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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01079-30 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| BioMérieux | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Patients over 18 years with a confirmed diagnosis of COVID 19 hospitalized in intensive care unit |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of blood samples in order to create a biocollection | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Kinetics over time of HLA-DR expression on the surface of monocytes | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients hospitalized in intensive care unit for the management of a SARS-CoV-2 pulmonary infection confirmed by PCR diagnosis or according to the approved method at the time of inclusion.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabienne VENET | Contact | 4 72 11 97 46 | +33 | fabienne.venet@chu-lyon.fr |
| Marie GROUSSAUD | Contact | 4 72 35 71 70 | +33 | marie.groussaud@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Fabienne VENET | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pierre Wertheimer | Recruiting | Bron | 69500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38837680 | Derived | Baudemont G, Tardivon C, Monneret G, Cour M, Rimmele T, Garnier L, Yonis H, Richard JC, Coudereau R, Gossez M, Wallet F, Delignette MC, Dailler F, Buisson M, Lukaszewicz AC, Argaud L, Laouenan C, Bertrand J, Venet F; RICO study group. Joint modeling of monocyte HLA-DR expression trajectories predicts 28-day mortality in severe SARS-CoV-2 patients. CPT Pharmacometrics Syst Pharmacol. 2024 Jul;13(7):1130-1143. doi: 10.1002/psp4.13145. Epub 2024 Jun 5. | |
| 35246776 |
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one EDTA sample and one PAXGENETM sample will be collected at Day 0, Day 3, Day 7, Day 12 and Day 20 in order to analyze immune system response
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| Hôpital Gabriel Montpied | Not yet recruiting | Clermont-Ferrand | 63000 | France |
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| Centre hospitalier universitaire de Grenoble Alpes | Not yet recruiting | Grenoble | 38043 | France |
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| Hôpital Edouard Herriot | Recruiting | Lyon | 69003 | France |
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| Hôpital Edouard Herriot | Recruiting | Lyon | 69003 | France |
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| Hôpial de la Croix Rousse | Recruiting | Lyon | 69004 | France |
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| Hôpital Lyon Sud | Recruiting | Pierre-Bénite | 69310 | France |
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| CH de St Etienne | Not yet recruiting | Saint-Etienne | 42055 | France |
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| Derived |
| Bidar F, Hamada S, Gossez M, Coudereau R, Lopez J, Cazalis MA, Tardiveau C, Brengel-Pesce K, Mommert M, Buisson M, Conti F, Rimmele T, Lukaszewicz AC, Argaud L, Cour M, Monneret G, Venet F; RICO Study Group. Recombinant human interleukin-7 reverses T cell exhaustion ex vivo in critically ill COVID-19 patients. Ann Intensive Care. 2022 Mar 5;12(1):21. doi: 10.1186/s13613-022-00982-1. |