Understanding the immune response in COVID-19 patients in intensive care
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 Lyon · NCT04392401
This study looks at how the immune system reacts in adults with severe COVID-19 who are in intensive care to help improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Locations | 8 sites (Bron and 7 other locations) |
| Trial ID | NCT04392401 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the immune response kinetics in adult patients hospitalized in intensive care due to SARS-CoV-2 infection. By collecting blood samples within the first 24 hours of ICU admission, researchers will create a biocollection to better understand the inflammatory response and potential immunosuppression associated with COVID-19. The study seeks to fill the knowledge gap regarding the immune dynamics of critically ill COVID-19 patients, which could inform future treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over who are hospitalized in intensive care for SARS-CoV-2 pneumonia.
Not a fit: Patients who are pregnant, lactating, or under legal protection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of immune responses in COVID-19 patients, potentially guiding better treatment protocols.
How similar studies have performed: While there have been studies on COVID-19 immune responses, this specific approach of detailed kinetic analysis in ICU settings is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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,
Where this trial is running
Bron and 7 other locations
- Hôpital Pierre Wertheimer — Bron, France (RECRUITING)
- Hôpital Gabriel Montpied — Clermont-Ferrand, France (NOT_YET_RECRUITING)
- Centre hospitalier universitaire de Grenoble Alpes — Grenoble, France (NOT_YET_RECRUITING)
- Hôpital Edouard Herriot — Lyon, France (RECRUITING)
- Hôpital Edouard Herriot — Lyon, France (RECRUITING)
- Hôpial de la Croix Rousse — Lyon, France (RECRUITING)
- Hôpital Lyon Sud — Pierre-Bénite, France (RECRUITING)
- CH de St Etienne — Saint-Etienne, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Fabienne VENET — Hospices Civils de Lyon
- Study coordinator: Fabienne VENET
- Email: fabienne.venet@chu-lyon.fr
- Phone: 4 72 11 97 46
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intensive Care Unit, SARS-Cov-2