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

May 10, 2023 updated by: University of Aarhus
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Søren S Haugen, MD
  • Phone Number: 004526182724
  • Email: sonpde@rm.dk

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Imaging of the lungs
Time Frame: 3 months after discharge
Expert evaluation
3 months after discharge
Imaging of the lungs
Time Frame: 12 months after discharge
Expert evaluation
12 months after discharge
Pulmonary function tests
Time Frame: 3 months after discharge
Liter
3 months after discharge
Pulmonary function tests
Time Frame: 12 months after discharge
Liter
12 months after discharge
Six-minute walk test
Time Frame: Performed 3 months after discharge
Walking distance (meters) and change in oxygen saturation.
Performed 3 months after discharge
Six-minute walk test
Time Frame: Performed 12 months after discharge
Walking distance (meters) and change in oxygen saturation.
Performed 12 months after discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Short Form-36 (SF-36) questionnaire
Time Frame: 3 months after discharge
0-100 scale. The lower the score, the more disability.
3 months after discharge
Short Form-36 (SF-36) questionnaire
Time Frame: 12 months after discharge
0-100 scale. The lower the score, the more disability.
12 months after discharge
Fatigue Assessment Score
Time Frame: 3 months after discharge
10-50 score. The higher the score, the more fatigue
3 months after discharge
Fatigue Assessment Score
Time Frame: 12 months after discharge
10-50 score. The higher the score, the more fatigue
12 months after discharge
Cognitive sore (MOCA)
Time Frame: 3 months after discharge
0-30. The lower the score, the more cognitive impairment
3 months after discharge
Cognitive sore (MOCA)
Time Frame: 12 months after discharge
0-30. The lower the score, the more cognitive impairment
12 months after discharge
Hospital anxiety and Depression score (HADS)
Time Frame: 3 months after discharge
0-21. The higher the score, the more risk of anxiety or depression.
3 months after discharge
Hospital anxiety and Depression score (HADS)
Time Frame: 12 months after discharge
0-21. The higher the score, the more risk of anxiety or depression.
12 months after discharge
Comorbidities
Time Frame: 12 months after discharge
Any pre-COVID-19 comorbidity and treatment with immmunosuppressants will be registered.
12 months after discharge
Blood sample at routine follow up.
Time Frame: 3 months after discharge
Change in outcomes between discharge and follow-up visits will be evaluated
3 months after discharge
Blood sample at routine follow up.
Time Frame: 12 months after discharge
Change in outcomes between discharge and follow-up visits will be evaluated
12 months after discharge
Biobanking of blood
Time Frame: 3 months after discharge
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
Time Frame: 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.
12 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elisabeth Bendstrup, MD, PhD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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