Covid19 Clinical Trial
Official title:
Long-term Pulmonary Outcomes After Infection With Sars-CoV-2
NCT number | NCT04401163 |
Other study ID # | 33510 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 18, 2020 |
Est. completion date | August 1, 2022 |
Verified date | November 2022 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 218 |
Est. completion date | August 1, 2022 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus | |
Denmark | Regional Hospital, Holstebro | Holstebro | |
Denmark | Regional Hospital, Horsens | Horsens | |
Denmark | Regional Hospital, Randers | Randers | |
Denmark | Regional Hospital, Silkeborg | Silkeborg | |
Denmark | Regional Hospital, Viborg | Viborg |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Imaging of the lungs | Expert evaluation | 3 months after discharge | |
Primary | Imaging of the lungs | Expert evaluation | 12 months after discharge | |
Primary | Pulmonary function tests | Liter | 3 months after discharge | |
Primary | Pulmonary function tests | Liter | 12 months after discharge | |
Primary | Six-minute walk test | Walking distance (meters) and change in oxygen saturation. | Performed 3 months after discharge | |
Primary | Six-minute walk test | Walking distance (meters) and change in oxygen saturation. | Performed 12 months after discharge | |
Secondary | Short Form-36 (SF-36) questionnaire | 0-100 scale. The lower the score, the more disability. | 3 months after discharge | |
Secondary | Short Form-36 (SF-36) questionnaire | 0-100 scale. The lower the score, the more disability. | 12 months after discharge | |
Secondary | Fatigue Assessment Score | 10-50 score. The higher the score, the more fatigue | 3 months after discharge | |
Secondary | Fatigue Assessment Score | 10-50 score. The higher the score, the more fatigue | 12 months after discharge | |
Secondary | Cognitive sore (MOCA) | 0-30. The lower the score, the more cognitive impairment | 3 months after discharge | |
Secondary | Cognitive sore (MOCA) | 0-30. The lower the score, the more cognitive impairment | 12 months after discharge | |
Secondary | Hospital anxiety and Depression score (HADS) | 0-21. The higher the score, the more risk of anxiety or depression. | 3 months after discharge | |
Secondary | Hospital anxiety and Depression score (HADS) | 0-21. The higher the score, the more risk of anxiety or depression. | 12 months after discharge | |
Secondary | Comorbidities | Any pre-COVID-19 comorbidity and treatment with immmunosuppressants will be registered. | 12 months after discharge | |
Secondary | Blood sample at routine follow up. | Change in outcomes between discharge and follow-up visits will be evaluated | 3 months after discharge | |
Secondary | Blood sample at routine follow up. | Change in outcomes between discharge and follow-up visits will be evaluated | 12 months after discharge | |
Secondary | Biobanking of blood | Knowledge regarding COVID19 is drastically evolving. Biobanking makes it possible to investigate blood samples in the future corresponding to ongoing evidence. | 3 months after discharge | |
Secondary | Biobanking of blood | Knowledge regarding COVID19 is drastically evolving. Biobanking makes it possible to investigate blood samples in the future corresponding to ongoing evidence. | 12 months after discharge |
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