Covid19NCT04601090
Survival Rates and Longterm Outcomes After COVID-19
An observational study of Covid19 and Acute Respiratory Failure, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The study 'Survival rates and long-term outcomes for patients with COVID-19 admitted to Norwegian ICUs' is a national observational study, including patients admitted to a Norwegian ICU between March 2020 and March 2021. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Acute Respiratory Failure, Acute Respiratory Distress Syndrome
- What is being tested?
- ICU treatment
- How many people
- 860 participants
- Where
- 1 siteNorway
- Study dates
- 16 Sep 2020to 10 Jul 2022
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that have been admitted to a Norwegian ICU with confirmed COVID-19, and not reserved them against the national register, will be contacted for inclusion to the study.
Who may be able to join
- Patients registered in Norwegian Intensive Care Register, that are ≥ 18 years with confirmed cases of COVID-19.
Who cannot join
- Exclusion criteria only for follow-up study: Do not understand Norwegian.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survival Rates and Long-term Outcomes for Patients With COVID-19 Admitted to Norwegian ICUs
The study 'Survival rates and long-term outcomes for patients with COVID-19 admitted to Norwegian ICUs' is a national observational study, including patients admitted to a Norwegian ICU between March 2020 and March 2021. The study will describe survival rates, clinical characteristics and health challenges experienced by survivors the first year after ICU admission caused by COVID-19 disease.
Read the detailed description
The study 'Survival rates and long-term outcomes for patients with COVID-19 admitted to Norwegian ICUS' has two different aims. The first aim is to synthesis data from a National register (Norwegian Intensive care register-NIR) on all COVID-19 patients in Norway admitted to an ICU. These results are of great public interest for many reasons. First of all, it will give us information on the severity of this novel virus, but also how the health care system has coped in treating the severe cases that was admitted to an ICU. The results will potentially be compared to other patient populations with viral pneumonia, but most interestingly to survival rates from other countries. In addition, the data will give us a description on how the distribution of severe cases of COVID-19 have been within Norway (e.g., gender, age, health regions etc.) The second aim of this study is to measure and describe health related challenges COVID-19 patients may experience during their first year from ICU admission. The health-related domains that will be investigated will capture both mental, physical and cognitive health. Knowledge from other patient population admitted to an ICU with acute respiratory failure, indicates that these are the main domains that negatively affect the activity of daily living. Physical, mental and cognitive health challenges will be investigated for the Norwegian COVID -19 population admitted to ICU, and will give important insight to the impact COVID-19 can have on survivors of severe cases, as well as the need for rehabilitation.
- Conditions
- Covid19, Acute Respiratory Failure, Acute Respiratory Distress Syndrome, Post Intensive Care Unit Syndrome, Survivorship
- Being tested
- ICU treatment
- Keywords
- ICU treatment
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU treatmentOther
This is an observational study, so all patients will undergo a variation of ICU treatment, and we will record that information (e.g., time on ventilator, time in ICU, SAPS score at admission)
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Survival rate
Time to survival
Measured: up to 30 days
Change in Functional Status
Measured by self-reporting using Lawton Instrumental activity of daily living. Higher score indicates better function, and ranges from 0-8.
Measured: 6 and 12 months after ICU admission
Secondary outcomes (3)
Change in Anxiety and Depression
Measured by self-report using Hospital Anxiety and Depression Scale (HADS). Higher score indicates higher lever of anxiety and depression, scored on separate sub scales (0-21 for each).
Measured: Measured 6 and 12 months after ICU admission
Changes in Cognitive Status
Measured by telephone interview using the Mini Montreal Cognitive Assessment, score ranges from 0-15. Higher score indicates better cognitive function.
Measured: Measured at 6 and 12 months after ICU admission
Change in Quality of Life 6 and 12 months after ICU admission
Measured by self report using (Euroqual 5 dimensions) EQ-5D. Higher score indicates worse health (range 5-15).
Measured: Measured 6 and 12 months after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start16 Sep 2020
- Primary completion30 Jun 2021
- Study completion10 Jul 2022
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 Oslo University HospitalThe 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
- 860 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Kristin Hofsø, Oslo University Hospital
- Investigators
- Kristin Hofsø, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601090
- Sponsor's protocol ID
- 135310
- Status last verified
- Jul 2022
- First submitted
- 15 Oct 2020
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laake JH, Hagen M, Aavitsland P, Buanes EA, Fjone KS, Kvale R, Olsen BF, Hofso K. COVID-19 in Norwegian ICUs 2020-2023: Patient characteristics, management, and outcomes-A nationwide prospective observational study. Acta Anaesthesiol Scand. 2025 Apr;69(4):e70027. doi: 10.1111/aas.70027.
PubMed 40114460
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Rates and Long-term Outcomes for Patients With COVID-19 Admitted to Norwegian ICUs
- ClinicalTrials.gov ID
- NCT04601090
- Acronym / sponsor ID
- 135310
- Conditions
- Covid19, Acute Respiratory Failure, Acute Respiratory Distress Syndrome, Post Intensive Care Unit Syndrome, Survivorship
- Keywords
- ICU treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 860 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 23 Oct 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 study 'Survival rates and long-term outcomes for patients with COVID-19 admitted to Norwegian ICUs' is a national observational study, including patients admitted to a Norwegian ICU between March 2020 and March 2021. The study will describe survival rates, clinical characteristics and health challenges experienced by survivors the first year after ICU admission caused by COVID-19 disease.
Detailed description
The study 'Survival rates and long-term outcomes for patients with COVID-19 admitted to Norwegian ICUS' has two different aims. The first aim is to synthesis data from a National register (Norwegian Intensive care register-NIR) on all COVID-19 patients in Norway admitted to an ICU. These results are of great public interest for many reasons. First of all, it will give us information on the severity of this novel virus, but also how the health care system has coped in treating the severe cases that was admitted to an ICU. The results will potentially be compared to other patient populations with viral pneumonia, but most interestingly to survival rates from other countries. In addition, the data will give us a description on how the distribution of severe cases of COVID-19 have been within Norway (e.g., gender, age, health regions etc.) The second aim of this study is to measure and describe health related challenges COVID-19 patients may experience during their first year from ICU admission. The health-related domains that will be investigated will capture both mental, physical and cognitive health. Knowledge from other patient population admitted to an ICU with acute respiratory failure, indicates that these are the main domains that negatively affect the activity of daily living. Physical, mental and cognitive health challenges will be investigated for the Norwegian COVID -19 population admitted to ICU, and will give important insight to the impact COVID-19 can have on survivors of severe cases, as well as the need for rehabilitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that have been admitted to a Norwegian ICU with confirmed COVID-19, and not reserved them against the national register, will be contacted for inclusion to the study.
Key inclusion criteria (1 listed)
- Patients registered in Norwegian Intensive Care Register, that are ≥ 18 years with confirmed cases of COVID-19.
Key exclusion criteria (1 listed)
- Exclusion criteria only for follow-up study: Do not understand Norwegian.
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 |
|---|---|---|
| ICU treatmentThis is an observational study, so all patients will undergo a variation of ICU treatment, and we will record that information (e.g., time on ventilator, time in ICU, SAPS score at admission) | Other | – |
Primary outcome
ICU Survival rate
Time frame: up to 30 days
Time to survival
Change in Functional Status
Time frame: 6 and 12 months after ICU admission
Measured by self-reporting using Lawton Instrumental activity of daily living. Higher score indicates better function, and ranges from 0-8.
3 secondary outcomes
Change in Anxiety and Depression
Time frame: Measured 6 and 12 months after ICU admission
Changes in Cognitive Status
Time frame: Measured at 6 and 12 months after ICU admission
Change in Quality of Life 6 and 12 months after ICU admission
Time frame: Measured 6 and 12 months after ICU admission
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 15 Jul 2022.
- Derived from this study: PubMed 40114460Laake JH, Hagen M, Aavitsland P, Buanes EA, Fjone KS, Kvale R, Olsen BF, Hofso K. COVID-19 in Norwegian ICUs 2020-2023: Patient characteristics, management, and outcomes-A nationwide prospective observational study. Acta Anaesthesiol Scand. 2025 Apr;69(4):e70027. doi: 10.1111/aas.70027.
- Individual participant dataSharing planned: No
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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.
Kristin Hofsø, PhD principal investigator
Oslo University Hospital
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 and Acute Respiratory Failure, run by Oslo University Hospital at 1 site in Norway.
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 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 15 Jul 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 Norway. 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?
ICU Survival rate (time frame: up to 30 days). The study lists 2 primary outcomes in all. 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 NCT04601090, 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 15 Jul 2022.