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

SARS-CoV-2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06318208
• Other study ID #: C-LCI
• Status: Completed
• Start date: April 20, 2021
• Est. completion date: January 3, 2022

Study information

• Verified date: March 2024
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 3, 2022
• Est. primary completion date: January 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Diagnostic Test:
• lung function testing
lung function testing including LCI, FEV1, FVC, DLCO

Locations

Country	Name	City	State
Germany	Kinder- und Jugendklinik Universitätsmedizin Rostock	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function	Pulmonary function after SARS-CoV-2 Infection	4.3 - 11.3 weeks after positive PCR for SARS-CoV-2
Secondary	Changes in pulmonary function	Changes in pulmonary function towards the follow-up	11.0 - 16.7 weeks after the first lung function testing
Secondary	Sociodemographic factors	Relation of pulmonary function to sociodemographic factors	9 months