Recombinant human interleukin-7 reverses T cell exhaustion ex vivo in critically ill COVID-19 patients.
Frank Bidar, Sarah Hamada, Morgane Gossez...
https://pubmed.ncbi.nlm.nih.gov/35246776Actively Recruiting
Age: 18Years +
All Genders
ID04392401
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
Led by Hospices Civils de Lyon · Updated on 2025-12-17
200
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hospices Civils de Lyon
Lead Sponsor
B
BioMérieux
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the immune response over time in adult patients infected with the SARS-CoV-2 virus who are hospitalized in intensive care units. The study aims to understand how the immune system reacts during severe COVID-19 cases, especially those developing acute respiratory distress syndrome (ARDS), which increases the risk of death. This non-interventional research seeks to identify new treatment strategies and develop biological markers to help guide future clinical trials for improving care in intensive care settings. Participants are adult patients diagnosed with COVID-19 and admitted to intensive care for the first time. Blood samples will be collected at admission, then on Days 3, 7, 12, and 20 during their hospital stay to create a biocollection. Clinical data from routine care will also be collected, and patients’ vital status will be checked at Days 28 and 90. Throughout the study, researchers will monitor the immune response by measuring HLA-DR expression on monocytes over an average of 20 days in intensive care. No treatments are assigned, as this is observational. The study involves careful data collection from clinical care and biological samples to better understand immune changes and their link to complications or recovery. Participants will be followed up to assess outcomes related to their illness and immune function.
CONDITIONS
Brief Title
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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Man or woman aged 18 or over
- Hospitalized in intensive care for SARS-CoV-2 pneumopathy
- First hospitalization in intensive care unit
- Positive diagnosis of SARS-CoV-2 infection by PCR or approved method from at least one respiratory sample
- Sampling feasible within the first 24 hours after admission to intensive care
- Patient or next of kin informed of the study and has not objected to participation
You will not qualify if you...
- Pregnant or lactating women
- Persons under legal protection
AI-Screening
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Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at admission to intensive care
Monitoring
Duration - Up to 20 days during intensive care stay
Participants have blood samples collected and clinical data recorded during their intensive care stay to monitor immune response.
5 visits (in-person) for blood sample collection at admission, Day 3, Day 7, Day 12, and Day 20
Long-term Monitoring
Duration - Up to 90 days after admission
Participants' vital status is assessed after intensive care discharge to monitor outcomes.
2 follow-up assessments at Day 28 and Day 90
Trial Site Locations
Total: 8 locations
1
Hôpital Pierre Wertheimer
Bron, France, 69500
Actively Recruiting
2
Hôpital Gabriel Montpied
Clermont-Ferrand, France, 63000
Not Yet Recruiting
3
Centre hospitalier universitaire de Grenoble Alpes
Grenoble, France, 38043
Not Yet Recruiting
4
Hôpital Edouard Herriot
Lyon, France, 69003
Actively Recruiting
5
Hôpital Edouard Herriot
Lyon, France, 69003
Actively Recruiting
6
Hôpial de la Croix Rousse
Lyon, France, 69004
Actively Recruiting
7
Hôpital Lyon Sud
Pierre-Bénite, France, 69310
Actively Recruiting
8
CH de St Etienne
Saint-Etienne, France, 42055
Not Yet Recruiting
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Research Team
F
Fabienne VENET
M
Marie GROUSSAUD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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