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

Recruiting

• Conditions: SARS-Cov-2; Intensive Care Unit
• Interventions: Biological: Collection of blood samples in order to create a biocollection

• Registration Number: NCT04392401
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-11
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-03
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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,

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	Collection of blood samples in order to create a biocollection	Patients over 18 years with a confirmed diagnosis of COVID 19 hospitalized in intensive care unit

Primary Outcome Measures

Name	Time	Method
Kinetics over time of HLA-DR expression on the surface of monocytes	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

Trial Locations

Locations (7)

Hôpital Pierre Wertheimer; 🇫🇷 Bron, France

Hôpital Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Centre hospitalier universitaire de Grenoble Alpes; 🇫🇷 Grenoble, France

CH de St Etienne; 🇫🇷 Saint-Étienne, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Hôpial de la Croix Rousse; 🇫🇷 Lyon, France

Hôpital Lyon Sud; 🇫🇷 Pierre-Bénite, France