COVID-19DIANANCT05307549
COVID-19 and Brain: Cognition and Mental Health
An observational study of COVID-19, run by University of Barcelona at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 14 May 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: COVID-19 survivors group will be recruited in hospital and primary care services. The control population will be searched in the general population through primary care centers, the media, social networks, and they will be offered to participate in the study without remuneration.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- To examine the impact of the COVID-19 illness on cognition, emotion/behavior, and functionality.
- To examine the possible affectation in brain grey and white matter and functional connectivity of severe forms COVID-19 survivors.
- 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.
- 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.
- 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.
- - To develop machine learning based predictive models of cognitive, mental health, functionality and brain connectivity evolution in post COVID 19 survivors.
- Conditions
- COVID-19
- Keywords
- COVID-19, Cognition, Mental Health, Neuroimaging, MachineLearning
- Medical subject headings
- COVID-19, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post-COVID patients | Adults survivors from severe COVID-19 | |
| Controls | Healthy adult controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between groups in auditory attention
Auditory attention is measured with Digit Span Forward. Participants are asked to repeat numbers in the same order as read aloud by the examiner. Higher scores mean a better outcome.
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in working memory
Working memory is measured with Digit Span Backward. Participants are asked to repeat the numbers in the reverse order of that presented by the examiner. Higher scores mean a better outcome.
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in language
Language is measured with the Boston Naming Test. It consists of 60 line drawings of objects of graded difficulty, ranging from very common things to less familiar objects. The total score is the sum of correct answers. Higher scores mean a better outcome.
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in verbal memory
Verbal memory is measured with the Auditory Verbal Learning Test (AVLT). It is a word-learning test where five presentations of a 15-word list are given, each followed by an attempted recall. This is followed by a second 15-word interference list (list B), followed by recall of list A. Delayed recall and recognition are also tested. Higher scores mean a better outcome.
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in visual memory
Visual memory is measured with the Rey-Osterrieth Complex Figure (ROCF) test. The participants are asked to copy complex geometric shapes and then reproduce them from memory. A delayed recall is also tested. Higher scores mean a better outcome.
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in psychomotor speed
Processing speed is measured with Coding subtest of WAIS. Participants are asked to use a key to put in the appropriate symbols for a list of numbers. Higher scores mean a better outcome.
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in perceptual reasoning
Perceptual reasoning is measured with Matrix reasoning subtest of WAIS. Participants are asked to choose which of some possible options the missing picture is from matrix of abstract pictures. Higher scores mean a better outcome.
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in executive function
A composite score is made with the z-scores of phonemic (sum of the three letters) and semantic fluency, Trail Making Test B (time) and STROOP test (color-word interference total items in 120 seconds).
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in social cognition
Social cognition is measured with the Reading the Mind in the Eyes Test. Participants are asked to choose the emotional state that best describes the eyes, choosing between one of four possible emotions in the 36 photographs of male and female eyes depicting emotional states. Higher scores mean a better outcome.
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in anxiety
Anxiety is measured with the 7-item Generalized Anxiety Disorder Scale (GAD-7), a Likert-type scale with questions ranging from "not at all" (0 points) to "nearly every day" (3 points). The maximum score is 24. Higher scores mean a worse outcome.
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in depression
Depression is measured with the Patient Health Questionnaire-9 (PHQ-9) which scores each of the 9 DSM-IV criteria as "not at all" (0 points) to "nearly every day" (3 points). Higher scores mean a worse outcome.
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in Post-traumatic Stress Disorder
Post-Traumatic Stress Disorder is measured with The Post-Traumatic Stress Disorder Checklist (PCL-5), a 20-item questionnaire corresponding to the DSM-5 symptom criteria for PTSD, which scores each criterion as "not at all" (0 points) to "extremely" (4 points). The ratings of items are added together to calculate the total score (range=0-80). Higher scores mean a worse outcome.
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Secondary outcomes (16)
Differences between groups in Fatigue
Fatigue is measured with the Chalder Fatigue Scale, an 11-item questionnaire measuring the severity of physical and mental fatigue on two separate subscales. Seven items represent physical fatigue (items 1-7) and 4 represent mental fatigue (items 8-11). Each item " less than usual" (0) to " much more than usual" (3). The ratings of items are added together to calculate the total score (range=0-33). High scores represent high levels of fatigue.
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in Quality of Life
Quality of life is measured with a 12-item World Health Organization Disability Assessment Schedule-II (WHODAS-II). Patients are asked to state the level of difficulty experienced, considering how they usually do the activity. The scale scores each item as "none" (1) to "cannot do" (5). The total score is calculated with an SPSS syntax, and the range varies from 0 to 100, with higher scores reflecting more significant disability.
(WHODAS-II)
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in White Matter integrity
White matter integrity: tractography measured by MRI
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in brain Volumetry
Grey and white matter volume measured by MRI
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in Resting-state connectivity
Resting state brain activity using fMRI
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic Interleukin- 6 (IL-6)
The plasma levels of IL-6 are measured with enzyme-linked immunosorbent assay (ELISA) Kit
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic D-Dimer
The plasma levels of D-Dimer are measured with ELISA Kit
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic Nerve Growth Factor (NGF)
The plasma levels of NGF are measured with ELISA Kit
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic Glial Fibrillary Acidic Protein (GFAp)
The plasma levels of GFAp are measured with ELISA Kit
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic NT-proB-type Natriuretic Peptide (BNP)
The plasma levels of BNP are measured with ELISA Kit
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic lipid peroxidation products
The plasma levels of malondialdehyde are measured with TBARS assay method
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic Thrombomodulin
The plasma levels of Thrombomodulin are measured with ELISA Kit
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic Endothelin 1
The plasma levels of Endothelin 1 are measured with ELISA Kit
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic Ferritin
The plasma levels of Ferritin are measured with biochemical assay
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic C-Reactive Protein (CRP)
The plasma levels of CRP are measured with high sensitivity c-reactive protein ELISA Kit
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in Microbiota data
Bacterial composition of stool samples in terms of relative abundance
Measured: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start14 May 2021
- Primary completion30 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Consorci Sanitari de Terrassa, Universitat Politècnica de Catalunya
- Responsible party
- Principal investigator, Carme Junqué, University of Barcelona
- Investigators
- Carme Junqué, PhD, Study director, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307549
- Sponsor's protocol ID
- 2020PANDE00053
- Acronym
- DIANA
- Status last verified
- Dec 2022
- First submitted
- 22 Mar 2022
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carreras-Vidal L, Pacheco-Jaime L, Ariza M, Cano N, Garolera M, Garcia-Vicente C, Roura I, Capdevila-Lacasa C, Oltra J, Pardo J, Martin-Barcelo C, Campabadal A, Sala-Llonch R, Bargallo N, Barrue C, Bejar J, Cortes CU, Junque C; NAUTILUS-Project Collaborative Group; Segura B. Functional brain abnormalities in post COVID-19 condition and their relationship with cognition. Sci Rep. 2025 Jul 1;15(1):22259. doi: 10.1038/s41598-025-00739-3.
PubMed 40595626Pacheco-Jaime L, Garcia-Vicente C, Ariza M, Cano N, Garolera M, Carreras-Vidal L, Roura I, Capdevila-Lacasa C, Oltra J, Pardo J, Martin-Barcelo C, Campabadal A, Sala-Llonch R, Bargallo N, Barrue C, Bejar J, Cortes CU, Junque C, Segura B; NAUTILUS-Project Collaborative Group. Structural brain changes in post-COVID condition and its relationship with cognitive impairment. Brain Commun. 2025 Feb 12;7(1):fcaf070. doi: 10.1093/braincomms/fcaf070. eCollection 2025.
PubMed 40008326Ariza M, Cano N, Segura B, Adan A, Bargallo N, Caldu X, Campabadal A, Jurado MA, Mataro M, Pueyo R, Sala-Llonch R, Barrue C, Bejar J, Cortes CU; NAUTILUS Project Collaborative Group; Garolera M, Junque C. COVID-19 severity is related to poor executive function in people with post-COVID conditions. J Neurol. 2023 May;270(5):2392-2408. doi: 10.1007/s00415-023-11587-4. Epub 2023 Mar 20.
PubMed 36939932Ariza M, Cano N, Segura B, Adan A, Bargallo N, Caldu X, Campabadal A, Jurado MA, Mataro M, Pueyo R, Sala-Llonch R, Barrue C, Bejar J, Cortes CU; NAUTILUS-Project Collaborative Group; Junque C, Garolera M. Neuropsychological impairment in post-COVID condition individuals with and without cognitive complaints. Front Aging Neurosci. 2022 Oct 20;14:1029842. doi: 10.3389/fnagi.2022.1029842. eCollection 2022.
PubMed 36337708
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 and Brain: Cognition and Mental Health
- ClinicalTrials.gov ID
- NCT05307549
- Acronym / sponsor ID
- DIANA / 2020PANDE00053
- Conditions
- COVID-19
- Keywords
- COVID-19, Cognition, Mental Health, Neuroimaging, MachineLearning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Consorci Sanitari de Terrassa, Universitat Politècnica de Catalunya
- Study start
- 14 May 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To examine the impact of the COVID-19 illness on cognition, emotion/behavior, and functionality.
- To examine the possible affectation in brain grey and white matter and functional connectivity of severe forms COVID-19 survivors.
- 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.
- 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.
- 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.
- - To develop machine learning based predictive models of cognitive, mental health, functionality and brain connectivity evolution in post COVID 19 survivors.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-COVID patients | – | –Adults survivors from severe COVID-19 |
| Controls | – | –Healthy adult controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 survivors group will be recruited in hospital and primary care services. The control population will be searched in the general population through primary care centers, the media, social networks, and they will be offered to participate in the study without remuneration.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences between groups in auditory attention
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Auditory attention is measured with Digit Span Forward. Participants are asked to repeat numbers in the same order as read aloud by the examiner. Higher scores mean a better outcome.
Differences between groups in working memory
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Working memory is measured with Digit Span Backward. Participants are asked to repeat the numbers in the reverse order of that presented by the examiner. Higher scores mean a better outcome.
Differences between groups in language
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Language is measured with the Boston Naming Test. It consists of 60 line drawings of objects of graded difficulty, ranging from very common things to less familiar objects. The total score is the sum of correct answers. Higher scores mean a better outcome.
Differences between groups in verbal memory
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Verbal memory is measured with the Auditory Verbal Learning Test (AVLT). It is a word-learning test where five presentations of a 15-word list are given, each followed by an attempted recall. This is followed by a second 15-word interference list (list B), followed by recall of list A. Delayed recall and recognition are also tested. Higher scores mean a better outcome.
Differences between groups in visual memory
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Visual memory is measured with the Rey-Osterrieth Complex Figure (ROCF) test. The participants are asked to copy complex geometric shapes and then reproduce them from memory. A delayed recall is also tested. Higher scores mean a better outcome.
Differences between groups in psychomotor speed
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Processing speed is measured with Coding subtest of WAIS. Participants are asked to use a key to put in the appropriate symbols for a list of numbers. Higher scores mean a better outcome.
Differences between groups in perceptual reasoning
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Perceptual reasoning is measured with Matrix reasoning subtest of WAIS. Participants are asked to choose which of some possible options the missing picture is from matrix of abstract pictures. Higher scores mean a better outcome.
Differences between groups in executive function
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
A composite score is made with the z-scores of phonemic (sum of the three letters) and semantic fluency, Trail Making Test B (time) and STROOP test (color-word interference total items in 120 seconds).
Differences between groups in social cognition
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Social cognition is measured with the Reading the Mind in the Eyes Test. Participants are asked to choose the emotional state that best describes the eyes, choosing between one of four possible emotions in the 36 photographs of male and female eyes depicting emotional states. Higher scores mean a better outcome.
Differences between groups in anxiety
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Anxiety is measured with the 7-item Generalized Anxiety Disorder Scale (GAD-7), a Likert-type scale with questions ranging from "not at all" (0 points) to "nearly every day" (3 points). The maximum score is 24. Higher scores mean a worse outcome.
Differences between groups in depression
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Depression is measured with the Patient Health Questionnaire-9 (PHQ-9) which scores each of the 9 DSM-IV criteria as "not at all" (0 points) to "nearly every day" (3 points). Higher scores mean a worse outcome.
Differences between groups in Post-traumatic Stress Disorder
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Post-Traumatic Stress Disorder is measured with The Post-Traumatic Stress Disorder Checklist (PCL-5), a 20-item questionnaire corresponding to the DSM-5 symptom criteria for PTSD, which scores each criterion as "not at all" (0 points) to "extremely" (4 points). The ratings of items are added together to calculate the total score (range=0-80). Higher scores mean a worse outcome.
16 secondary outcomes
Differences between groups in Fatigue
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in Quality of Life
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in White Matter integrity
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in brain Volumetry
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in Resting-state connectivity
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic Interleukin- 6 (IL-6)
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic D-Dimer
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic Nerve Growth Factor (NGF)
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic Glial Fibrillary Acidic Protein (GFAp)
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic NT-proB-type Natriuretic Peptide (BNP)
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic lipid peroxidation products
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic Thrombomodulin
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic Endothelin 1
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic Ferritin
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in plasmatic C-Reactive Protein (CRP)
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Differences between groups in Microbiota data
Time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Derived from this study: PubMed 40595626Carreras-Vidal L, Pacheco-Jaime L, Ariza M, Cano N, Garolera M, Garcia-Vicente C, Roura I, Capdevila-Lacasa C, Oltra J, Pardo J, Martin-Barcelo C, Campabadal A, Sala-Llonch R, Bargallo N, Barrue C, Bejar J, Cortes CU, Junque C; NAUTILUS-Project Collaborative Group; Segura B. Functional brain abnormalities in post COVID-19 condition and their relationship with cognition. Sci Rep. 2025 Jul 1;15(1):22259. doi: 10.1038/s41598-025-00739-3.
- Derived from this study: PubMed 40008326Pacheco-Jaime L, Garcia-Vicente C, Ariza M, Cano N, Garolera M, Carreras-Vidal L, Roura I, Capdevila-Lacasa C, Oltra J, Pardo J, Martin-Barcelo C, Campabadal A, Sala-Llonch R, Bargallo N, Barrue C, Bejar J, Cortes CU, Junque C, Segura B; NAUTILUS-Project Collaborative Group. Structural brain changes in post-COVID condition and its relationship with cognitive impairment. Brain Commun. 2025 Feb 12;7(1):fcaf070. doi: 10.1093/braincomms/fcaf070. eCollection 2025.
- Derived from this study: PubMed 36939932Ariza M, Cano N, Segura B, Adan A, Bargallo N, Caldu X, Campabadal A, Jurado MA, Mataro M, Pueyo R, Sala-Llonch R, Barrue C, Bejar J, Cortes CU; NAUTILUS Project Collaborative Group; Garolera M, Junque C. COVID-19 severity is related to poor executive function in people with post-COVID conditions. J Neurol. 2023 May;270(5):2392-2408. doi: 10.1007/s00415-023-11587-4. Epub 2023 Mar 20.
- Derived from this study: PubMed 36337708Ariza M, Cano N, Segura B, Adan A, Bargallo N, Caldu X, Campabadal A, Jurado MA, Mataro M, Pueyo R, Sala-Llonch R, Barrue C, Bejar J, Cortes CU; NAUTILUS-Project Collaborative Group; Junque C, Garolera M. Neuropsychological impairment in post-COVID condition individuals with and without cognitive complaints. Front Aging Neurosci. 2022 Oct 20;14:1029842. doi: 10.3389/fnagi.2022.1029842. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carme Junqué, PhD study director
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences between groups in auditory attention (time frame: At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05307549, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.