respiratory Consequences of SARS-CoV-2 Pneumonia

May 2, 2023 updated by: Barna Babik, Szeged University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hungary
      • Szeged, Hungary, 6725
        • Recruiting
        • Barna Babik
        • Principal Investigator:
          • Ferenc Petak, PhD, DSc
        • Sub-Investigator:
          • Gergely Fodor, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Roberty Sudy, MD, PhD
        • Sub-Investigator:
          • Adam Balogh, MD, PhD
        • Sub-Investigator:
          • Almos Schranc, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory mechanics
Time Frame: 6-12 months after COVID-19 infections
Mechanical properties of the airways and respiratory tissues
6-12 months after COVID-19 infections

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Szeged University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Post-COVID-Szeged

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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