Covid19NCT04578197
NeuroCovid - a Study of Intensive Care-requiring Covid-19 Patients
An observational study of Covid19, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Critically ill patients requiring intensive care suffer to a large extent from cognitive deficits involving higher brain functions that primarily affect memory, learning and the ability to concentrate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 18 Aug 2020to Nov 2022
- 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: Men and women with covid-19 (positive PCR test for Coronavirus SARS-CoV-2 RNA) who are admitted to the Intensive Care Unit at Karolinska University Hospital in Solna and Huddinge
Who may be able to join
- Age ≥18 years
- Need for Intensive care
- Positive PCR test for SARS-CoV-2
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Mia Kivipelto, Professor contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Universitetssjukhuset Solna
Stockholm
Lars I Eriksson, Prof, +46-8-51770000, lars.i.eriksson@sll.se
About this study
Official title: NeuroCOVID - A Study of Activation and Inhibition of the Immune and Coagulation Systems, the Presence of Biochemical (Blood / CSF) and Structural Brain Changes and Their Association With Long-term Cognitive Dysfunction in Intensive Care-requiring Covid-19 Patients
Critically ill patients requiring intensive care suffer to a large extent from cognitive deficits involving higher brain functions that primarily affect memory, learning and the ability to concentrate. While the background to this effect is not fully understood, there are growing evidence to support mechanisms related to neuro inflammation and changes in blood flow with concomitant ischemic brain damage. Patients with covid-19 often suffer from severe inflammatory activity with an increased risk of coagulation abnormalities and brain damage. Covid-19 patients requiring intensive care develope more severe impairment of neurological and cognitive function than critically ill intensive care patients who have not covid-19. This project therefore aims to map the link between inflammation, immunology and coagulation systems as well as biochemical and structural changes in the brain with cognitive effects in patients in intensive care for covid-19.
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, intensive care, neurocognitive disorders, cognitive dysfunction, biochemical and structural brain changes
- Medical subject headings
- COVID-19, Neurocognitive Disorders, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between changes in blood biomarkers for inflammation and the presence of neuroradiologically verified brain injury and neurocognitive disorder
Measured: Up to 12 months
The association between changes in blood biomarkers for nerve cell damage and the presence of neuroradiologically verified brain injury and neurocognitive disorder
Measured: Up to 12 months
The association between changes in blood biomarkers for neurodegeneration and the presence of neuroradiologically verified brain injury and neurocognitive disorder
Measured: Up to 12 months
Secondary outcomes (9)
The association between changes in coagulation factors and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder
Measured: Up to 12 months
The association between changes in coagulation ability (ROTEM analysis - rotational thromboelastometry) and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder
Measured: Up to 12 months
The association between changes in inflammatory biomarkers and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder
Measured: Up to 12 month
Blood biomarker changes of inflammation impact
Markers of inflammation impact - in relation to cerebrospinal fluid changes .
Measured: Up to 3 months
Blood biomarker changes of neurological impact
Markers of neurological impact - in relation to cerebrospinal fluid changes .
Measured: Up to 3 months
Neuroradiological changes
Neurological impact in relation to cerebrospinal fluid changes
Measured: Up to 3 months
Clinical course - Pulmonary gas exchange
in relation to cerebrospinal fluid changes/blood
Measured: Up to 3 months
Clinical course - Lung function recording
in relation to cerebrospinal fluid changes/blood
Measured: Up to 3 months
Patient characteristics
Patient ICU care data - in relation to cerebrospinal fluid changes
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start18 Aug 2020
- Primary completionJun 2022 (estimated)
- Study completionNov 2022 (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 Karolinska 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Lars I Eriksson, Karolinska University Hospital
- Investigators
- Lars I Eriksson, Professor, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578197
- Sponsor's protocol ID
- Dnr 2020-02760
- Status last verified
- Oct 2020
- First submitted
- 2 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeuroCOVID - A Study of Activation and Inhibition of the Immune and Coagulation Systems, the Presence of Biochemical (Blood / CSF) and Structural Brain Changes and Their Association With Long-term Cognitive Dysfunction in Intensive Care-requiring Covid-19 Patients
- ClinicalTrials.gov ID
- NCT04578197
- Acronym / sponsor ID
- Dnr 2020-02760
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, intensive care, neurocognitive disorders, cognitive dysfunction, biochemical and structural brain changes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 8 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.
Critically ill patients requiring intensive care suffer to a large extent from cognitive deficits involving higher brain functions that primarily affect memory, learning and the ability to concentrate. While the background to this effect is not fully understood, there are growing evidence to support mechanisms related to neuro inflammation and changes in blood flow with concomitant ischemic brain damage. Patients with covid-19 often suffer from severe inflammatory activity with an increased risk of coagulation abnormalities and brain damage. Covid-19 patients requiring intensive care develope more severe impairment of neurological and cognitive function than critically ill intensive care patients who have not covid-19. This project therefore aims to map the link between inflammation, immunology and coagulation systems as well as biochemical and structural changes in the brain with cognitive effects in patients in intensive care for covid-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women with covid-19 (positive PCR test for Coronavirus SARS-CoV-2 RNA) who are admitted to the Intensive Care Unit at Karolinska University Hospital in Solna and Huddinge
Key inclusion criteria (3 listed)
- Age ≥18 years
- Need for Intensive care
- Positive PCR test for SARS-CoV-2
Key exclusion criteria (1 listed)
- None
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 association between changes in blood biomarkers for inflammation and the presence of neuroradiologically verified brain injury and neurocognitive disorder
Time frame: Up to 12 months
The association between changes in blood biomarkers for nerve cell damage and the presence of neuroradiologically verified brain injury and neurocognitive disorder
Time frame: Up to 12 months
The association between changes in blood biomarkers for neurodegeneration and the presence of neuroradiologically verified brain injury and neurocognitive disorder
Time frame: Up to 12 months
9 secondary outcomes
The association between changes in coagulation factors and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder
Time frame: Up to 12 months
The association between changes in coagulation ability (ROTEM analysis - rotational thromboelastometry) and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder
Time frame: Up to 12 months
The association between changes in inflammatory biomarkers and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder
Time frame: Up to 12 month
Blood biomarker changes of inflammation impact
Time frame: Up to 3 months
Blood biomarker changes of neurological impact
Time frame: Up to 3 months
Neuroradiological changes
Time frame: Up to 3 months
Clinical course - Pulmonary gas exchange
Time frame: Up to 3 months
Clinical course - Lung function recording
Time frame: Up to 3 months
Patient characteristics
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
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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.
Mia Kivipelto, Professor contact
Lars I Eriksson, Professor principal investigator
Karolinska 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, run by Karolinska University Hospital 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars I Eriksson, Professor (+46-8-51770000, lars.i.eriksson@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association between changes in blood biomarkers for inflammation and the presence of neuroradiologically verified brain injury and neurocognitive disorder (time frame: Up to 12 months). The study lists 3 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 8 Oct 2020.