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| Name | Class |
|---|---|
| Consorci Sanitari de Terrassa | OTHER |
| Universitat Politècnica de Catalunya | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-COVID patients | Adults survivors from severe COVID-19 | ||
| Controls | Healthy adult controls |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Post-COVID Group:
Inclusion Criteria:
Exclusion Criteria:
Healthy Adult Control group
Inclusion Criteria
Exclusion criteria: the same as COVID-19 survivors
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Carme Junqué, PhD | University of Barcelona | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40595626 | Derived | 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. | |
| 40008326 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Whole blood, Feces
| 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. | 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. | 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). | 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. | 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. | 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. | 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. | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 |
| 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 |
| Derived |
| Pacheco-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. |
| 36939932 | Derived | Ariza 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. |
| 36337708 | Derived | Ariza 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |