NeuroCovid - a Study of Intensive Care-requiring Covid-19 Patients

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04578197
• Other study ID #: Dnr 2020-02760
• Status: Recruiting
• Start date: August 18, 2020
• Est. completion date: November 2022

Study information

• Verified date: October 2020
• Source: Karolinska University Hospital
• Contact: Lars I Eriksson, Professor
• Phone: +46-8-51770000
• Email: lars.i.eriksson[@]sll.se
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Need for Intensive care

• Positive PCR test for SARS-CoV-2

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Covid19

Locations

Country	Name	City	State
Sweden	Karolinska Universitetssjukhuset Solna	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The association between changes in blood biomarkers for inflammation and the presence of neuroradiologically verified brain injury and neurocognitive disorder		Up to 12 months
Primary	The association between changes in blood biomarkers for nerve cell damage and the presence of neuroradiologically verified brain injury and neurocognitive disorder		Up to 12 months
Primary	The association between changes in blood biomarkers for neurodegeneration and the presence of neuroradiologically verified brain injury and neurocognitive disorder		Up to 12 months
Secondary	The association between changes in coagulation factors and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder		Up to 12 months
Secondary	The association between changes in coagulation ability (ROTEM analysis - rotational thromboelastometry) and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder		Up to 12 months
Secondary	The association between changes in inflammatory biomarkers and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder		Up to 12 month
Secondary	Blood biomarker changes of inflammation impact	Markers of inflammation impact - in relation to cerebrospinal fluid changes .	Up to 3 months
Secondary	Blood biomarker changes of neurological impact	Markers of neurological impact - in relation to cerebrospinal fluid changes .	Up to 3 months
Secondary	Neuroradiological changes	Neurological impact in relation to cerebrospinal fluid changes	Up to 3 months
Secondary	Clinical course - Pulmonary gas exchange	in relation to cerebrospinal fluid changes/blood	Up to 3 months
Secondary	Clinical course - Lung function recording	in relation to cerebrospinal fluid changes/blood	Up to 3 months
Secondary	Patient characteristics	Patient ICU care data - in relation to cerebrospinal fluid changes	Up to 3 months