Covid19NCT05054608
Long Term Outcome in ICU Treated COVID-19: Return to Work
An observational study of Covid19, run by Uppsala University at 1 site in Sweden.
Trial summary
Return to work (not being on sick leave) within one year after intensive care unit (ICU) admission with Coronavirus disease 2019 (COVID-19) will be assessed. Risk and risk factors for not having returned to work will be compared to patients admitted to hospital and general population controls. Read more about this study
- Who is it for?
- Ages 18 to 63 years
- Conditions the study is for
- Covid19
- How many people
- 13,537 participants
- Where
- 1 siteSweden
- Study dates
- 15 Oct 2021to 15 Nov 2021
- 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 63 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population consists of all patients a fulfilling the eligibility criteria.
Who may be able to join
- Admitted to a Swedish ICU and registered in the Swedish intensive care registry with the ICD 10 diagnosis U07.1 before 31 July 2020. ICU group.
- or Admitted to hospital but not ICU with the ICD-10 diagnosis U07.1 in the national patient registry before 31 July 2020. Hospital group.
- or randomly selected from the general population (and not included in the ICU or hospital admitted cohorts), matched on age, legal gender and region (four per ICU patient). Population control group
Who cannot join
- Death within one year of inclusion. (For analysis of the secondary outcome). Missing a Swedish personal identification number
Trial locations and contacts
1 site in 1 country.
About this study
Return to work (not being on sick leave) within one year after intensive care unit (ICU) admission with Coronavirus disease 2019 (COVID-19) will be assessed. Risk and risk factors for not having returned to work will be compared to patients admitted to hospital and general population controls.
The ICU population comprises all Swedish ICU patients with COVID-19 with at least one year of follow up. The hospital admitted cohort comprises four hospital admitted patients with COVID-19 per ICU patient, matched on age, legal gender and region. The general population controls are matched to the ICU patients in a one to four fashion on age, legal gender and region.
ICU patients are identified in the Swedish intensive care registry. The hospital admitted patients are identified in the national patient registry and the population controls are identified in the population registry. Data on socioeconomics and income are provided by the Statistics Sweden. Data on comorbidity, medications and death are provided from the National board of health and welfare. Finally, data on sick leave are provided from the Swedish Social Insurance Agency.
- Conditions
- Covid19
- Being tested
- No intervention
- Keywords
- Long term outcome, Return to work, COVID-19, Risk factors, Critical care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study. No intervention.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 ICU cohort | All patients, 18 to 63 years old, admitted to a Swedish ICU with COVID-19 with at least one year of follow up. COVID-19 defined by the ICD-10 diagnosis U07.1 in the nationwide Swedish intensive care registry. Receives: Other: No intervention | |
| COVID-19 hospital admission control cohort | Four random control patients per ICU patient matched on age legal gender and region. Controls selected from all patients admitted to a Swedish hospital with COVID-19 with at least one year of follow up. Not including patients in the COVID-19 ICU cohort. COVID-19 defined by the ICD-10 diagnosis U07.1 in the nationwide Swedish national patient registry. Receives: Other: No intervention | |
| General population control cohort | Four general population controls per ICU patient, matched on age, legal gender and region drawn from the total population register of Sweden. Not including ICU and hospital admitted COVID-19 patients. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is group an independent risk factor for having one or more additional sick leave free days alive? Ordinal logistic model including variables below.
Variables in binary logistic model: On sick leave one year before ICU admission, Charlson comorbidity index, age, legal gender, highest education, immigrant background, income the year before inclusion, marital status, group (ICU, Hospital or General population).
Measured: One year
Secondary outcomes (1)
Is cohort an independent risk factor for being on sick leave one year after inclusion? Binary logistic model containing the variables below?
Variables in linear regression model: On sick leave one year before ICU admission, Charlson comorbidity index, age, legal gender, highest education, immigrant background, income the year before inclusion, marital status, group (ICU, Hospital or General population).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start15 Oct 2021
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 13,537 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Dalarna County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Miklos Lipcsey, Professor, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054608
- Sponsor's protocol ID
- U1111-1269-5745
- Status last verified
- Nov 2022
- First submitted
- 20 Sep 2021
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing is not allowed under the ethical review approval.
Publications
Ahlstrom B, Frithiof R, Marks-Hultstrom M, Larsson IM, Strandberg G, Lipcsey M. The 1-Year Functional Recovery From Severe COVID-19 in a Swedish Working-Age Cohort. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70058. doi: 10.1111/aas.70058.
PubMed 40356220
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcome in ICU Treated COVID-19: Return to Work
- ClinicalTrials.gov ID
- NCT05054608
- Acronym / sponsor ID
- U1111-1269-5745
- Conditions
- Covid19
- Keywords
- Long term outcome, Return to work, COVID-19, Risk factors, Critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,537 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Dalarna County Council, Sweden
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 23 Sep 2021 (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.
Return to work (not being on sick leave) within one year after intensive care unit (ICU) admission with Coronavirus disease 2019 (COVID-19) will be assessed. Risk and risk factors for not having returned to work will be compared to patients admitted to hospital and general population controls.
The ICU population comprises all Swedish ICU patients with COVID-19 with at least one year of follow up. The hospital admitted cohort comprises four hospital admitted patients with COVID-19 per ICU patient, matched on age, legal gender and region. The general population controls are matched to the ICU patients in a one to four fashion on age, legal gender and region.
ICU patients are identified in the Swedish intensive care registry. The hospital admitted patients are identified in the national patient registry and the population controls are identified in the population registry. Data on socioeconomics and income are provided by the Statistics Sweden. Data on comorbidity, medications and death are provided from the National board of health and welfare. Finally, data on sick leave are provided from the Swedish Social Insurance Agency.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 ICU cohort | – | Other: No interventionAll patients, 18 to 63 years old, admitted to a Swedish ICU with COVID-19 with at least one year of follow up. COVID-19 defined by the ICD-10 diagnosis U07.1 in the nationwide Swedish intensive care registry. |
| COVID-19 hospital admission control cohort | – | Other: No interventionFour random control patients per ICU patient matched on age legal gender and region. Controls selected from all patients admitted to a Swedish hospital with COVID-19 with at least one year of follow up. Not including patients in the COVID-19 ICU cohort. COVID-19 defined by the ICD-10 diagnosis U07.1 in the nationwide Swedish national patient registry. |
| General population control cohort | – | Other: No interventionFour general population controls per ICU patient, matched on age, legal gender and region drawn from the total population register of Sweden. Not including ICU and hospital admitted COVID-19 patients. |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of all patients a fulfilling the eligibility criteria.
Key inclusion criteria (3 listed)
- Admitted to a Swedish ICU and registered in the Swedish intensive care registry with the ICD 10 diagnosis U07.1 before 31 July 2020. ICU group.
- or Admitted to hospital but not ICU with the ICD-10 diagnosis U07.1 in the national patient registry before 31 July 2020. Hospital group.
- or randomly selected from the general population (and not included in the ICU or hospital admitted cohorts), matched on age, legal gender and region (four per ICU patient). Population control group
Key exclusion criteria (1 listed)
- Death within one year of inclusion. (For analysis of the secondary outcome). Missing a Swedish personal identification number
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 |
|---|---|---|
| No interventionObservational study. No intervention. | Other | COVID-19 ICU cohort, COVID-19 hospital admission control cohort, General population control cohort |
Primary outcome
Is group an independent risk factor for having one or more additional sick leave free days alive? Ordinal logistic model including variables below.
Time frame: One year
Variables in binary logistic model: On sick leave one year before ICU admission, Charlson comorbidity index, age, legal gender, highest education, immigrant background, income the year before inclusion, marital status, group (ICU, Hospital or General population).
1 secondary outcome
Is cohort an independent risk factor for being on sick leave one year after inclusion? Binary logistic model containing the variables below?
Time frame: One year
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 5 Dec 2022.
- Derived from this study: PubMed 40356220Ahlstrom B, Frithiof R, Marks-Hultstrom M, Larsson IM, Strandberg G, Lipcsey M. The 1-Year Functional Recovery From Severe COVID-19 in a Swedish Working-Age Cohort. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70058. doi: 10.1111/aas.70058.
- Individual participant dataSharing planned: No. IPD sharing is not allowed under the ethical review approval.
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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.
Miklos Lipcsey, Professor principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Uppsala University at 1 site in Sweden.
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 3 inclusion and 1 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 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
Is group an independent risk factor for having one or more additional sick leave free days alive? Ordinal logistic model including variables below. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05054608, which also lists 1 linked publication.
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 5 Dec 2022.