NCT04578197

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 18, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 2, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

1.8 years

First QC Date

September 2, 2020

Last Update Submit

October 6, 2020

Conditions

Covid19

Keywords

SARS-CoV-2intensive careneurocognitive disorderscognitive dysfunctionbiochemical and structural brain changes

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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 Outcomes (9)

  • 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

  • Blood biomarker changes of neurological impact

    Up to 3 months

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details50 women and 50 men
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Universitetssjukhuset Solna

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

COVID-19Neurocognitive DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMental DisordersCognition Disorders

Study Officials

  • Lars I Eriksson, Professor

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars I Eriksson, Professor

CONTACT

+46-8-51770000lars.i.eriksson@sll.se

Mia Kivipelto, Professor

CONTACT

miia.kivipelto@sll.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 2, 2020

First Posted

October 8, 2020

Study Start

August 18, 2020

Primary Completion

June 1, 2022

Study Completion

November 1, 2022

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

SE(1)