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

• Conditions: Covid19

• Registration Number: NCT04578197
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-18
• Study First Submitted: 2020-09-02
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-06
• Last Update Submitted: 2020-10-06
• Study First Posted: 2020-10-08
• Last Update Posted: 2020-10-08
• Primary Completion: 2022-06
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The association between changes in blood biomarkers for neurodegeneration and the presence of neuroradiologically verified brain injury and neurocognitive disorder	Up to 12 months
The association between changes in blood biomarkers for inflammation and the presence of neuroradiologically verified brain injury and neurocognitive disorder	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	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
Clinical course - Pulmonary gas exchange	Up to 3 months	in relation to cerebrospinal fluid changes/blood
Blood biomarker changes of neurological impact	Up to 3 months	Markers of neurological impact - in relation to cerebrospinal fluid changes .
Clinical course - Lung function recording	Up to 3 months	in relation to cerebrospinal fluid changes/blood
The association between changes in coagulation factors and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder	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	Up to 12 months
The association between changes in inflammatory biomarkers and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder	Up to 12 month
Blood biomarker changes of inflammation impact	Up to 3 months	Markers of inflammation impact - in relation to cerebrospinal fluid changes .
Neuroradiological changes	Up to 3 months	Neurological impact in relation to cerebrospinal fluid changes
Patient characteristics	Up to 3 months	Patient ICU care data - in relation to cerebrospinal fluid changes

Trial Locations

Locations (1)

Karolinska Universitetssjukhuset Solna; 🇸🇪 Stockholm, Sweden