NCT06318208

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 20, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

March 17, 2024

Last Update Submit

March 24, 2024

Conditions

Keywords

mild COVID-19LCIlung functionnon-hospitalized COVID-19

Outcome Measures

Primary Outcomes (1)

  • Pulmonary function

    Pulmonary function after SARS-CoV-2 Infection

    4.3 - 11.3 weeks after positive PCR for SARS-CoV-2

Secondary Outcomes (2)

  • Changes in pulmonary function

    11.0 - 16.7 weeks after the first lung function testing

  • Sociodemographic factors

    9 months

Interventions

lung function testingDIAGNOSTIC_TEST

lung function testing including LCI, FEV1, FVC, DLCO

Eligibility Criteria

Age6 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

SARS-Covid -2 Infection 1 months before investigation

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kinder- und Jugendklinik Universitätsmedizin Rostock

Rostock, 18057, Germany

Location

Related Publications (1)

  • Gorges AR, Warnke P, Lobermann M, Zapf A, Weitzel J, Steinbach ML, Zufle-Lemke N, Fischer DC, Ballmann M. Pulmonary function in non-hospitalized adults and children after mild COVID-19: a single-centre prospective cohort study. BMC Pulm Med. 2025 Nov 6;25(1):511. doi: 10.1186/s12890-025-04007-y.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Manfred Ballmann, Prof. Dr.

    UMR Kinder- und Jugendklinik

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 17, 2024

First Posted

March 19, 2024

Study Start

April 20, 2021

Primary Completion

January 3, 2022

Study Completion

January 3, 2022

Last Updated

March 26, 2024

Record last verified: 2024-03

Locations