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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04401163
Enrollment
218
Registered
2020-05-26
Start date
2020-06-18
Completion date
2022-08-01
Last updated
2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Sars-CoV2

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTImaging of the lungs

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.

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Imaging of the lungs3 months after dischargeExpert evaluation
Pulmonary function tests3 months after dischargeLiter
Six-minute walk testPerformed 3 months after dischargeWalking distance (meters) and change in oxygen saturation.

Secondary

MeasureTime frameDescription
Hospital anxiety and Depression score (HADS)3 months after discharge0-21. The higher the score, the more risk of anxiety or depression.
Comorbidities12 months after dischargeAny pre-COVID-19 comorbidity and treatment with immmunosuppressants will be registered.
Short Form-36 (SF-36) questionnaire3 months after discharge0-100 scale. The lower the score, the more disability.
Biobanking of blood3 months after dischargeKnowledge regarding COVID19 is drastically evolving. Biobanking makes it possible to investigate blood samples in the future corresponding to ongoing evidence.
Blood sample at routine follow up.3 months after dischargeChange in outcomes between discharge and follow-up visits will be evaluated
Fatigue Assessment Score3 months after discharge10-50 score. The higher the score, the more fatigue
Cognitive sore (MOCA)3 months after discharge0-30. The lower the score, the more cognitive impairment

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026