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Clinical Trials/NCT04392401
NCT04392401
Recruiting
Not Applicable

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

Hospices Civils de Lyon7 sites in 1 country200 target enrollmentMay 11, 2020

Overview

Phase
Not Applicable
Intervention
Collection of blood samples in order to create a biocollection
Conditions
Intensive Care Unit
Sponsor
Hospices Civils de Lyon
Enrollment
200
Locations
7
Primary Endpoint
Kinetics over time of HLA-DR expression on the surface of monocytes
Status
Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 11, 2020
End Date
April 1, 2026
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Man or woman aged 18 or over,
  • Hospitalization in intensive care for Sars-Cov-2 pneumopathy,
  • First hospitalization in intensive care unit,
  • Positive diagnosis of SARS-CoV2 infection carried out by PCR or by another approved method in at least one respiratory sample,
  • Sampling in the first 24 hours after admission to intensive care unit (D0 / D1) feasible,
  • Patient or next of kin who has been informed of the terms of the study and has not objected to participating.

Exclusion Criteria

  • Pregnant or lactating woman,
  • Person placed under legal protection,

Arms & Interventions

Cohort

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

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

Outcomes

Primary Outcomes

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

Time Frame: 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

Study Sites (7)

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