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)

Civil Hospices of Lyon

Status: Unknown

Conditions: SARS-Cov-2; Intensive Care Unit

Treatments: Biological: Collection of blood samples in order to create a biocollection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04392401

69HCL20_0358

2020-A01079-30 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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,

Trial design

200 participants in 1 patient group

Cohort

Description:

Patients over 18 years with a confirmed diagnosis of COVID 19 hospitalized in intensive care unit

Treatment:

Biological: Collection of blood samples in order to create a biocollection