Neurobehavior and Brain Connectivity in Post COVID-19 Patients (NAUTILUS)

Consorci Sanitari de Terrassa

Status

Completed

Conditions

Post-COVID Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT05307575

202111-30-31-32 Fundació La Ma

Details and patient eligibility

About

COVID-19 neurological effects can generate long-term neurobehavioral dysfunction. Our main objective is to examine the impact of COVID-19 on neurobehavior and its relationship with illness severity. Besides, we aim to study structural and functional brain connectivity in a subsample of middle-aged post-COVID-19 individuals. Finally, we aim to develop predictive models of neurobehavioural evolution in post-COVID-19 based on multimodal data.

Full description

NAUTILUS is an observational, cross-sectional, and multicenter study. It will be performed at 22 public hospitals. Two groups of COVID-19 adults (Severe N=210, Moderate-mild N=210, WHO criteria) reporting cognitive complaints will compare to healthy controls (N=210). They will be assessed on neurobehavioral status. We will perform brain MRI in a subsample (N=120, 40 per group), and we will obtain potential biomarkers of neural damage (smell function, retinal blood plexuses integrity, and inflammation). Moreover, we will use machine learning-based algorithms based on demographics, previous pathologies, lifestyle, clinical data, and biomarkers to predict neurobehavioral models.

Expected results: Identify the neurobehavioral impact of post-COVID-19 individuals and the discriminative power of multimodal biomarkers in adverse outcomes. Our result would help develop clinically useful models to predict the neurobehavioral impact to develop future personalized and preventive intervention strategies.

Enrollment

630 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

PCS from SEVERE COVID-19 group

Inclusion Criteria:

Confirmed diagnosis of COVID-19 according to WHO interim with signs and symptoms of the severe disease during the acute phase
Presence of cognitive complaints after COVID-19 diagnosis
Participants have to be discharged from the hospital at least three months before inclusion
Accept to take part in the study and sign the informed consent according to the Declaration of Helsinki

Exclusion Criteria:

Participants have symptoms of delirium according to Delirium Rating Scale-revised 98
Established diagnosis before COVID-19 disease of psychiatric, neurological, neurodevelopmental disorder or systemic pathologies are known to cause cognitive deficits
Motor or sensory alterations that impede the neuropsychological examination
Participants with a metal prosthesis (for MRI studies)
Subjects suffering from claustrophobia or requiring sedation due to high anxiety (for MRI studies)

PCS from MILD COVID-19 group

Confirmed diagnosis of MILD COVID-19 according to WHO interim
Presence of cognitive complaints after COVID-19 diagnosis
Participants have to be diagnosed with COVID-19 at least three months before inclusion
Accept to take part in the study and sign the informed consent according to the Declaration of Helsinki

Exclusion Criteria:

Established diagnosis before COVID-19 disease of psychiatric, neurological, neurodevelopmental disorder or systemic pathologies are known to cause cognitive deficits
Motor or sensory alterations that impede the neuropsychological examination
Participants with a metal prosthesis (for MRI studies)
Subjects suffering from claustrophobia or requiring sedation due to high anxiety (for MRI studies)

Healthy adult CONTROL group

Inclusion Criteria: