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Completed

NCT Number: NCT04401163

Long-term Pulmonary Outcomes After Infection With Sars-CoV-2

The objective of this study is to assess the long-term outcomes after hospital admission with Covid-19 with respect to pulmonary function, physical capacity, imaging, quality of life and socioeconomic outcomes.

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Key information

Conditions

Sars-CoV2 COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus, Denmark

Loading trial locations.

About this study

Patients will be invited to follow-up visits 3 and 12 months after hospitalization with COVID19.

Inclusion will take place during 2020. We expect to enroll 180 non-ICU patients and 36 ICU patients.

Who can participate

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

Inclusion criteria

  • Infection with Sars-CoV-2

Exclusion criteria

  • Unable to attend hospital visits due to frailty or severe disease
  • Unable to understand and complete questionnaires due to intellectual or language limitations / deficits

Treatment and study plan

Imaging of the lungs

Diagnostic Test

After hospital admissions with COVID19 patients will come for two clinical visits to complete a number of questionnaires, pulmonary function testing, six-minute walk test, blood sampling and imaging of the lungs.

Other names: Blood sampling, Health related quality of life measurements, Pulmonary function tests

Primary outcomes

  1. Imaging of the lungs

    Time frame: 3 months after discharge

    Expert evaluation

  2. Imaging of the lungs

    Time frame: 12 months after discharge

    Expert evaluation

  3. Pulmonary function tests

    Time frame: 3 months after discharge

    Liter

  4. Pulmonary function tests

    Time frame: 12 months after discharge

    Liter

  5. Six-minute walk test

    Time frame: Performed 3 months after discharge

    Walking distance (meters) and change in oxygen saturation.

  6. Six-minute walk test

    Time frame: Performed 12 months after discharge

    Walking distance (meters) and change in oxygen saturation.

Secondary outcomes

  1. Short Form-36 (SF-36) questionnaire

    Time frame: 3 months after discharge

    0-100 scale. The lower the score, the more disability.

  2. Short Form-36 (SF-36) questionnaire

    Time frame: 12 months after discharge

    0-100 scale. The lower the score, the more disability.

  3. Fatigue Assessment Score

    Time frame: 3 months after discharge

    10-50 score. The higher the score, the more fatigue

  4. Fatigue Assessment Score

    Time frame: 12 months after discharge

    10-50 score. The higher the score, the more fatigue

  5. Cognitive sore (MOCA)

    Time frame: 3 months after discharge

    0-30. The lower the score, the more cognitive impairment

  6. Cognitive sore (MOCA)

    Time frame: 12 months after discharge

    0-30. The lower the score, the more cognitive impairment

  7. Hospital anxiety and Depression score (HADS)

    Time frame: 3 months after discharge

    0-21. The higher the score, the more risk of anxiety or depression.

  8. Hospital anxiety and Depression score (HADS)

    Time frame: 12 months after discharge

    0-21. The higher the score, the more risk of anxiety or depression.

  9. Comorbidities

    Time frame: 12 months after discharge

    Any pre-COVID-19 comorbidity and treatment with immmunosuppressants will be registered.

  10. Blood sample at routine follow up.

    Time frame: 3 months after discharge

    Change in outcomes between discharge and follow-up visits will be evaluated

  11. Blood sample at routine follow up.

    Time frame: 12 months after discharge

    Change in outcomes between discharge and follow-up visits will be evaluated

  12. Biobanking of blood

    Time frame: 3 months after discharge

    Knowledge regarding COVID19 is drastically evolving. Biobanking makes it possible to investigate blood samples in the future corresponding to ongoing evidence.

  13. Biobanking of blood

    Time frame: 12 months after discharge

    Knowledge regarding COVID19 is drastically evolving. Biobanking makes it possible to investigate blood samples in the future corresponding to ongoing evidence.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 26, 2020
Registry last updated
May 12, 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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