- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04392401
COVID-19 - Study of the Kinetics of the Immune Response During the Intensive Care Unit Stay in Adult Patients Infected With SARS-CoV-2: Multicentric Non Interventional Study (RICO)
Study of the Kinetics of the Immune Response During the Intensive Care Unit Stay in Adult Patients Infected With SARS-CoV-2: Multicentric Non Interventional Study
Infection with the SARS-CoV-2 coronavirus (COVID-19) has recently been identified as a pandemic due to the speed and global scale of its transmission. In Auvergne-Rhône-Alpes region (AURA), the epidemic began in February 2020 and the number of infected people is still important. Between 15 and 20% of COVID-19 patients develop an acute respiratory distress syndrome (ARDS) leading to their hospitalization in intensive care. Their clinical progression can be rapidly harmful with the development of severe ARDS associated with an increased risk of death.
Preliminary data on the immune response of COVID-19 patients describe the induction of a moderate inflammatory response and the occurrence of major progressive lymphopenia over time associated with potential immunosuppression. Up to 50% of secondary infections are reported in deceased COVID-19 patients. However, no prospective study has exhaustively described the kinetics of the immune response of COVID-19 patients in intensive care.
The precise description of the immune response over time in adult patients with a proven infection with the SARS-CoV-2 virus and the study of the relation between this response and the increased risk of organ failure (severe ARDS), death or nosocomial infection will allow us to better understand the pathophysiology of the immune response induced by COVID-19 in order to (i) identify new therapeutic strategies targeting the host response in patients in intensive care (ii) to develop biological markers to stratify patients for future clinical trials evaluating these immunoadjuvant treatments in COVID-19.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Fabienne VENET
- Telefonnummer: +33 4 72 11 97 46
- E-post: fabienne.venet@chu-lyon.fr
Studer Kontakt Backup
- Navn: Marie GROUSSAUD
- Telefonnummer: +33 4 72 35 71 70
- E-post: marie.groussaud@chu-lyon.fr
Studiesteder
-
-
-
Bron, Frankrike, 69500
- Rekruttering
- Hopital Pierre Wertheimer
-
Ta kontakt med:
- Anne-Claire LUKASZEWICZ, Pr
-
Clermont-Ferrand, Frankrike, 63000
- Har ikke rekruttert ennå
- Hôpital Gabriel Montpied
-
Ta kontakt med:
- Bertrand SOUWEINE, Pr
-
Grenoble, Frankrike, 38043
- Har ikke rekruttert ennå
- Centre Hospitalier Universitaire de Grenoble Alpes
-
Ta kontakt med:
- Carole SCHWEBEL, Pr
-
Lyon, Frankrike, 69003
- Rekruttering
- Hopital Edouard Herriot
-
Ta kontakt med:
- Thomas RIMMELE, Pr
-
Lyon, Frankrike, 69004
- Rekruttering
- Hôpial de la Croix Rousse
-
Ta kontakt med:
- Hodane YONIS, MD
-
Pierre-Bénite, Frankrike, 69310
- Rekruttering
- Hopital Lyon Sud
-
Ta kontakt med:
- Vincent PIRIOU, Pr
-
Saint-Étienne, Frankrike, 42055
- Har ikke rekruttert ennå
- CH de St Etienne
-
Ta kontakt med:
- Guillaume THIERY, Pr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Man or woman aged 18 or over,
- Hospitalization in intensive care for Sars-Cov-2 pneumopathy,
- First hospitalization in intensive care unit,
- Positive diagnosis of SARS-CoV2 infection carried out by PCR or by another approved method in at least one respiratory sample,
- Sampling in the first 24 hours after admission to intensive care unit (D0 / D1) feasible,
- Patient or next of kin who has been informed of the terms of the study and has not objected to participating.
Exclusion Criteria:
- Pregnant or lactating woman,
- Person placed under legal protection,
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Cohort
Patients over 18 years with a confirmed diagnosis of COVID 19 hospitalized in intensive care unit
|
Blood samples will be collected at admission in intensive care, at Day 3, Day 7, Day 12 and Day 20 during their hospitalization.
Clinical data from routine care will be collected.
Vital status will be assessed at Day 28 and Day 90.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Kinetics over time of HLA-DR expression on the surface of monocytes
Tidsramme: Along the intensive care stay, an average of 20 days
|
Kinetics along the intensive care stay of HLA-DR expression on the surface of monocytes expressed as the number of antibodies fixed per cell
|
Along the intensive care stay, an average of 20 days
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Fabienne VENET, Hospices Civils de Lyon
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
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
Andre studie-ID-numre
- 69HCL20_0358
- 2020-A01079-30 (Annen identifikator: ANSM)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Intensivavdeling
-
Marlene FischerFullførtPostoperativ Quality of Recovery i Postanesthesia Care UnitTyskland
-
Yonsei UniversityFullførtICU (Intensive Care Unit) pasienter | Mekanisk ventilasjon etter operasjonKorea, Republikken
-
Associate Professor Sue Berney PhD, BPTFullførtIntensive Care Unit Acquired Weakness (ICUAW)Forente stater, Australia
-
Centre Hospitalier Universitaire de la RéunionFullførtIntensiv sportGjenforening
-
Centre Hospitalier Universitaire de la RéunionFullført
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRekrutteringCAR-T terapikomplikasjonerItalia
-
Taipei City HospitalFullførtPRU (Platelet Reactivity Unit) | APT (antiplatelet terapi) | HOTPR (High on Treat Platelet Reactivity)Taiwan
-
The Lymphoma Academic Research OrganisationNovartis; Gilead SciencesRekrutteringHematopatologi Kvalifisert eller CAR-t-cellebehandlingFrankrike
-
Mario Negri Institute for Pharmacological ResearchRekrutteringEvaluering | Kvalitet | Semi-intensiv enhetItalia
-
Massachusetts General HospitalFullførtIntensiv nevrologisk lidelseForente stater