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
2 other identifiers
observational
200
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2020
CompletedFirst Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
May 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedDecember 17, 2025
December 1, 2025
5.9 years
May 13, 2020
December 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Cohort
Patients over 18 years with a confirmed diagnosis of COVID 19 hospitalized in intensive care unit
Interventions
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
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.
You may qualify if:
- 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.
You may not qualify if:
- Pregnant or lactating woman,
- Person placed under legal protection,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospices Civils de Lyonlead
- BioMérieuxcollaborator
Study Sites (8)
Hôpital Pierre Wertheimer
Bron, 69500, France
Hôpital Gabriel Montpied
Clermont-Ferrand, 63000, France
Centre hospitalier universitaire de Grenoble Alpes
Grenoble, 38043, France
Hôpital Edouard Herriot
Lyon, 69003, France
Hôpital Edouard Herriot
Lyon, 69003, France
Hôpial de la Croix Rousse
Lyon, 69004, France
Hôpital Lyon Sud
Pierre-Bénite, 69310, France
CH de St Etienne
Saint-Etienne, 42055, France
Related Publications (1)
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.
PMID: 35246776DERIVED
Biospecimen
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
Study Officials
- PRINCIPAL INVESTIGATOR
Fabienne VENET
Hospices Civils de Lyon
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2020
First Posted
May 18, 2020
Study Start
May 11, 2020
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
December 17, 2025
Record last verified: 2025-12