Sars-CoV2NCT04401163
Long-term Pulmonary Outcomes After Infection With Sars-CoV-2
An observational study of Sars-CoV2 and Covid19, run by University of Aarhus at 6 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Imaging of the lungs
- How many people
- 218 participants
- Where
- 6 sitesDenmark
- Study dates
- 18 Jun 2020to 1 Aug 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Infection with Sars-CoV-2
Who cannot join
- Unable to attend hospital visits due to frailty or severe disease
- Unable to understand and complete questionnaires due to intellectual or language limitations / deficits
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
Aarhus University Hospital
Aarhus
Regional Hospital, Holstebro
Holstebro
Regional Hospital, Horsens
Horsens
Regional Hospital, Randers
Randers
Regional Hospital, Silkeborg
Silkeborg
Regional Hospital, Viborg
Viborg
About this study
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.
Read the 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.
- Being tested
- Imaging of the lungs
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging of the lungsDiagnostic test
Also called Blood sampling, Health related quality of life measurements, Pulmonary function tests
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging of the lungs
Expert evaluation
Measured: 3 months after discharge
Imaging of the lungs
Expert evaluation
Measured: 12 months after discharge
Pulmonary function tests
Liter
Measured: 3 months after discharge
Pulmonary function tests
Liter
Measured: 12 months after discharge
Six-minute walk test
Walking distance (meters) and change in oxygen saturation.
Measured: Performed 3 months after discharge
Six-minute walk test
Walking distance (meters) and change in oxygen saturation.
Measured: Performed 12 months after discharge
Secondary outcomes (13)
Short Form-36 (SF-36) questionnaire
0-100 scale. The lower the score, the more disability.
Measured: 3 months after discharge
Short Form-36 (SF-36) questionnaire
0-100 scale. The lower the score, the more disability.
Measured: 12 months after discharge
Fatigue Assessment Score
10-50 score. The higher the score, the more fatigue
Measured: 3 months after discharge
Fatigue Assessment Score
10-50 score. The higher the score, the more fatigue
Measured: 12 months after discharge
Cognitive sore (MOCA)
0-30. The lower the score, the more cognitive impairment
Measured: 3 months after discharge
Cognitive sore (MOCA)
0-30. The lower the score, the more cognitive impairment
Measured: 12 months after discharge
Hospital anxiety and Depression score (HADS)
0-21. The higher the score, the more risk of anxiety or depression.
Measured: 3 months after discharge
Hospital anxiety and Depression score (HADS)
0-21. The higher the score, the more risk of anxiety or depression.
Measured: 12 months after discharge
Comorbidities
Any pre-COVID-19 comorbidity and treatment with immmunosuppressants will be registered.
Measured: 12 months after discharge
Blood sample at routine follow up.
Change in outcomes between discharge and follow-up visits will be evaluated
Measured: 3 months after discharge
Blood sample at routine follow up.
Change in outcomes between discharge and follow-up visits will be evaluated
Measured: 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.
Measured: 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.
Measured: 12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start18 Jun 2020
- Primary completion1 Oct 2021
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 218 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Bendstrup, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401163
- Sponsor's protocol ID
- 33510
- Status last verified
- Nov 2022
- First submitted
- 12 May 2020
- Last updated
- 12 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Pulmonary Outcomes After Infection With Sars-CoV-2
- ClinicalTrials.gov ID
- NCT04401163
- Acronym / sponsor ID
- 33510
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Infection with Sars-CoV-2
Key exclusion criteria (2 listed)
- Unable to attend hospital visits due to frailty or severe disease
- Unable to understand and complete questionnaires due to intellectual or language limitations / deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging of the lungsAlso: Blood sampling, Health related quality of life measurements, Pulmonary function testsAfter 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. | Diagnostic test | – |
Primary outcome
Imaging of the lungs
Time frame: 3 months after discharge
Expert evaluation
Imaging of the lungs
Time frame: 12 months after discharge
Expert evaluation
Pulmonary function tests
Time frame: 3 months after discharge
Liter
Pulmonary function tests
Time frame: 12 months after discharge
Liter
Six-minute walk test
Time frame: Performed 3 months after discharge
Walking distance (meters) and change in oxygen saturation.
Six-minute walk test
Time frame: Performed 12 months after discharge
Walking distance (meters) and change in oxygen saturation.
13 secondary outcomes
Short Form-36 (SF-36) questionnaire
Time frame: 3 months after discharge
Short Form-36 (SF-36) questionnaire
Time frame: 12 months after discharge
Fatigue Assessment Score
Time frame: 3 months after discharge
Fatigue Assessment Score
Time frame: 12 months after discharge
Cognitive sore (MOCA)
Time frame: 3 months after discharge
Cognitive sore (MOCA)
Time frame: 12 months after discharge
Hospital anxiety and Depression score (HADS)
Time frame: 3 months after discharge
Hospital anxiety and Depression score (HADS)
Time frame: 12 months after discharge
Comorbidities
Time frame: 12 months after discharge
Blood sample at routine follow up.
Time frame: 3 months after discharge
Blood sample at routine follow up.
Time frame: 12 months after discharge
Biobanking of blood
Time frame: 3 months after discharge
Biobanking of blood
Time frame: 12 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Bendstrup, MD, PhD principal investigator
Aarhus University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sars-CoV2 and Covid19, run by University of Aarhus at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging of the lungs (time frame: 3 months after discharge). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.