SARS-CoV-2 InfectionNCT06318208
Pulmonary Function in Non-hospitalized Adults and Children After Mild COVID-19
An observational study of SARS-CoV-2 Infection, run by University of Rostock at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- lung function testing
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- 20 Apr 2021to 3 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: SARS-Covid -2 Infection 1 months before investigation
Who may be able to join
- SARS-CoV-2 Infection, non-hospitalized during infection
Who cannot join
- Smoking, existing lung disease (COPD, Asthma bronchiale)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Kinder- und Jugendklinik Universitätsmedizin Rostock
Rostock, 18057
About this study
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.
Read more
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.
Read the 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.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- lung function testing
- Keywords
- mild COVID-19, LCI, lung function, non-hospitalized COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung function testingDiagnostic test
lung function testing including LCI, FEV1, FVC, DLCO
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function
Pulmonary function after SARS-CoV-2 Infection
Measured: 4.3 - 11.3 weeks after positive PCR for SARS-CoV-2
Secondary outcomes (2)
Changes in pulmonary function
Changes in pulmonary function towards the follow-up
Measured: 11.0 - 16.7 weeks after the first lung function testing
Sociodemographic factors
Relation of pulmonary function to sociodemographic factors
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start20 Apr 2021
- Primary completion3 Jan 2022
- Study completion3 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Rachel Görges, University of Rostock
- Investigators
- Manfred Ballmann, Prof. Dr., Study director, UMR Kinder- und Jugendklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318208
- Sponsor's protocol ID
- C-LCI
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41199209
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Function in Non-hospitalized Adults and Children After Mild COVID-19
- ClinicalTrials.gov ID
- NCT06318208
- Acronym / sponsor ID
- C-LCI
- Conditions
- SARS-CoV-2 Infection
- Keywords
- mild COVID-19, LCI, lung function, non-hospitalized COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- SARS-Covid -2 Infection 1 months before investigation
Key inclusion criteria (1 listed)
- SARS-CoV-2 Infection, non-hospitalized during infection
Key exclusion criteria (1 listed)
- Smoking, existing lung disease (COPD, Asthma bronchiale)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lung function testinglung function testing including LCI, FEV1, FVC, DLCO | Diagnostic test | – |
Primary outcome
Pulmonary function
Time frame: 4.3 - 11.3 weeks after positive PCR for SARS-CoV-2
Pulmonary function after SARS-CoV-2 Infection
2 secondary outcomes
Changes in pulmonary function
Time frame: 11.0 - 16.7 weeks after the first lung function testing
Sociodemographic factors
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Derived from this study: PubMed 41199209Gorges 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Ballmann, Prof. Dr. study director
UMR Kinder- und Jugendklinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Infection, run by University of Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function (time frame: 4.3 - 11.3 weeks after positive PCR for SARS-CoV-2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06318208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.