Clinical trial NCT06298006: A Two Year Longitudinal Clinical Study of Neurocognitive and Psychiatric Symptoms in Post COVID-19 Patients
Official title: Uppföljning av Psykiatriska, Kognitiva Och Neurologiska Symtom Hos Post COVID-19 Patienter.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Keywords: COVID-19 sequelae
cognitive symptoms
neuropsychological symptoms
neuropsychological testing
biomarkers
cerebrospinal fluid
microbiota
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Örebro University, Sweden
name: Karolinska Institutet
name: Karolinska University Hospital
name: Sahlgrenska University Hospital
First posted: 2024-03-07
Enrollment: 57
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: The patients:

* who have been referred for neurocognitive symptoms after Covid-19 infection to secondary health care at Örebro University Hospital (USÖ) or who themselves sought assessment at USÖ
* who meet inclusion criteria and do not meet exclusion criteria
* who agreed to study participation with a written informed consent.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in cognitive functions measured with Mindmore and change in cognitive profile in Mindmore.
timeFrame: baseline, 12 months, 24 months
measure: Symptom improvement in depression
timeFrame: baseline, 12 months, 24 months
measure: Self-reported symptom improvement in depression
timeFrame: baseline, 12 months, 24 months
measure: Grade of self-reported mental fatigue
timeFrame: baseline, 12 months, 24 months
measure: Rate of self-reported symptoms suggestive of post-traumatic stress disorder (PTSD)
timeFrame: baseline, 12 months, 24 months
measure: Grade of self-reported stress
timeFrame: baseline, 12 months, 24 months
measure: Grade of self-reported cognitive failures in everyday life
timeFrame: baseline, 12 months, 24 months
Secondary outcomes:
measure: Occurence of activity limitations and changes in health-related quality of life (QoL)
timeFrame: baseline, 12 months, 24 months
measure: Grade of work incapacity/sick leave and time to return to work
timeFrame: baseline, 12 months, 24 months
measure: Changes in body size
timeFrame: baseline, 12 months, 24 months
measure: Waist size
timeFrame: baseline, 12 months, 24 months
measure: Rate of peak expiratory flow (PEF)
timeFrame: baseline, 12 months, 24 months
measure: Grade of physical exercise capacity
timeFrame: baseline, 12 months, 24 months
measure: Concetration of Beta-Amyloid 42 in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration.
timeFrame: baseline, 24 months
measure: Beta Amyloid Ratio 42/40 in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration linked to Alzheimer's disease
timeFrame: baseline, 24 months
measure: Concentration of neurogranin in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration linked to Alzheimer's disease
timeFrame: baseline, 24 months
measure: Concentration of Tau (P-Tau) protein in cerebrospinal fluid (CSF) as a CSF biomarker of cortikal damage/neurodegeneration
timeFrame: baseline, 24 months
measure: Concentration of phosphorylated Tau (P-Tau) in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration/taupathy
timeFrame: baseline, 24 months
measure: Concentration of neurofilament light (NFL) in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration
timeFrame: baseline, 24 months
measure: Concentration of neurofilament light (NFL) in plasma as a blood biomarker of neurodegeneration
timeFrame: baseline, 24 months
measure: Occurence of APOE4 allele as biomarker of genetic predisposition to Alzheimer's disease and susceptibility to more severe course of COVID-19 infection
timeFrame: baseline
measure: Brain volumes and signal abnormalities in white and gray matter
timeFrame: baseline, 24 months
measure: Changes in functional and structural brain connectivity
timeFrame: baseline, 24 months
measure: Changes in gut microbiome
timeFrame: Baseline, 24 months
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Department of Geriatrics, University Hospital Örebro
Study officials:
affiliation: Medical Faculty, Örebro University, Dept of Geriatrics, USÖ
name: Yvonne Freund-Levi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.