An interventional study of Blood collection on admission and longitudinally and Blood collection on their first consultation and 10 to 14 days later in COVID-19, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Basic science
The spectrum of the COVID-19 disease ranges from benign to asymptomatic to viral pneumopathy that can progress to acute respiratory distress syndrome (ARDS). The host-pathogen relationships and the physiopathological mechanisms underlying the clinical aggravation of COVID-19 patients remain misunderstood. The project aim is to create a prospective cohort of biological samples collected from well characterized COVID-19 patients. This project aims first to identify based on these samples an early immune signature predictive of clinical worsening of COVID-19 patients in order to improve their management, and secondarily to better understand pathophysiological mechanisms underlying the different phases of the disease in order to identify innovative therapeutic targets and vaccine perspectives.
The World Health Organization (WHO) has recently declared pandemic the coronavirus disease 2019 (COVID-19) due to the causative severe acute respiratory syndrome (SARS) coronavirus (CoV) 2 (SARS-CoV-2). People infected with SARS-CoV-2 vary in severity from being asymptomatic to having severe pneumonia and ARDS. Predictive markers of clinical worsening after admission are lacking. Clinical deterioration often coincides with the development of host antiviral immune responses, suggesting that the inflammatory response to SARS-CoV-2 infection may underpin COVID-19 pathogenesis leading to aberrant and excessive immune responses causing lung functional disability. Relevant therapeutic strategies are still under investigation. Based on a better understanding of COVID-19 immunopathogenesis, the identification of predictive biomarkers early in the disease process would be of outstanding interest to tailor prompt therapeutic interventions.
On this basis, the project aims to create a prospective cohort of biological samples collected from COVID-19 patients followed at the Toulouse University Hospital.
This cohort will collect and cryopreserve biological samples (33 mL), including plasma and peripheral blood mononuclear cells (PBMCs), on admission (day 0) and longitudinally (day 4, 8 12 and in discharge) and will allow us to investigate our primary and secondary objectives. This cohort will be bridged with a clinical cohort in order to have a very well-defined population of COVID-19 patients with the following outcomes:
In addition, mildly symptomatic patients among healthcare workers attending outpatient dedicated clinics will be recruited and blood samples will be collected on their first consultation and 10 to 14 days later in the frame of a medical surveillance program.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 565 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For COVID-19 hospitalized patients
For COVID-19 healthcare workers attending dedicated clinics
Exclusion Criteria:
very well-defined population of COVID-19 patients with the following outcomes: * Patients with severe disease requiring on admission ICU management for ARDS, * Non-severe hospitalized patients with secondary clinical worsening requiring ICU management, * Non-severe hospitalized patients without clinical worsening requiring ICU management.
Biological: Blood collection on admission and longitudinally
mildly symptomatic patients among healthcare workers attending outpatient dedicated clinics will be recruited
Biological: Blood collection on their first consultation and 10 to 14 days later
33 mL of blood collected on admission (day 0) and longitudinally (day 4, 8 12 and in discharge)
33 mL of blood collected on their first consultation and 10 to 14 days later
Immune signature
Analysis of the phenotypic profiling of blood T-cells by multicolor fluorescence-activated cell sorter (FACS) analysis assessing T cell subsets through the expression of a wide range of surface and intracellular markers
Time frame: Day 0
Dosage of cytokines and chemokines in plasma samples
Analysis on plasma samples of a wide range of cytokines and chemokines using multiplex
Time frame: Day 0
Immune signature
Analysis of the phenotypic profiling of blood T-cells by multicolor FACS analysis assessing T cell subsets through the expression of a wide range of surface and intracellular markers
Time frame: Day 2
Immune signature
Analysis of the phenotypic profiling of blood T-cells by multicolor FACS analysis assessing T cell subsets through the expression of a wide range of surface and intracellular markers
Time frame: Day 4
Immune signature
Analysis of the phenotypic profiling of blood T-cells by multicolor FACS analysis assessing T cell subsets through the expression of a wide range of surface and intracellular markers
Time frame: Day 8
Immune signature
Analysis of the phenotypic profiling of blood T-cells by multicolor FACS analysis assessing T cell subsets through the expression of a wide range of surface and intracellular markers
Time frame: Day 12
Immune signature
Analysis of the phenotypic profiling of blood T-cells by multicolor FACS analysis assessing T cell subsets through the expression of a wide range of surface and intracellular markers
Time frame: Day 30 (or in discharge)
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Measurement of SARS-CoV-2 specific Immunoglobulin M, Immunoglobulin G and Immunoglobulin
Time frame: Day 0
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Measurement of SARS-CoV-2 specific Immunoglobulin M, Immunoglobulin G and Immunoglobulin
Time frame: Day 2
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Measurement of SARS-CoV-2 specific Immunoglobulin M, Immunoglobulin G and Immunoglobulin
Time frame: Day 4
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Measurement of SARS-CoV-2 specific Immunoglobulin M, Immunoglobulin G and Immunoglobulin
Time frame: Day 8
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Measurement of SARS-CoV-2 specific Immunoglobulin M, Immunoglobulin G and Immunoglobulin
Time frame: Day 12
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Measurement of SARS-CoV-2 specific Immunoglobulin M, Immunoglobulin G and Immunoglobulin
Time frame: Day 30 (or in discharge)
Plan to share: No
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University Hospital, Toulouse