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)

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.

Study Overview

• Status: Recruiting
• Conditions: Intensive Care Unit; SARS-Cov-2
• Intervention / Treatment: Biological: Collection of blood samples in order to create a biocollection

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Fabienne VENET; Phone Number: +33 4 72 11 97 46; Email: fabienne.venet@chu-lyon.fr
• Study Contact Backup: Name: Marie GROUSSAUD; Phone Number: +33 4 72 35 71 70; Email: marie.groussaud@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Hopital Pierre Wertheimer
    • Contact: Anne-Claire LUKASZEWICZ, Pr
  • Clermont-Ferrand, France, 63000
    • Not yet recruiting
    • Hôpital Gabriel Montpied
    • Contact: Bertrand SOUWEINE, Pr
  • Grenoble, France, 38043
    • Not yet recruiting
    • Centre Hospitalier Universitaire de Grenoble Alpes
    • Contact: Carole SCHWEBEL, Pr
  • Lyon, France, 69003
    • Recruiting
    • Hôpital Edouard Herriot
    • Contact: Thomas RIMMELE, Pr
  • Lyon, France, 69004
    • Recruiting
    • Hôpial de la Croix Rousse
    • Contact: Hodane YONIS, MD
  • Pierre-Bénite, France, 69310
    • Recruiting
    • Hopital Lyon Sud
    • Contact: Vincent PIRIOU, Pr
  • Saint-Étienne, France, 42055
    • Not yet recruiting
    • CH de St Etienne
    • Contact: Guillaume THIERY, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort; Patients over 18 years with a confirmed diagnosis of COVID 19 hospitalized in intensive care unit	Biological: Collection 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Along the intensive care stay, an average of 20 days

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Collaborators: BioMérieux
• Investigators: Principal Investigator: Fabienne VENET, Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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. Erratum In: Ann Intensive Care. 2022 Apr 1;12(1):30.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL20_0358; 2020-A01079-30 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No