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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401163
• Other study ID #: 33510
• Status: Completed
• Start date: June 18, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: November 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: August 1, 2022
• Est. primary completion date: October 1, 2021
• 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

Related Conditions & MeSH terms

• Covid19
• Infections
• Sars-CoV2

Intervention

Diagnostic Test:
• Imaging 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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