Cohorte de patients infectés par le SARS-CoV2 (COVID-19) ou suspectés de l'être (COVIDeF)
Cohorte de patients infectés par le SRAS-CoV2 ou suspectés de l'être (COVID-19 en Ile-de-France)
On 17th March 2020, 198 193 confirmed cases (7 730 in France) of COVID-19 infections and 7 854 deaths (175 in France) have been reported from 8th December 2019 in 157 countries. The rapid increase in cases on french territory has led to the transition of France to level 3 of the epidemic on 14th March 2020.
The natural history of the disease is still poorly understood, especially prognostic factors, which are crucial for the best medical care of patients in times of epidemics, when hospital capacities are under pressure.
A better knowledge of natural history, of prognostic factors, the development and validation of new diagnostic tests, the evaluation of medical care, will lead to a better medical care of patients infected with COVID-19.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The principal goal of the research is to assess the prognostic factors of the progression toward severe forms of the COVID-19 infection.
The secondary aims of the study are to contribute to answer some of the WHO research priority goals on COVID-19 infections:
- description of the natural history of the disease, its different forms, its clinical characterisation, its progression profile, the natural history of the disease linked to patient profiles
- evaluation and to comparison of different diagnostic methods, linked to the medical case
- description of the progression of the immune response during the infection and related to its outcome
- description of the replication and the excretion of the virus
- description of the progression of the biological markers during the infection and related to its outcome
- identification of the prognostic factors of the evolutive profile, especially if negative
- description of the patients care
- evaluation of the impact of the different therapeutic managements on the clinical outcome, the immune response, the viral load and the biomarkers.
- modeling of the epidemiologic impact
- identification of targets for treatment development
- analysis of cost data linked to the progression The population will include all patients infected with SARS-CoV2 ou suspected of being, who are taken care of at hospital.
The research is based on the collection of clinical and biological data from routine cares and on the biological analysis of blood samples.
The principal goal of the COVI-BIOME ancillary study is to identify gastrointestinal predictive factors for a severe form of the COVID-19 infection.
The principal goal of the COVIDOG ancillary study is to evaluate the sensibility and the specificity of canine olfactory detection for the volatile organic compounds of SARS-CoV2.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Île-de-France Region
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Paris, Île-de-France Region, France, 75013
- GH Pitié-Salpêtrière / Service d'Accueil des Urgences
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age ≥ 18
- Patient admitted in an emergency unit or hospitalized, infected with SARS-CoV2 or suspected of being (the recruitment can occured during acute episode or during a follow-up visit)
- Written informed consent or emergency procedure
- Affiliated to health insurance system
Exclusion Criteria:
- Refusal of participation
- Patient under justice protection measure except guardianship and trusteeship
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: COVID-19 negative
Patients with exclusion diagnosis for COVID-19 infection |
All arms: 1 blood sample at inclusion (T0) COVID-19 positive, severe only: 1 blood sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms, eventually, at discharge from hospital if the last blood sample was more than 3 days old, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization All arms: 1 feces sample at inclusion (T0) COVID-19 positive, severe only: 1 feces sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms and, eventually, at discharge from hospital All arms: 2 sweat samples at inclusion (T0) All arms: 1 saliva sample at inclusion (T0) COVID-19 positive, severe only: 1 saliva sample at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization All arms: 1 urine sample at inclusion (T0) COVID-19 positive, severe only: 1 urine sample at D3, at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 urine sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization |
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Autre: COVID-19 positive, not severe
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization |
All arms: 1 blood sample at inclusion (T0) COVID-19 positive, severe only: 1 blood sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms, eventually, at discharge from hospital if the last blood sample was more than 3 days old, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization All arms: 1 feces sample at inclusion (T0) COVID-19 positive, severe only: 1 feces sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms and, eventually, at discharge from hospital All arms: 2 sweat samples at inclusion (T0) All arms: 1 saliva sample at inclusion (T0) COVID-19 positive, severe only: 1 saliva sample at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization All arms: 1 urine sample at inclusion (T0) COVID-19 positive, severe only: 1 urine sample at D3, at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 urine sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization All arms except COVID-19 negative: 1 phone call 3 months after COVID-19 infection. All arms except COVID-19 negative: 1 phone call 6 months after COVID-19 infection. All arms except COVID-19 negative: 1 phone call 12 months after COVID-19 infection. |
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Autre: COVID-19 positive, severe
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization |
All arms: 1 blood sample at inclusion (T0) COVID-19 positive, severe only: 1 blood sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms, eventually, at discharge from hospital if the last blood sample was more than 3 days old, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization All arms: 1 feces sample at inclusion (T0) COVID-19 positive, severe only: 1 feces sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms and, eventually, at discharge from hospital All arms: 2 sweat samples at inclusion (T0) All arms: 1 saliva sample at inclusion (T0) COVID-19 positive, severe only: 1 saliva sample at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization All arms: 1 urine sample at inclusion (T0) COVID-19 positive, severe only: 1 urine sample at D3, at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 urine sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization All arms except COVID-19 negative: 1 phone call 3 months after COVID-19 infection. All arms except COVID-19 negative: 1 phone call 6 months after COVID-19 infection. All arms except COVID-19 negative: 1 phone call 12 months after COVID-19 infection. COVID-19 positive, severe only: 6 minutes walk test in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 6 minutes walk test at inclusion (T0) and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. |
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Autre: Follow-up after COVID-19 hospitalization
Patients previously hospitalized for COVID-19 infection but not recruited for the study can be recruited during a follow-up visit in hospital scheduled in standard care at 3 to 6 months after the hospitalization. For this arm, T0 = 3 to 6 months post-COVID-19 follow-up visit |
All arms: 1 blood sample at inclusion (T0) COVID-19 positive, severe only: 1 blood sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms, eventually, at discharge from hospital if the last blood sample was more than 3 days old, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization All arms: 1 saliva sample at inclusion (T0) COVID-19 positive, severe only: 1 saliva sample at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization All arms: 1 urine sample at inclusion (T0) COVID-19 positive, severe only: 1 urine sample at D3, at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 urine sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization All arms except COVID-19 negative: 1 phone call 3 months after COVID-19 infection. All arms except COVID-19 negative: 1 phone call 6 months after COVID-19 infection. All arms except COVID-19 negative: 1 phone call 12 months after COVID-19 infection. COVID-19 positive, severe only: 6 minutes walk test in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 6 minutes walk test at inclusion (T0) and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Identification of prognostic factors for progression to a severe form of COVID-19 infection
Délai: 12 months
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Research of prognostic factors which could be implicated in the progression to severe form of COVID-19 infection. |
12 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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La mort
Délai: 12 mois
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12 mois
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Aggravation clinique de l'infection
Délai: 12 mois
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12 mois
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Sortie d'hospitalisation
Délai: 12 mois
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12 mois
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Description des manifestations cliniques
Délai: 12 mois
|
12 mois
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Description des manifestations biologiques
Délai: 12 mois
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12 mois
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Description des manifestations radiologiques
Délai: 12 mois
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12 mois
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Description des manifestations physiologiques
Délai: 12 mois
|
12 mois
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Facteurs pronostiques liés au patient
Délai: 12 mois
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12 mois
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Facteurs de risque liés au virus
Délai: 12 mois
|
12 mois
|
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Comparaison des résultats de différents tests de diagnostic
Délai: Jusqu'à 12 mois
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Jusqu'à 12 mois
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Pierre HAUSFATER, MD, GH Pitié Salpêtrière - Charles Foix
Publications et liens utiles
Publications générales
- Matuozzo D, Talouarn E, Marchal A, Zhang P, Manry J, Seeleuthner Y, Zhang Y, Bolze A, Chaldebas M, Milisavljevic B, Gervais A, Bastard P, Asano T, Bizien L, Barzaghi F, Abolhassani H, Abou Tayoun A, Aiuti A, Alavi Darazam I, Allende LM, Alonso-Arias R, Arias AA, Aytekin G, Bergman P, Bondesan S, Bryceson YT, Bustos IG, Cabrera-Marante O, Carcel S, Carrera P, Casari G, Chaibi K, Colobran R, Condino-Neto A, Covill LE, Delmonte OM, El Zein L, Flores C, Gregersen PK, Gut M, Haerynck F, Halwani R, Hancerli S, Hammarstrom L, Hatipoglu N, Karbuz A, Keles S, Kyheng C, Leon-Lopez R, Franco JL, Mansouri D, Martinez-Picado J, Metin Akcan O, Migeotte I, Morange PE, Morelle G, Martin-Nalda A, Novelli G, Novelli A, Ozcelik T, Palabiyik F, Pan-Hammarstrom Q, de Diego RP, Planas-Serra L, Pleguezuelo DE, Prando C, Pujol A, Reyes LF, Riviere JG, Rodriguez-Gallego C, Rojas J, Rovere-Querini P, Schluter A, Shahrooei M, Sobh A, Soler-Palacin P, Tandjaoui-Lambiotte Y, Tipu I, Tresoldi C, Troya J, van de Beek D, Zatz M, Zawadzki P, Al-Muhsen SZ, Alosaimi MF, Alsohime FM, Baris-Feldman H, Butte MJ, Constantinescu SN, Cooper MA, Dalgard CL, Fellay J, Heath JR, Lau YL, Lifton RP, Maniatis T, Mogensen TH, von Bernuth H, Lermine A, Vidaud M, Boland A, Deleuze JF, Nussbaum R, Kahn-Kirby A, Mentre F, Tubiana S, Gorochov G, Tubach F, Hausfater P; COVID Human Genetic Effort; COVIDeF Study Group; French COVID Cohort Study Group; CoV-Contact Cohort; COVID-STORM Clinicians; COVID Clinicians; Orchestra Working Group; Amsterdam UMC Covid-19 Biobank; NIAID-USUHS COVID Study Group; Meyts I, Zhang SY, Puel A, Notarangelo LD, Boisson-Dupuis S, Su HC, Boisson B, Jouanguy E, Casanova JL, Zhang Q, Abel L, Cobat A. Rare predicted loss-of-function variants of type I IFN immunity genes are associated with life-threatening COVID-19. Genome Med. 2023 Apr 5;15(1):22. doi: 10.1186/s13073-023-01173-8.
- Cancella de Abreu M, Ropers J, Oueidat N, Pieroni L, Frere C, Fontenay M, Torelino K, Chauvin A, Hekimian G, Marcelin AG, Parfait B, Tubach F, Hausfater P; COVIDeF study group. Biomarkers of COVID-19 short-term worsening: a multiparameter analysis within the prospective multicenter COVIDeF cohort. Eur J Emerg Med. 2024 Dec 1;31(6):429-437. doi: 10.1097/MEJ.0000000000001175. Epub 2024 Sep 12.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Infections des voies respiratoires
- Infections
- Infections par virus à ARN
- Maladies virales
- Maladies des voies respiratoires
- Maladies pulmonaires
- Pneumonie virale
- Pneumonie
- Infections à coronavirus
- Infections à Coronaviridae
- Infections à Nidovirales
- COVID-19 [feminine]
- Techniques d'investigation
- Manipulation des échantillons
- Techniques de laboratoire clinique
- Techniques et procédures de diagnostic
- Diagnostic
- Perforation
- Procédures chirurgicales, opératoires
- Collection d'échantillons de sang
Autres numéros d'identification d'étude
- APHP200382
- 2020-A00754-35 (Autre identifiant: ANSM)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deindentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Délai de partage IPD
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Critères d'accès au partage IPD
Researchers who provide a methodologically sound proposal.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
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Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .