Clinical trial NCT04392401: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intensive Care Unit
SARS-Cov-2
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: BioMérieux
First posted: 2020-05-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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,

Primary outcomes:
measure: Kinetics over time of HLA-DR expression on the surface of monocytes
timeFrame: Along the intensive care stay, an average of 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Pierre Wertheimer
city: Clermont-Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Grenoble
country: France
facility: Centre hospitalier universitaire de Grenoble Alpes
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Lyon
country: France
facility: Hôpial de la Croix Rousse
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud
city: Saint-Étienne
country: France
facility: CH de St Etienne
Study officials:
affiliation: Hospices Civils de Lyon
name: Fabienne VENET
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.