Intensive Care UnitRICONCT04392401
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
An observational study of Intensive Care Unit and SARS-Cov-2, run by Hospices Civils de Lyon at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit, SARS-Cov-2
- What is being tested?
- Collection of blood samples in order to create a biocollection
- How many people
- 200 participants
- Where
- 8 sitesFrance
- Study dates
- 11 May 2020to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Pregnant or lactating woman,
- Person placed under legal protection,
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
Hôpital Pierre Wertheimer
Bron, 69500
Anne-Claire LUKASZEWICZ, Pr
- Not yet recruiting
Hôpital Gabriel Montpied
Clermont-Ferrand, 63000
Bertrand SOUWEINE, Pr
- Not yet recruiting
Centre hospitalier universitaire de Grenoble Alpes
Grenoble, 38043
Carole SCHWEBEL, Pr
- Recruiting
Hôpital Edouard Herriot
Lyon, 69003
Laurent ARGAUD, Pr
- Recruiting
Hôpital Edouard Herriot
Lyon, 69003
Thomas RIMMELE, Pr
- Recruiting
Hôpial de la Croix Rousse
Lyon, 69004
Hodane YONIS, MD
- Recruiting
Hôpital Lyon Sud
Pierre-Bénite, 69310
Vincent PIRIOU, Pr
- Not yet recruiting
CH de St Etienne
Saint-Etienne, 42055
Guillaume THIERY, Pr
About this study
Official title: 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.
- Conditions
- Intensive Care Unit, SARS-Cov-2
- Being tested
- Collection of blood samples in order to create a biocollection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of blood samples in order to create a biocollectionBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Patients over 18 years with a confirmed diagnosis of COVID 19 hospitalized in intensive care unit Receives: Biological: Collection of blood samples in order to create a biocollection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Along the intensive care stay, an average of 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start11 May 2020
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux
- Responsible party
- Sponsor
- Investigators
- Fabienne VENET, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392401
- Sponsor's protocol ID
- 69HCL20_0358
- Other IDs
- 2020-A01079-30
- Acronym
- RICO
- Status last verified
- Dec 2025
- First submitted
- 13 May 2020
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38837680Bidar 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.
PubMed 35246776
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04392401
- Acronym / sponsor ID
- RICO / 69HCL20_0358
- Conditions
- Intensive Care Unit, SARS-Cov-2
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- 11 May 2020 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Biological: Collection of blood samples in order to create a biocollectionPatients over 18 years with a confirmed diagnosis of COVID 19 hospitalized in intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (2 listed)
- Pregnant or lactating woman,
- Person placed under legal protection,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of blood samples in order to create a biocollectionBlood 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. | Biological | Cohort |
Primary outcome
Kinetics over time of HLA-DR expression on the surface of monocytes
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Derived from this study: PubMed 38837680Baudemont 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.
- Derived from this study: PubMed 35246776Bidar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabienne VENET principal investigator
Hospices Civils de Lyon
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit and SARS-Cov-2, run by Hospices Civils de Lyon at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabienne VENET (4 72 11 97 46 ext. +33, fabienne.venet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinetics over time of HLA-DR expression on the surface of monocytes (time frame: Along the intensive care stay, an average of 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04392401, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.