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
NCT ID: NCT04392401
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2020-05-11
2026-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort
Patients over 18 years with a confirmed diagnosis of COVID 19 hospitalized in intensive care unit
Collection of blood samples in order to create a biocollection
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.
Interventions
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Collection of blood samples in order to create a biocollection
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.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
2. Person placed under legal protection,
18 Years
ALL
No
Sponsors
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BioMérieux
INDUSTRY
Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Fabienne VENET
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Hôpital Pierre Wertheimer
Bron, , France
Hôpital Gabriel Montpied
Clermont-Ferrand, , France
Centre hospitalier universitaire de Grenoble Alpes
Grenoble, , France
Hôpital Edouard Herriot
Lyon, , France
Hôpital Edouard Herriot
Lyon, , France
Hôpial de la Croix Rousse
Lyon, , France
Hôpital Lyon Sud
Pierre-Bénite, , France
CH de St Etienne
Saint-Etienne, , France
Countries
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Central Contacts
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Facility Contacts
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Anne-Claire LUKASZEWICZ, Pr
Role: primary
Bertrand SOUWEINE, Pr
Role: primary
Carole SCHWEBEL, Pr
Role: primary
Laurent ARGAUD, Pr
Role: primary
Thomas RIMMELE, Pr
Role: primary
Hodane YONIS, MD
Role: primary
Vincent PIRIOU, Pr
Role: primary
Guillaume THIERY, Pr
Role: primary
References
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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.
Other Identifiers
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2020-A01079-30
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL20_0358
Identifier Type: -
Identifier Source: org_study_id