Neurobiological Underpinnings of Neuropsychological Consequences in Long COVID

NCT06279936 | Active Not Recruiting

• 1 other identifier: B3002021000171
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To describe the standardized evaluation of the psychological and cognitive function of long COVID patients and their evolution, to compare immunological and HPA-axis related biomarkers between long COVID patients and healthy controls, to explore cross-sectional and longitudinal associations between immunological measures and long COVID symptoms. Study design: Cov-N-Psy is a longitudinal observational study. Three groups will be included from 2021 until 2023: long COVID patients with neuropsychological complaints (P), COVID-survivors without persistent complaints (Ca) and healthy volunteers without a history of COVID-19 (Cb). The total sample size is estimated on 130. Four visits are organized: at baseline, three, six and twelve months. The study is organized in three work packages (WP). WP1 includes a blood withdrawal and psychometric questionnaires and is part of every visit. WP2 includes cortisol measurement in saliva and takes place on the baseline visit for every participant and on the third visit for patients. Finally, WP3 includes a neurocognitive assessment at baseline for patients and Ca controls and on the third visit for patients.

Conditions

Long COVID

Keywords

brain fog; neuropsychological; depression; anxiety; immunological markers; cortisol

Outcome Measures

Primary Outcomes (1)

• Concentration of immunological and HPA-axis markers

  Compare the immunological profile and the cortisol awakening response (CAR) of long COVID NP patients to those of COVID-19 survivors without persistent complaints and healthy uninfected controls

  Baseline (11/2021-12/2023) - FU (01/2022-12/2024)

Secondary Outcomes (2)

• Rate of psychopathological and neurocognitive function of long COVID patients with neuropsychiatric complaints

  Baseline (11/2021-12/2023) - FU (01/2022-12/2024)

• Cross-sectional and longitudinal association between long COVID NP symptoms (BDI, HDRS, STAI, ISI, KEDS, FSS, NP battery ...) and immunological and cortisol measures (CAR, cytokines, serology, WBC, CRP, mitochondrial markers, TRYCATS, ...)

  Baseline (11/2021-12/2023) - FU (01/2022-12/2024)

Study Arms (3)

Long Covid patients

Long Covid patients with (neuro)psychological complaints

Other: Neuropsychological battery; Other: Surveys and symptom severity questionnaires; Other: Blood withdrawal; Other: Saliva swabs

Covid controls (Ca)

COVID-19 survivors without persistent complaints

Other: Neuropsychological battery; Other: Surveys and symptom severity questionnaires; Other: Blood withdrawal; Other: Saliva swabs

Non-Covid controls (Cb)

healthy uninfected controls

Other: Surveys and symptom severity questionnaires; Other: Blood withdrawal; Other: Saliva swabs

Interventions

Neuropsychological battery OTHER

COVID-19 patients with persistent complaints of cognitive disabilities (more than 4 weeks post-infection) in daily life are examined with an extensive neuropsychological test battery (see below) at the outpatient clinic of the University Psychiatric Centre in Duffel and at the University Hospital Antwerp. This battery covers a broad range of reliable and valid tests divided into six cognitive domains: attention, memory, visuospatial functions, language, executive functions and psychomotor speed/coordination. The neuropsychological examination lasts an average of 2 hours per participant. The tests are carried out by the same experienced neuropsychologist and also follow a standardized sequence. In addition to the neuropsychological assessment, two self-report scales are filled out by each patient. These scales are used to detect possible complaints of fatigue and possible cognitive problems which are experienced by the patient during daily life activities.

Covid controls (Ca); Long Covid patients

Surveys and symptom severity questionnaires OTHER

Both self-rated surveys and clinician administered questionnaires

Covid controls (Ca); Long Covid patients; Non-Covid controls (Cb)

Blood withdrawal OTHER

Blood samples will be collected in a standardized manner by venipuncture. Two blood vials will be collected and processed to perform the following analyses: * serum collection tube(s) allowing for HERV-W ENV and serological assays * plasma collection tubes for the assessment of other immune-related biomarkers (including but not limited to CRP, IL-6, IL-1b, TNF-a, IFN-g, tryptophan, kynurenine, 3-OH-kynurenine, quinolinic acid, kynurenic acid, enzymes of the kynurenine pathway).

Covid controls (Ca); Long Covid patients; Non-Covid controls (Cb)

Saliva swabs OTHER

Salivary cortisol measures will be used as functional measure of the HPA axis activity, as the unbound cortisol fraction in saliva is highly correlated to plasma cortisol. Baseline diurnal cortisol and CAR levels will be measured using saliva, collected at home with Salivette® (Sarstedt) synthetic swabs. The rationale behind the choice of home sampling, is to maximize normal circumstances and to minimize stress related to the measuring procedure.

Covid controls (Ca); Long Covid patients; Non-Covid controls (Cb)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Three participant groups will be included: 1) long COVID patients with neuropsychological complaints (P), 2) COVID-survivors without persistent complaints (Ca) and 3) healthy volunteers (Cb).

You may qualify if:

• years
• Diagnosis of long COVID
• (Neuro)psychological symptoms \>4 weeks after infection
• Infection with SARS-Cov-2 was detected with PCR (or antigen test)
• Other causes for their complaints are excluded by their GP or specialist
• Positive score on at least 2 NP domains during the screening phase
• years
• No prolonged symptoms due to SARS-CoV-2 infection within 4 weeks after infection
• No current (Neuro)psychological symptoms
• Infection with SARS-Cov-2 was detected with PCR (or antigen test)
• A positive score on maximum one domain (psychological / cognitive) is allowed in the absence of a psychiatric diagnosis (confirmed by the MINI) and when the complaint causes significant distress (which is investigated during the screening phase).
• years
• No (known) infection with SARS-CoV-2
• No current or previous (neuro)psychological symptoms

You may not qualify if:

• Participant is unable to read and understand the consent form and patient-reported outcomes, complete study-related procedures, or communicate with the study staff and informed consent cannot realistically be obtained in retrospect or with the help of a competent family member or legal representative.
• HPA subgroup
• Participant is pregnant or breastfeeding
• Participant receives hormonal replacement therapy (contraception is allowed).
• Participant is treated with cortisol \<4 weeks ago
• Neurocognitive assessment:
• IQ \< 90 (screened with Raven Standard Progressive Matrices (Short Form) (RSPM-SF) (39)
• Participant takes sedative medication
• Benzodiazepines: Larger than the equivalent of diazepam 10mg per day. Last administration \<8 hours prior to the neurocognitive tests.
• New sedative antipsychotics/antidepressants (\<4 weeks)
• Other medication from DRUID class III (\<4 weeks), last administration \<8 hours prior to the neurocognitive tests, or causing significant sedation.
• Severe substance abuse (alcohol + drugs)
• Pre-existing neurological diseases that influence cognitive functioning

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• UZA Foundation: collaborator

Study Sites (1)

SINAPS

Duffel, Antwerp, 2570, Belgium

Location

Related Links

• Related Info

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Mental Fatigue; Depression; Anxiety Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatigue; Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

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

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 28, 2024
• Study Start: November 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

BE (1)