A Two Year Longitudinal Clinical Study of Neurocognitive and Psychiatric Symptoms in Post COVID-19 Patients

NCT ID: NCT06298006

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-22

Study Completion Date

2027-06-30

Brief Summary

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The prospective, longitudinal, open observational study monitors patients with cognitive and neuropsychological symptoms after COVID-19 infection, in a longitudinal manner to see how the disease has affected their physical, psychological and cognitive function, their ability to be active, return to work, their health-related quality of life in correlation with potential diagnostic and prognostic markers.

Detailed Description

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The aim is to increase knowledge of the underlying biological processes; how biomarkers correlate with degree of symptoms, mapping their role as diagnostic markers over time (24 months).

The investigators follow up to 100 study participants with post-acute sequelae of SARS-CoV-2 infection (PASC) for 24 months, measure their physical, psychological and neurocognitive symtoms and how they change over time (three visits: baseline, 12 months, 24 months) in correlation with biomarkers in blood, cerebrospinal fluid and faeces samples as well as neuroradiological changes on MRI (baseline, 24 months).

Knowledge about the late effects of COVID-19 and its pathogenesis is still unknown. The findings of the study can therefore be used as a guidance for future actions in healthcare and, in the best case, can lead to a possible, either curative or symptom-relieving, treatment.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PASC24 study participants

Patients with residual cognitive and psychiatric symptoms after COVID-19 infection who undergo follow-up.

Follow-up

Intervention Type OTHER

Follow-up of neurocognitive and psychiatric symptoms in Post COVID patients (baseline, 12 months, 24 months) in correlation with biomarkers using MRI, fMRI, neuropsychological testing, lab samples (blood, CSF, microbiota).

Interventions

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Follow-up

Follow-up of neurocognitive and psychiatric symptoms in Post COVID patients (baseline, 12 months, 24 months) in correlation with biomarkers using MRI, fMRI, neuropsychological testing, lab samples (blood, CSF, microbiota).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* neurocognitive symptoms after lab-verified COVID-19 infection

Exclusion Criteria

* severe illness e.g cancer with a short expected survival time
* ongoing alcohol abuse
* ongoing drug abuse.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Örebro University, Sweden

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yvonne Freund-Levi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Faculty, Örebro University, Dept of Geriatrics, USÖ

Locations

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Department of Geriatrics, University Hospital Örebro

Örebro, , Sweden

Site Status

Countries

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Sweden

References

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van den Hurk W, Bergman I, Machado A, Bjermo J, Gustavsson A. Swedish Normative Data for Mindmore: A Comprehensive Cognitive Screening Battery, Both Digital and Self-Administrated. J Int Neuropsychol Soc. 2022 Feb;28(2):188-202. doi: 10.1017/S135561772100045X. Epub 2021 May 24.

Reference Type BACKGROUND
PMID: 34027854 (View on PubMed)

Related Links

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https://www.oru.se/forskning/forskningsproj/mv/pasc/

Information about the study on Örebro University's website

Other Identifiers

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275025

Identifier Type: -

Identifier Source: org_study_id

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