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

Completed

• Conditions: SARS-CoV-2 Infection

• Registration Number: NCT06318208
• Lead Sponsor: University of Rostock

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.

Study Timeline

• Study Start: 2021-04-20
• Primary Completion: 2022-01-03
• Study Completion: 2022-01-03
• Status Verified: 2024-03
• Study First Submitted: 2024-03-17
• Study First Submitted QC: 2024-03-17
• Study First Posted: 2024-03-19
• Last Update Submitted: 2024-03-24
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary function	4.3 - 11.3 weeks after positive PCR for SARS-CoV-2	Pulmonary function after SARS-CoV-2 Infection

Secondary Outcome Measures

Name	Time	Method
Changes in pulmonary function	11.0 - 16.7 weeks after the first lung function testing	Changes in pulmonary function towards the follow-up
Sociodemographic factors	9 months	Relation of pulmonary function to sociodemographic factors

Trial Locations

Locations (1)

Kinder- und Jugendklinik Universitätsmedizin Rostock; 🇩🇪 Rostock, Germany