Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-30 @ 2:09 AM
Study NCT ID:
NCT04785157
Status:
COMPLETED
Last Update Posted:
2023-08-24
First Post:
2021-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurotropism and Neuroinflammation in COVID-19 Patients With Delirium.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015415', 'term': 'Biomarkers'}, {'id': 'D000073216', 'term': 'Mental Status and Dementia Tests'}], 'ancestors': [{'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'TSPO (Translocator protein) phenotype SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF) systemic and central immune response characterization (peripheral blood and cerebrospinal fluid CSF)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-22', 'studyFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2021-03-04', 'lastUpdatePostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PET imaging examination', 'timeFrame': 'Day 0', 'description': 'Intensity and topography of \\[18F\\]DPA-714-labeled microglial activation in vivo in PET imaging examination'}, {'measure': 'PET imaging examination', 'timeFrame': 'Month 3', 'description': 'Intensity and topography of \\[18F\\]DPA-714-labeled microglial activation in vivo in PET imaging examination'}], 'secondaryOutcomes': [{'measure': 'SARS-CoV-2 quasispecies detection in acute delirium phase in blood specimen', 'timeFrame': 'Day 0', 'description': 'SARS-CoV-2 quasispecies detection in blood specimen'}, {'measure': 'SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in blood specimen', 'timeFrame': 'Month 3', 'description': 'SARS-CoV-2 quasispecies detection in blood specimen'}, {'measure': 'SARS-CoV-2 quasispecies detection in acute delirium phase in cerebrospinal fluid specimen', 'timeFrame': 'Day 0', 'description': 'SARS-CoV-2 quasispecies detection in cerebrospinal fluid specimen'}, {'measure': 'SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in cerebrospinal fluid specimen', 'timeFrame': 'Month 3', 'description': 'SARS-CoV-2 quasispecies detection in cerebrospinal fluid specimen'}, {'measure': 'multimodal MRI in acute delirium phase', 'timeFrame': 'Day 0', 'description': 'Imaging criteria: Structural-functional disconnects at the whole brain level (multimodal MRI)'}, {'measure': 'multimodal MRI 3 months after the acute delirium phase', 'timeFrame': 'month 3', 'description': 'Imaging criteria: Structural-functional disconnects at the whole brain level (multimodal MRI)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'delirium', 'microglial activation', 'SARS-CoV-2 neurotropism'], 'conditions': ['Covid19', 'Delirium', 'Post-traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'Emerging evidence indicates that SARS-CoV-2, the etiologic agent of COVID-19, can cause neurological, neuropsychological and psychiatric complications. Given the global dimensions of the current pandemic, there is to consider the possible large-scale neurocognitive impact of COVID-19. Therefore, there is an urgent need for longitudinal studies to determine the acute and chronic effects that COVID-19 may have on the Central Nervous System. These putative effects include the possibility that the CNS serves as a reservoir for the virus, and that COVID-19 triggers CNS deleterious inflammatory cascades and neurodegenerative process. The public implications of these effects are very important in the long term.', 'detailedDescription': 'The BRAINSTORM project aims at creating a proof-of-concept dataset from severe COVID-19 patients with delirium. For the first time, this longitudinal study will rely on repeated and concomitant: i) SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF), ii) systemic and central immune response characterization, associated to the assessment of CNS damage biomarkers (peripheral blood and CSF), iii) in vivo brain PET-TSPO acquisitions (Positon Emission Tomography using a radioligand that targets the Translocator Protein, which is upregulated in activated microglia), iv) structural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity), v) multi-domains neurocognitive assessment. This dataset will be made FAIR to allow open data use and to prepare future studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients from hospital', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients (male or female \\> or = 18 years)\n* COVID-19 (positive respiratory track PCR test \\< 30 days)\n* Delirium (CAM-ICU criteria)\n* informed and written consent to participate in the study by patient's surrogate.\n\nExclusion Criteria:\n\n* medical decision of withdrawal of life sustaining treatments previous to patients recruitment\n* former neurological or psychiatric disability\n* MRI or PET scan contraindication\n* pregnancy\n* hemodynamic or respiratory failure precluding patient's transport / MRI or PET scanning"}, 'identificationModule': {'nctId': 'NCT04785157', 'acronym': 'BRAINSTORM', 'briefTitle': 'Neurotropism and Neuroinflammation in COVID-19 Patients With Delirium.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'SARS-CoV-2 Neurotropism, micRoglial ActivatioN and Cytokine dySregulaTiOn in COVID-19 Patients With Delirium', 'orgStudyIdInfo': {'id': 'RC31/20/0441'}, 'secondaryIdInfos': [{'id': '2020-005827-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'severe COVID-19 patients with delirium', 'description': 'i) SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF) ii) systemic and central immune response characterization, associated to the assessment of CNS damage biomarkers (peripheral blood and CSF) iii) in vivo brain PET-TSPO acquisitions (Positon Emission Tomography using a radioligand that targets the Translocator Protein, which is upregulated in activated microglia) iv) structural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity) v) multi-domains neurocognitive assessment.', 'interventionNames': ['Biological: serology testing profiles description', 'Biological: immune response characterization', 'Other: in vivo brain PET-TSPO acquisitions', 'Other: brain MRI assessment', 'Behavioral: neurocognitive assessment']}], 'interventions': [{'name': 'serology testing profiles description', 'type': 'BIOLOGICAL', 'otherNames': ['biomarkers'], 'description': 'SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF)', 'armGroupLabels': ['severe COVID-19 patients with delirium']}, {'name': 'immune response characterization', 'type': 'BIOLOGICAL', 'description': 'systemic and central immune response characterization , associated to the assessment of CNS damage biomarkers (peripheral blood and CSF)', 'armGroupLabels': ['severe COVID-19 patients with delirium']}, {'name': 'in vivo brain PET-TSPO acquisitions', 'type': 'OTHER', 'description': 'in vivo brain PET-TSPO acquisitions (Positon Emission Tomography using a radioligand that targets the Translocator Protein, which is upregulated in activated microglia)', 'armGroupLabels': ['severe COVID-19 patients with delirium']}, {'name': 'brain MRI assessment', 'type': 'OTHER', 'description': 'structural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity)', 'armGroupLabels': ['severe COVID-19 patients with delirium']}, {'name': 'neurocognitive assessment', 'type': 'BEHAVIORAL', 'description': 'multi-domains neurocognitive assessment', 'armGroupLabels': ['severe COVID-19 patients with delirium']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'facility': 'University Hospital of Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'country': 'France', 'facility': 'CHRU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Stein SILVA, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}