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Completed

NCT Number: NCT04581135

Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19

Prospective Observational Swiss Cohort Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19.

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Key information

Conditions

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

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Claraspital AG - Department of Pulmonary Medicine, Basel, Switzerland

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About this study

COVID-19 is a coronavirus induced viral pneumonia leading to Acute Respiratory Distress Syndrome. Previous coronavirus infections (SARS and MERS) led to pulmonary fibrosis in up to 30%. Prospective evaluation of lung abnormalities and pulmonary fibrosis after COVID-19 infection is crucial as novel treatments against lung fibrosis of different etiologies are available. No data on pulmonary longterm effects in COVID-19 survivors are currently available. The nation-wide Swiss COVID-19 lung group establishes a meticulously characterized prospective cohort study on pulmonary long-term sequela of patients living in Switzerland.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed written informed consent.
  • All adult patients with COVID-19 over 18 years.

Exclusion criteria

  • Severe mental or physical disability precluding informed consent or compliance with the protocol for prospective data collection.
  • Pregnancy.

Treatment and study plan

COVID-19

Other

Research project in which biological material is sampled and health-related personal data are collected and used for further research. Coded data are used.

Other names: Sampling biological material, Collection of health-related personal data

Primary outcomes

  1. Pulmonary follow-up sequelae in patients after COVID-19

    Time frame: 36 months

    Number of patients with the long-term pulmonary complications by measuring lung function, exercise testing and radiological Imaging

  2. Evaluation of risk factors for adverse Outcome after COVID-19

    Time frame: 36 months

    Number of patients with risk factors including comorbidities and other cofactors and correlate them to adverse outcome in patients after COVID-19

Secondary outcomes

  1. Compare the functional Pulmonary outcome of COVID-19 disease

    Time frame: 36 months

    Compare pulmonary function measurements between mild and moderate to severe and critical COVID-19 disease

  2. Compare the radiological Pulmonary outcome of COVID-19 disease

    Time frame: 36 months

    Compare imaging measurements between mild and moderate to severe and critical COVID-19 disease

  3. Quality of Life after COVID-19

    Time frame: 36 months

    Compare Quality of Life questionnaires between mild and moderate to severe and critical COVID-19 disease

  4. Physical performance after COVID-19 using Clinical Frailty Scale

    Time frame: 36 months

    To observe and compare the physical performance after COVID-19 via the Clinical Frailty Scale between mild and moderate to severe and critical COVID-19 disease

  5. Physical performance after COVID-19 using frailty assessment tests

    Time frame: 36 months

    To observe and compare the physical performance after COVID-19 via frailty assessment tests between mild and moderate to severe and critical COVID-19 disease

  6. Microbiota and COVID-19

    Time frame: 36 months

    Number of patients with changes in microbiota in response to COVID-19 by microbiota analysis of sputa, bronchoalveolar lavage and swaps

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Prospective Observational Cohort Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2020
Registry last updated
Mar 14, 2023

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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