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

NCT ID: NCT06318208

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2022-01-03

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

lung function testing

lung function testing including LCI, FEV1, FVC, DLCO

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rostock

OTHER

Sponsor Role: lead

Responsible Party

Alexandra Rachel Görges

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manfred Ballmann, Prof. Dr.

Role: STUDY_DIRECTOR

UMR Kinder- und Jugendklinik

Locations

Kinder- und Jugendklinik Universitätsmedizin Rostock

Rostock, , Germany

Countries

Germany

Other Identifiers

C-LCI

Identifier Type: -

Identifier Source: org_study_id