COVID-19 and Brain: Cognition and Mental Health

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

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-14

Study Completion Date

2022-12-31

Brief Summary

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The main goal of DIANA is to investigate the potential discriminative power of multimodal biomarkers in COVID adverse outcomes. The study of the neuropathological underlying mechanisms in COVID from a translational approach at: (1) the behavioural-clinical level from cognitive, emotional and functional data; (2) the brain connectome level from structural and functional imaging data; and (3) biogenetic level from blood and stool data. Moreover, the investigators will develop machine learning based predictive models of cognitive, mental health, functionality, and brain connectivity evolution in post-COVID syndrome patients.

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Detailed Description

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DIANA project is an observational, descriptive, and cross-sectional study in which participants will not be randomized. Case people (adult survivors of severe COVID-19 N=134) will compare to healthy adult controls (n=66). It is a multicentric study where all the participants will be recruited from eleven Catalan public health institutions. The participants will be assessed on cognitive, emotional and functional status. The investigators will obtain a blood sample to study inflammation, vascular risk, growth factors, angiogenesis, neurogenesis, and cellular metabolism biomarkers and genes, and a stool sample for gut microbiota study. Structural and functional MRI will be performed on a subgroup of participants 40 COVID-19 survivors and 40 healthy controls.

The objectives of the project are:

1. To examine the impact of the COVID-19 illness on cognition, emotion/behavior, and functionality.
2. To examine the possible affectation in brain grey and white matter and functional connectivity of severe forms COVID-19 survivors.
3. To relate demographic characteristics, previous pathologies, lifestyle, baseline cerebral status, genetic polymorphism, and clinical data in acute illness with cognitive, mental health, functionality, and brain connectivity outcomes of severe forms COVID-19 survivors.
4. To study the post-COVID-19 biomarkers of inflammation, vascular risk, growth factors, angiogenesis, neurogenesis, and cellular metabolism and its relationship with the cognitive, mental health, functionality, and brain connectivity outcomes of severe forms COVID-19 survivors.
5. To quantify the presence of different bacterial species in the post COVID stool sample and analyze the wealth and diversity of the diverse populations. To study if these values are related to the performance of neuropsychological and behavioral tests and neuroimaging data.
6. \- To develop machine learning based predictive models of cognitive, mental health, functionality and brain connectivity evolution in post COVID 19 survivors.

Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Post-COVID patients

Adults survivors from severe COVID-19

No interventions assigned to this group

Controls

Healthy adult controls

No interventions assigned to this group

Eligibility Criteria

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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

* Healthy people who have not had COVID-19
* 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)

Healthy Adult Control group

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes