NCT04401163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

June 18, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

May 12, 2023

Status Verified

November 1, 2022

Enrollment Period

1.3 years

First QC Date

May 12, 2020

Last Update Submit

May 10, 2023

Conditions

Sars-CoV2Covid19

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (13)

  • Short Form-36 (SF-36) questionnaire

    3 months after discharge

  • Short Form-36 (SF-36) questionnaire

    12 months after discharge

  • Fatigue Assessment Score

    3 months after discharge

  • Fatigue Assessment Score

    12 months after discharge

  • Cognitive sore (MOCA)

    3 months after discharge

  • +8 more secondary outcomes

Interventions

Imaging of the lungsDIAGNOSTIC_TEST

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.

Also known as: Blood sampling, Health related quality of life measurements, Pulmonary function tests

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Infection with Sars-CoV-2

You may not qualify if:

  • Unable to attend hospital visits due to frailty or severe disease
  • Unable to understand and complete questionnaires due to intellectual or language limitations / deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Aarhus University Hospital

Aarhus, Denmark

Location

Regional Hospital, Holstebro

Holstebro, Denmark

Location

Regional Hospital, Horsens

Horsens, Denmark

Location

Regional Hospital, Randers

Randers, Denmark

Location

Regional Hospital, Silkeborg

Silkeborg, Denmark

Location

Regional Hospital, Viborg

Viborg, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen CollectionRespiratory Function Tests

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesDiagnostic Techniques, Respiratory System

Study Officials

  • Elisabeth Bendstrup, MD, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 26, 2020

Study Start

June 18, 2020

Primary Completion

October 1, 2021

Study Completion

August 1, 2022

Last Updated

May 12, 2023

Record last verified: 2022-11

Locations

DK(6)