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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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04392401
Acronym
RICO
Enrollment
200
Registered
2020-05-18
Start date
2020-05-11
Completion date
2026-04-30
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit, SARS-Cov-2

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.

Interventions

BIOLOGICALCollection 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.

Sponsors

BioMérieux
CollaboratorINDUSTRY
Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

1. Pregnant or lactating woman, 2. Person placed under legal protection,

Design outcomes

Primary

MeasureTime frameDescription
Kinetics over time of HLA-DR expression on the surface of monocytesAlong the intensive care stay, an average of 20 daysKinetics along the intensive care stay of HLA-DR expression on the surface of monocytes expressed as the number of antibodies fixed per cell

Countries

France

Contacts

Primary ContactFabienne VENET
fabienne.venet@chu-lyon.fr4 72 11 97 46
Backup ContactMarie GROUSSAUD
marie.groussaud@chu-lyon.fr4 72 35 71 70

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026