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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Sars-CoV2
• Intervention / Treatment: Diagnostic test: Imaging of the lungs

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.

• Study Type: Observational
• Enrollment (Actual): 218

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Aarhus University Hospital
  • Holstebro, Denmark
    • Regional Hospital, Holstebro
  • Horsens, Denmark
    • Regional Hospital, Horsens
  • Randers, Denmark
    • Regional Hospital, Randers
  • Silkeborg, Denmark
    • Regional Hospital, Silkeborg
  • Viborg, Denmark
    • Regional Hospital, Viborg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imaging of the lungs	Expert evaluation	3 months after discharge
Imaging of the lungs	Expert evaluation	12 months after discharge
Pulmonary function tests	Liter	3 months after discharge
Pulmonary function tests	Liter	12 months after discharge
Six-minute walk test	Walking distance (meters) and change in oxygen saturation.	Performed 3 months after discharge
Six-minute walk test	Walking distance (meters) and change in oxygen saturation.	Performed 12 months after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form-36 (SF-36) questionnaire	0-100 scale. The lower the score, the more disability.	3 months after discharge
Short Form-36 (SF-36) questionnaire	0-100 scale. The lower the score, the more disability.	12 months after discharge
Fatigue Assessment Score	10-50 score. The higher the score, the more fatigue	3 months after discharge
Fatigue Assessment Score	10-50 score. The higher the score, the more fatigue	12 months after discharge
Cognitive sore (MOCA)	0-30. The lower the score, the more cognitive impairment	3 months after discharge
Cognitive sore (MOCA)	0-30. The lower the score, the more cognitive impairment	12 months after discharge
Hospital anxiety and Depression score (HADS)	0-21. The higher the score, the more risk of anxiety or depression.	3 months after discharge
Hospital anxiety and Depression score (HADS)	0-21. The higher the score, the more risk of anxiety or depression.	12 months after discharge
Comorbidities	Any pre-COVID-19 comorbidity and treatment with immmunosuppressants will be registered.	12 months after discharge
Blood sample at routine follow up.	Change in outcomes between discharge and follow-up visits will be evaluated	3 months after discharge
Blood sample at routine follow up.	Change in outcomes between discharge and follow-up visits will be evaluated	12 months after discharge
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
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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Elisabeth Bendstrup, MD, PhD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 33510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No