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OpenTrials
Completed

NCT Number: NCT06318208

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

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.

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Key information

Conditions

Sars-CoV-2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kinder- und Jugendklinik Universitätsmedizin Rostock

Rostock, 18057, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

lung function testing

Diagnostic Test

lung function testing including LCI, FEV1, FVC, DLCO

Primary outcomes

  1. Pulmonary function

    Time frame: 4.3 - 11.3 weeks after positive PCR for SARS-CoV-2

    Pulmonary function after SARS-CoV-2 Infection

Secondary outcomes

  1. Changes in pulmonary function

    Time frame: 11.0 - 16.7 weeks after the first lung function testing

    Changes in pulmonary function towards the follow-up

  2. Sociodemographic factors

    Time frame: 9 months

    Relation of pulmonary function to sociodemographic factors

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2024
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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