Informations générales (source: ClinicalTrials.gov)

NCT04392401 Statut inconnu
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)
Observational
Hospices Civils de Lyon (Voir sur ClinicalTrials)
mai 2020
mai 2022
29 juin 2024
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.
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre hospitalier universitaire de Grenoble Alpes - 38043 - Grenoble - France Carole SCHWEBEL, Pr Recrutement non commencé Contact (sur clinicalTrials)
CH de St Etienne - 42055 - Saint-Étienne - France Guillaume THIERY, Pr Recrutement non commencé Contact (sur clinicalTrials)
Hôpial de la Croix Rousse - 69004 - Lyon - France Hodane YONIS, MD En recrutement Contact (sur clinicalTrials)
Hôpital Gabriel Montpied - 63000 - Clermont-Ferrand - France Bertrand SOUWEINE, Pr Recrutement non commencé Contact (sur clinicalTrials)
Hôpital Lyon Sud - 69310 - Pierre-Bénite - France Vincent PIRIOU, Pr En recrutement Contact (sur clinicalTrials)
Hôpital Pierre Wertheimer - 69500 - Bron - France Anne-Claire LUKASZEWICZ, Pr En recrutement Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Hôpital Edouard Herriot - 69003 - Lyon - France Thomas RIMMELE, Pr En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

1. Man or woman aged 18 or over,

2. Hospitalization in intensive care for Sars-Cov-2 pneumopathy,

3. First hospitalization in intensive care unit,

4. Positive diagnosis of SARS-CoV2 infection carried out by PCR or by another approved
method in at least one respiratory sample,

5. Sampling in the first 24 hours after admission to intensive care unit (D0 / D1)
feasible,

6. Patient or next of kin who has been informed of the terms of the study and has not
objected to participating.


1. Pregnant or lactating woman,

2. Person placed under legal protection,