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Clinical Trials/NCT04401163
NCT04401163
Completed
Not Applicable

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

University of Aarhus6 sites in 1 country218 target enrollmentJune 18, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sars-CoV2
Sponsor
University of Aarhus
Enrollment
218
Locations
6
Primary Endpoint
Six-minute walk test
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 18, 2020
End Date
August 1, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Six-minute walk test

Time Frame: Performed 12 months after discharge

Walking distance (meters) and change in oxygen saturation.

Pulmonary function tests

Time Frame: 12 months after discharge

Liter

Imaging of the lungs

Time Frame: 12 months after discharge

Expert evaluation

Secondary Outcomes

  • Fatigue Assessment Score(12 months after discharge)
  • Cognitive sore (MOCA)(12 months after discharge)
  • Biobanking of blood(12 months after discharge)
  • Blood sample at routine follow up.(12 months after discharge)
  • Comorbidities(12 months after discharge)
  • Short Form-36 (SF-36) questionnaire(12 months after discharge)
  • Hospital anxiety and Depression score (HADS)(12 months after discharge)

Study Sites (6)

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