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

Completed

• Conditions: Sars-CoV2; Covid19

• Registration Number: NCT04401163
• Lead Sponsor: University of Aarhus

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-26
• Study Start: 2020-06-18
• Primary Completion: 2021-10-01
• Study Completion: 2022-08-01
• Status Verified: 2022-11
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

• Infection with Sars-CoV-2

Read More

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fatigue Assessment Score	12 months after discharge	10-50 score. The higher the score, the more fatigue
Cognitive sore (MOCA)	12 months after discharge	0-30. The lower the score, the more cognitive impairment
Biobanking of blood	12 months after discharge	Knowledge regarding COVID19 is drastically evolving. Biobanking makes it possible to investigate blood samples in the future corresponding to ongoing evidence.
Blood sample at routine follow up.	12 months after discharge	Change in outcomes between discharge and follow-up visits will be evaluated
Comorbidities	12 months after discharge	Any pre-COVID-19 comorbidity and treatment with immmunosuppressants will be registered.
Short Form-36 (SF-36) questionnaire	12 months after discharge	0-100 scale. The lower the score, the more disability.
Hospital anxiety and Depression score (HADS)	12 months after discharge	0-21. The higher the score, the more risk of anxiety or depression.

Trial Locations

Locations (6)

Regional Hospital, Horsens; 🇩🇰 Horsens, Denmark

Regional Hospital, Randers; 🇩🇰 Randers, Denmark

Regional Hospital, Viborg; 🇩🇰 Viborg, Denmark

Regional Hospital, Holstebro; 🇩🇰 Holstebro, Denmark

Regional Hospital, Silkeborg; 🇩🇰 Silkeborg, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark