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

SARS-Cov-2 Clinical Trial

— RICO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04392401
• Other study ID #: 69HCL20_0358
• Secondary ID: 2020-A01079-30
• Status: Recruiting
• Start date: May 11, 2020
• Est. completion date: May 2022

Study information

• Verified date: April 2022
• Source: Hospices Civils de Lyon
• Contact: Fabienne VENET
• Phone: 4 72 11 97 46
• Email: fabienne.venet[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• COVID-19
• Intensive Care Unit
• SARS-Cov-2

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Pierre Wertheimer	Bron
France	Hôpital Gabriel Montpied	Clermont-Ferrand
France	Centre hospitalier universitaire de Grenoble Alpes	Grenoble
France	Hôpial de la Croix Rousse	Lyon
France	Hôpital Edouard Herriot	Lyon
France	Hôpital Edouard Herriot	Lyon
France	Hôpital Lyon Sud	Pierre-Bénite
France	CH de St Etienne	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	BioMérieux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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