Kohort av pasienter infisert med SARS-CoV2 (COVID-19) eller mistenkt for å være (COVIDeF)
Kohort av pasienter infisert med SARS-CoV2 eller mistenkt for å være (COVID-19 i 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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Île-de-France Region
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Paris, Île-de-France Region, Frankrike, 75013
- GH Pitié-Salpêtrière / Service d'Accueil des Urgences
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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 |
|
Annen: 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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Annen: 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. |
|
Annen: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Identification of prognostic factors for progression to a severe form of COVID-19 infection
Tidsramme: 12 months
|
Research of prognostic factors which could be implicated in the progression to severe form of COVID-19 infection. |
12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Død
Tidsramme: 12 måneder
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12 måneder
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Klinisk forverring av infeksjonen
Tidsramme: 12 måneder
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12 måneder
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Utskrivelse av sykehusinnleggelse
Tidsramme: 12 måneder
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12 måneder
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Beskrivelse av kliniske manifestasjoner
Tidsramme: 12 måneder
|
12 måneder
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Beskrivelse av biologiske manifestasjoner
Tidsramme: 12 måneder
|
12 måneder
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Beskrivelse av radiologiske manifestasjoner
Tidsramme: 12 måneder
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12 måneder
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Beskrivelse av fysiologiske manifestasjoner
Tidsramme: 12 måneder
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12 måneder
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Pasientrelaterte prognostiske faktorer
Tidsramme: 12 måneder
|
12 måneder
|
|
Virusrelaterte risikofaktorer
Tidsramme: 12 måneder
|
12 måneder
|
|
Sammenligning av resultatene fra ulike diagnosetester
Tidsramme: Inntil 12 måneder
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Inntil 12 måneder
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Pierre HAUSFATER, MD, GH Pitié Salpêtrière - Charles Foix
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Luftveisinfeksjoner
- Infeksjoner
- RNA-virusinfeksjoner
- Virussykdommer
- Sykdommer i luftveiene
- Lungesykdommer
- Lungebetennelse, viral
- Lungebetennelse
- Coronavirus-infeksjoner
- Coronaviridae-infeksjoner
- Nidovirales infeksjoner
- Covid-19
- Undersøkelsesteknikker
- Prøvehåndtering
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Punkteringer
- Kirurgiske prosedyrer, operativ
- Blodprøveinnsamling
Andre studie-ID-numre
- APHP200382
- 2020-A00754-35 (Annen identifikator: ANSM)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
IPD-delingstidsramme
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Tilgangskriterier for IPD-deling
Researchers who provide a methodologically sound proposal.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
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