Covid19NCT04910334
Long-term Cognitive and Functional Status After COVID-19 Treatment at Danish ICUs
An observational study of Covid19, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
This study is a prospective observational cohort study of 6 and 12 months long-term outcome of Danish speaking patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- How many people
- 203 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2020to 1 Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is all Danish speaking COVID-19 patients, admitted and treated at one of the 29 Danish ICUs, and enrolled in the 'Danish ICU COVID-19 database' from March 10th and forward. Patients are 18 of age and above with a positive polymerase chain reaction (PCR) test for SARS-CoV-2 either prior to or during ICU admission
Who may be able to join
- > 18 years
- enrolled in the 'Danish ICU COVID-19 database'
Who cannot join
- non danish speaking patients
Trial locations and contacts
1 site in 1 country.
About this study
This study is a prospective observational cohort study of 6 and 12 months long-term outcome of Danish speaking patients with COVID-19.
Read the detailed description
To describe frailty, cognitive function, functional status, fatigue, mortality and the quality of life 6 and 12 months after ICU admission of the COVID-19 patients enrolled in the Danish ICU COVID-19 database. Furthermore to investigate the association between ventilator days and Clinical Frailty Score (CFS) and the MiniMoCA, respectively at 6 and 12 months after ICU admission
- Conditions
- Covid19
- Keywords
- covid-19, danish icu, long-term follow-up
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
The cognitive status at 6 and 12 months after ICU admission using the validated instrument MiniMoCA
The cognitive status at 6 and 12 months after ICU admission using the validated instrument MiniMoCA. Score 0-15, score above 11 indicate normal cognitive function. Two time points to see if there is a change in the cognitive status over time.
Measured: at 6 and 12 months after ICU admission
The functional status at 6 and 12 months after ICU admission using the validated instrument CFS
The functional status at 6 and 12 months after ICU admission using the validated instrument CFS (score 1-9) higher levels indicate more frailty. Two time points to see if there is a change in the frailty status over time.
Measured: at 6 and 12 months after ICU admission
Secondary outcomes (7)
The association between ventilator days and CFS 6 and 12 months after ICU admission
The association between ventilator days and CFS 6 and 12 months after ICU admission. Will be one analysis.
Measured: at 6 and 12 months after ICU admission
The association between ventilator days and MiniMoCA 6 and 12 months after ICU admission
The association between ventilator days and MiniMoCA 6 and 12 months after ICU admission. Will be one analysis. But need to time points to see if there is a change.
Measured: at 6 and 12 months after ICU admission
Mortality 6 and 12 months after ICU admission
Mortality 6 and 12 months after ICU admission. To see if there is a change i mortality at 6 and 12 months.
Measured: at 6 and 12 months after ICU admission
EQ-5D-5L score 6 and 12 months after ICU admission
EQ-5D-5L score 6 and 12 months after ICU admission. Score 5-25. low score indicate better quality of life. Two time points to see if there is a change.
Measured: at 6 and 12 months after ICU admission
Barthel ADL score 6 and 12 months after ICU admission
Barthel ADL score 6 and 12 months after ICU admission. Score 0-20, high score indicate high independence. Two time points to see if there is a change.
Measured: at 6 and 12 months after ICU admission
Lawton-Brody IADL score 6 and 12 months after ICU admission
Lawton-Brody IADL score 6 and 12 months after ICU admission. score from 0-8 for female and 0-5 for male. High score indicate high independence. Two time points to see if there is a change.
Measured: at 6 and 12 months after ICU admission
FAS score 6 and 12 months after ICU admission
FAS score 6 and 12 months after ICU admission. score from 10-50, high score indicate high level of fatigue. Two time points to see if there is a change.
Measured: at 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 posted2 Jun 2021
- Study start1 Oct 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Zealand 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
- 203 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lone Poulsen, MD, Study director, Department of Anaesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910334
- Sponsor's protocol ID
- REG-135-2020
- Status last verified
- Jun 2021
- First submitted
- 4 Feb 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Cognitive and Functional Status After COVID-19 Treatment at Danish ICUs
- ClinicalTrials.gov ID
- NCT04910334
- Acronym / sponsor ID
- REG-135-2020
- Conditions
- Covid19
- Keywords
- covid-19, danish icu, long-term follow-up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 203 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 2 Jun 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.
This study is a prospective observational cohort study of 6 and 12 months long-term outcome of Danish speaking patients with COVID-19.
Detailed description
To describe frailty, cognitive function, functional status, fatigue, mortality and the quality of life 6 and 12 months after ICU admission of the COVID-19 patients enrolled in the Danish ICU COVID-19 database. Furthermore to investigate the association between ventilator days and Clinical Frailty Score (CFS) and the MiniMoCA, respectively at 6 and 12 months after ICU admission
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is all Danish speaking COVID-19 patients, admitted and treated at one of the 29 Danish ICUs, and enrolled in the 'Danish ICU COVID-19 database' from March 10th and forward. Patients are 18 of age and above with a positive polymerase chain reaction (PCR) test for SARS-CoV-2 either prior to or during ICU admission
Key inclusion criteria (2 listed)
- > 18 years
- enrolled in the 'Danish ICU COVID-19 database'
Key exclusion criteria (1 listed)
- non danish speaking patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The cognitive status at 6 and 12 months after ICU admission using the validated instrument MiniMoCA
Time frame: at 6 and 12 months after ICU admission
The cognitive status at 6 and 12 months after ICU admission using the validated instrument MiniMoCA. Score 0-15, score above 11 indicate normal cognitive function. Two time points to see if there is a change in the cognitive status over time.
The functional status at 6 and 12 months after ICU admission using the validated instrument CFS
Time frame: at 6 and 12 months after ICU admission
The functional status at 6 and 12 months after ICU admission using the validated instrument CFS (score 1-9) higher levels indicate more frailty. Two time points to see if there is a change in the frailty status over time.
7 secondary outcomes
The association between ventilator days and CFS 6 and 12 months after ICU admission
Time frame: at 6 and 12 months after ICU admission
The association between ventilator days and MiniMoCA 6 and 12 months after ICU admission
Time frame: at 6 and 12 months after ICU admission
Mortality 6 and 12 months after ICU admission
Time frame: at 6 and 12 months after ICU admission
EQ-5D-5L score 6 and 12 months after ICU admission
Time frame: at 6 and 12 months after ICU admission
Barthel ADL score 6 and 12 months after ICU admission
Time frame: at 6 and 12 months after ICU admission
Lawton-Brody IADL score 6 and 12 months after ICU admission
Time frame: at 6 and 12 months after ICU admission
FAS score 6 and 12 months after ICU admission
Time frame: at 6 and 12 months after ICU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Lone Poulsen, MD study director
Department of Anaesthesiology and Intensive Care
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 Zealand University Hospital at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 2 Jun 2021. 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 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?
Results are not available in the source record.
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?
The cognitive status at 6 and 12 months after ICU admission using the validated instrument MiniMoCA (time frame: at 6 and 12 months after ICU admission). 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?
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 2 Jun 2021.