E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
young subjects with sequential psycho-cognitive disorders in the aftermath of severe COVID-19
|
sujets jeunes présentant des troubles psycho-cognitifs séquellaires dans les suites d’une COVID-19 grave |
|
E.1.1.1 | Medical condition in easily understood language |
young subjects with psycho-cognitive disorders in the aftermath of severe COVID-19
|
sujets jeunes présentant des troubles psycho-cognitifs dans les suites d’une COVID-19 grave |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084547 |
E.1.2 | Term | Exposure to COVID-19 |
E.1.2 | System Organ Class | 100000004863 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057668 |
E.1.2 | Term | Cognitive disorder |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To characterize the changes in brain metabolism observed in 18F-FDG PET-CT in the patient population included in the Neurocog-Covid study at the Nancy CHRU, compared to the brain metabolism of a control subject base. |
Caractériser les modifications du métabolisme cérébral observées en TEP-TDM au 18F-FDG, dans la population de patients inclus dans l’étude Neurocog-Covid au CHRU de Nancy, en comparaison au métabolisme cérébral d’une base de sujets contrôles. |
|
E.2.2 | Secondary objectives of the trial |
1) To compare the sensitivity of detection of abnormalities in cerebral MRI and PET-CT to 18F-FDG in the patient population included in the Neurocog-Covid study at the Nancy University Hospital. 2) To correlate the brain functions impacted and objectified on the neuropsychological assessment (BNP) to the brain metabolism observed in 18F-FDG PET-CT in the patient population included in the Neurocog-Covid study at the Nancy University Hospital. 3) Correlating brain metabolism to the volume of damage to the lung sequelae of Covid-19.
|
1) Comparer la sensibilité de détection d’anomalies en IRM cérébrale et en TEP-TDM au 18F-FDG, dans la population de patients inclus dans l’étude Neurocog-Covid au CHRU de Nancy. 2) Corréler les fonctions cérébrales impactées et objectivées sur le bilan neuropsychologique (BNP) au métabolisme cérébral observé en TEP-TDM au 18F-FDG dans la population de patients inclus dans l’étude Neurocog-Covid au CHRU de Nancy. 3) Corréler le métabolisme cérébral au volume d’atteinte des lésions pulmonaires séquellaires de la Covid-19.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patient included in the Neurocog-Covid study (i.e. presenting a cognitive disorder that has been objectified on the neuropsychological assessment and having to undergo a cerebral MRI), - Major patient who has received full information about the organization of the research and has given written informed consent (or a third person, independent of the investigator and the sponsor, in the event of a reading or writing disability), - Patient affiliated to or beneficiary of a social security plan
|
• Patient inclus dans l’étude Neurocog-Covid (c’est-à-dire présentant un trouble cognitif objectivé sur le bilan neuropsychologique et devant passer une IRM cérébrale), • Patient majeure ayant reçu l’information complète sur l’organisation de la recherche et ayant donné son consentement éclairé sous forme écrite (ou une tierce personne, indépendante de l’investigateur et du promoteur, en cas d’incapacité de lecture ou d’écriture), • Patient affilié à un régime de sécurité sociale ou bénéficiaire d’un tel régime
|
|
E.4 | Principal exclusion criteria |
- Contraindication for performing 18F-FDG PET-CT - Presence of pre-Covid-19 chronic neurological or psychiatric pathologies - Women of childbearing age who do not have effective contraception. - Pregnant woman or nursing mother. - Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code. - Persons deprived of liberty by a judicial or administrative decision, persons undergoing psychiatric care pursuant to articles L. 3212-1 and L. 3213-1 - Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code. |
• Contre-indication pour réaliser la TEP-TDM au 18F-FDG • Présence de pathologies neurologiques ou psychiatriques chroniques pré-Covid-19 • Femme en âge de procréer ne disposant pas de moyen de contraception efficace. • Femme enceinte ou mère allaitante. • Personne visée aux articles L. 1121-5, L. 1121-7 et L1121-8 du code de la santé publique. • Les personnes privées de liberté par une décision judiciaire ou administrative, les personnes faisant l'objet de soins psychiatriques en vertu des articles L. 3212-1 et L. 3213-1 • Personnes visées aux articles L. 1121-5, L. 1121-7 et L1121-8 du Code de la Santé Publique.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Volumes and topographies of brain regions (PMS-type quantitative analysis), defined as those presenting a decrease in glycolytic metabolism in 18F-FDG PET-CT in patients included in the Neurocog-Covid study at the Nancy University Hospital, compared to the control subjects.
|
Volumes et topographies des régions cérébrales (analyse quantitative type SPM), définies comme celles présentant une diminution du métabolisme glycolytique en TEP-TDM au 18F-FDG chez les patients inclus dans l’étude Neurocog-Covid au CHRU de Nancy, en comparaison à la base de sujets contrôles |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
at the end of the inlcusion |
à la fin des inclusions |
|
E.5.2 | Secondary end point(s) |
1) Number of abnormal 18F-FDG MRI and PET-CT scans in the patient population included in the Neurocog-Covid study at Nancy University Hospital.
2) Volumes and topographies of brain regions (PMS-type quantitative analysis), defined as those presenting a decrease in glycolytic metabolism in 18F-FDG PET-CT in relation to cognitive profiles identified as defective.
3) Volumes of brain regions (PMS type quantitative analysis), defined as those showing a decrease in glycolytic metabolism in 18F-FDG PET-CT in relation to the volumes of lung damage, objectively measured in 18F-FDG PET-CT. |
1) Nombre d’examens IRM et TEP-TDM au 18F-FDG anormaux dans la population de patients inclus dans l’étude Neurocog-Covid au CHRU de Nancy.
2) Volumes et topographies des régions cérébrales (analyse quantitative type SPM), définies comme celles présentant une diminution du métabolisme glycolytique en TEP-TDM au 18F-FDG en lien avec les profils cognitifs identifiés comme défaillants.
3) Volumes des régions cérébrales (analyse quantitative type SPM), définies comme celles présentant une diminution du métabolisme glycolytique en TEP-TDM au 18F-FDG en lien avec les volumes d’atteinte pulmonaire, objectivés en TEP-TDM au 18F-FDG.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
at the end of the inclusion |
à la fin des inclusions |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |