Pulmonary Function in Non-hospitalized Adults and Children After Mild COVID-19

March 24, 2024 updated by: Alexandra Rachel Görges, University of Rostock

The study investigates whether patients with mild SARS-CoV-2 infection, who stayed at home during their infection and weren't hospitalized, have any persisting sequelae in pulmonary function.

Therefore, 110 patients, aged 6-60 years, were recruited by telephone 4-12 weeks after laboratory-confirmed positive PCR and invited for a lung function testing. Every patient with abnormalities in pulmonary function was invited to a follow-up 3 months after the first appointment to assess changes in lung function values.

Patients with a pre-existing lung disease and smokers within the last five years were excluded beforehand.

Additionally to lung function testing we did a throat swab at each appointment to analyse via Multiplex PCR whether the patients had any other respiratory infection at the time of the pulmonary function testing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

110 patients, 90 adults and 20 children, were recruited. The lung function included LCI, FEV1, FVC and DLCO (Hb corrected). Additionally we did a throat swab at each appointment to analyse via Multiplex PCR whether the patients had any other respiratory infection at the time of the test.

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

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

Study Locations

  • Germany
      • Rostock, Germany, 18057
        • Kinder- und Jugendklinik Universitätsmedizin Rostock

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

SARS-Covid -2 Infection 1 months before investigation

Description

Inclusion Criteria:

  • SARS-CoV-2 Infection, non-hospitalized during infection

Exclusion Criteria:

  • Smoking, existing lung disease (COPD, Asthma bronchiale)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function
Time Frame: 4.3 - 11.3 weeks after positive PCR for SARS-CoV-2
Pulmonary function after SARS-CoV-2 Infection
4.3 - 11.3 weeks after positive PCR for SARS-CoV-2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in pulmonary function
Time Frame: 11.0 - 16.7 weeks after the first lung function testing
Changes in pulmonary function towards the follow-up
11.0 - 16.7 weeks after the first lung function testing
Sociodemographic factors
Time Frame: 9 months
Relation of pulmonary function to sociodemographic factors
9 months

Collaborators and Investigators

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

Sponsor

University of Rostock

Investigators

  • Study Director: Manfred Ballmann, Prof. Dr., UMR Kinder- und Jugendklinik

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)

April 20, 2021

Primary Completion (Actual)

January 3, 2022

Study Completion (Actual)

January 3, 2022

Study Registration Dates

First Submitted

March 17, 2024

First Submitted That Met QC Criteria

March 17, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 24, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-LCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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