Clinical trial NCT04401163: Long-term Pulmonary Outcomes After Infection With Sars-CoV-2
Official title: Long-term Pulmonary Outcomes After Infection With Sars-CoV-2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
Covid19
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients hospitalized due to infection with Covid-19 and submitted from any of the five hospitals in the Central Denmark Region will be invited to participate.

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.

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

Primary outcomes:
measure: Imaging of the lungs
timeFrame: 3 months after discharge
measure: Imaging of the lungs
timeFrame: 12 months after discharge
measure: Pulmonary function tests
timeFrame: 3 months after discharge
measure: Pulmonary function tests
timeFrame: 12 months after discharge
measure: Six-minute walk test
timeFrame: Performed 3 months after discharge
measure: Six-minute walk test
timeFrame: Performed 12 months after discharge
Secondary outcomes:
measure: Short Form-36 (SF-36) questionnaire
timeFrame: 3 months after discharge
measure: Short Form-36 (SF-36) questionnaire
timeFrame: 12 months after discharge
measure: Fatigue Assessment Score
timeFrame: 3 months after discharge
measure: Fatigue Assessment Score
timeFrame: 12 months after discharge
measure: Cognitive sore (MOCA)
timeFrame: 3 months after discharge
measure: Cognitive sore (MOCA)
timeFrame: 12 months after discharge
measure: Hospital anxiety and Depression score (HADS)
timeFrame: 3 months after discharge
measure: Hospital anxiety and Depression score (HADS)
timeFrame: 12 months after discharge
measure: Comorbidities
timeFrame: 12 months after discharge
measure: Blood sample at routine follow up.
timeFrame: 3 months after discharge
measure: Blood sample at routine follow up.
timeFrame: 12 months after discharge
measure: Biobanking of blood
timeFrame: 3 months after discharge
measure: Biobanking of blood
timeFrame: 12 months after discharge
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Holstebro
country: Denmark
facility: Regional Hospital, Holstebro
city: Horsens
country: Denmark
facility: Regional Hospital, Horsens
city: Randers
country: Denmark
facility: Regional Hospital, Randers
city: Silkeborg
country: Denmark
facility: Regional Hospital, Silkeborg
city: Viborg
country: Denmark
facility: Regional Hospital, Viborg
Study officials:
affiliation: Aarhus University Hospital
name: Elisabeth Bendstrup, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: