Clinical trial NCT04578197: NeuroCovid - a Study of Intensive Care-requiring Covid-19 Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: SARS-CoV-2
intensive care
neurocognitive disorders
cognitive dysfunction
biochemical and structural brain changes
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2020-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Need for Intensive care
* Positive PCR test for SARS-CoV-2

Exclusion Criteria:

* None

Primary outcomes:
measure: The association between changes in blood biomarkers for inflammation and the presence of neuroradiologically verified brain injury and neurocognitive disorder
timeFrame: Up to 12 months
measure: The association between changes in blood biomarkers for nerve cell damage and the presence of neuroradiologically verified brain injury and neurocognitive disorder
timeFrame: Up to 12 months
measure: The association between changes in blood biomarkers for neurodegeneration and the presence of neuroradiologically verified brain injury and neurocognitive disorder
timeFrame: Up to 12 months
Secondary outcomes:
measure: The association between changes in coagulation factors and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder
timeFrame: Up to 12 months
measure: The association between changes in coagulation ability (ROTEM analysis - rotational thromboelastometry) and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder
timeFrame: Up to 12 months
measure: The association between changes in inflammatory biomarkers and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder
timeFrame: Up to 12 month
measure: Blood biomarker changes of inflammation impact
timeFrame: Up to 3 months
measure: Blood biomarker changes of neurological impact
timeFrame: Up to 3 months
measure: Neuroradiological changes
timeFrame: Up to 3 months
measure: Clinical course - Pulmonary gas exchange
timeFrame: Up to 3 months
measure: Clinical course - Lung function recording
timeFrame: Up to 3 months
measure: Patient characteristics
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
Study officials:
affiliation: Karolinska University Hospital
name: Lars I Eriksson, Professor
role: PRINCIPAL_INVESTIGATOR
References: