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

NCT06298006 | Active Not Recruiting

• 1 other identifier: 275025
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19 sequelae; cognitive symptoms; neuropsychological symptoms; neuropsychological testing; biomarkers; cerebrospinal fluid; microbiota

Outcome Measures

Primary Outcomes (7)

• Change in cognitive functions measured with Mindmore and change in cognitive profile in Mindmore.

  Two digital neurocognitive test batteries (Mindmore): dementia and fatigue/depression

  baseline, 12 months, 24 months

• Symptom improvement in depression

  Montgomery Asberg Depression Rating Scale (MADRS) has has 10 items that are completed during a clinical interview.. The items of the MADRS are as follows: apparent sadness, reported sadness inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thought, suicidal thoughts. MADRS assess the severity of depression. The severity of symptoms is rated by the physician. Each item has a severity scale from 0 to 6, with higher scores reflecting more severe symptoms. Ratings can be added to form an overall score (from 0 to 60) and the higher score means a worse outcome.

  baseline, 12 months, 24 months

• Self-reported symptom improvement in depression

  Montgomery Asberg Depression Rating Scale, Self-report version (MADRS-S) has 9-items which are based on feelings over the past 3 days. The items of the MADRS-S are as follows: Mood; Feelings of unease; Sleep; Appetite; Ability to concentrate; Initiative; Emotional involvement; Pessimism; Zest for life. MADRS-S assess the severity of depression. The severity of symptoms is rated by the study participant. Each item has a severity scale from 0 to 6, with higher scores reflecting more severe symptoms. Ratings can be added to form an overall score (from 0 to 54) and the higher score means a worse outcome.

  baseline, 12 months, 24 months

• Grade of self-reported mental fatigue

  The Mental Fatigue scale (MFS) includes 14 questions that measure mental fatigue. Questions include affective, cognitive and sensory symptoms, duration of sleep and daytime variation in symptom severity. The questions concern fatigue in general, lack of initiative, mental fatigue, mental recovery, concentration difficulties, memory problems, slowness of thinking, sensitivity to stress, increased tendency to become emotional, irritability, sensitivity to light and noise, decreased or increased sleep. One additional question includes 24-hour symptom variations. The severity of symptoms is rated by the study participant. A rating of 0 corresponds to normal function and 1-3 indicating increasing problem with the symptom (No (0), Slight (1), Fairly serious (2) and Serious (3) problems). Ratings can be added to form an overall score (from 0 to 42) and the higher score means a worse outcome.

  baseline, 12 months, 24 months

• Rate of self-reported symptoms suggestive of post-traumatic stress disorder (PTSD)

  The Post-traumatic Stress Disorder Checklist for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The study partipicipant answer first a brief Criterion A för PTSD. If the answer is affirmative (i.e. PTSD is suspected) the participants continue with 20 questions (items). Each item is rated from 0 ("not at all") to 4 ("extremely") to indicate the degree to which they have been bothered by that particular symptom over the past month. Ratings can be added to form an overall score (from 0 to 80) and the higher score means a worse outcome.

  baseline, 12 months, 24 months

• Grade of self-reported stress

  Th Perceived Stress Scale (PSS-14) is a self-reported measure which assesses the degree to which the respondent has perceived situations in his/her life within the past month as stressful. The PSS-14 is comprised of 14 items intended to measure how unpredictable, uncontrollable, and overloaded individuals find their life circumstances. Individuals rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4 - "Very often." Scores range from 0-56, with higher scores indicating greater perceived stress.

  baseline, 12 months, 24 months

• Grade of self-reported cognitive failures in everyday life

  The cognitive Failures Questionnaire (CFQ) is a self-report questionnaire consisting of 25 items assessing deficits regarding attention, perception, memory and motor functioning in everyday life. The total CFQ score is calculated by summation of all answers and scores range from 0-100. A higher total score indicates more subjective cognitive failure.

  baseline, 12 months, 24 months

Secondary Outcomes (17)

• Occurence of activity limitations and changes in health-related quality of life (QoL)

  baseline, 12 months, 24 months

• Grade of work incapacity/sick leave and time to return to work

  baseline, 12 months, 24 months

• Changes in body size

  baseline, 12 months, 24 months

• Waist size

  baseline, 12 months, 24 months

• Rate of peak expiratory flow (PEF)

  baseline, 12 months, 24 months

Study Arms (1)

PASC24 study participants

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

Other: Follow-up

Interventions

Follow-up 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).

PASC24 study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• neurocognitive symptoms after lab-verified COVID-19 infection

You may not qualify if:

• severe illness e.g cancer with a short expected survival time
• ongoing alcohol abuse
• ongoing drug abuse.

Sponsors & Collaborators

• Region Örebro County: lead
• Örebro University, Sweden: collaborator
• Karolinska Institutet: collaborator
• Karolinska University Hospital: collaborator
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Department of Geriatrics, University Hospital Örebro

Örebro, Sweden

Location

Related Publications (1)

• 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.

  PMID: 34027854 BACKGROUND

Related Links

• Information about the study on Örebro University's website

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, cerebrospinal fluid (CSF), faeces

MeSH Terms

Conditions

COVID-19; Neurobehavioral Manifestations

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yvonne Freund-Levi, MD, PhD

  Medical Faculty, Örebro University, Dept of Geriatrics, USÖ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: March 7, 2024
• Study Start: February 22, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 11, 2025

Record last verified: 2025-01

Locations

SE (1)