An interventional study of blood sampling and additional blood tubes in New Coronavirus Disease (COVID-19), Infection With SARS-CoV-2, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 3 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-17.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Basic science
Study of the cellular immune response during the SARS-CoV-2 infection and identify cytokinic profiles in caregivers exposed to the virus with asymptomatic forms of COVID19, patients with an asymptomatic form followed in ambulatory care and patients hospitalized in the infectious disease department or in resuscitation at the CHU de Nice COVID-19 according to their clinical symptomatology and the kinetics of clinical aggravation using functional tests evaluating the Th1 type immune response.
The project is divided into a clinical component comprising the study of the immune response in different populations and a cellular component focusing on the in vitro study of different immunomodulating treatments on their ability to induce an anti-viral Th1
Since March 2020, Europe has been facing the spread of Coronavirus disease 2019 (COVID-19), an emerging infectious disease of viral zoonosis type, caused by the coronavirus SARS-CoV-21. This virus is responsible for an epidemic in Wuhan in November 2019 and a pandemic in March 2020. The mode of transmission, both respiratory and by contact, carried by microdroplets emitted by an infected person and inhaled by a person nearby, induces a very high contagiousness rate2. In the majority of cases, CoV-2-SARS infection is not very symptomatic, but some evolve into severe forms, particularly in frail people: elderly subjects, those affected by chronic diseases (diabetes, obesity or cancer) or those undergoing immunosuppressive treatments. There is still little information on the reasons why some will develop a severe form while others will remain asymptomatic. The immune response is little studied in this context.
Functional study of the cellular immune response has shown its interest in predicting the risk of infection in different cohorts, particularly in renal insufficiency subjects awaiting transplantation with an over-risk of developing an infection within a year in patients with a low level of gamma interferon (INFγ: main anti-viral cytokine) after non-specific stimulation of T lymphocytes.
A study published the clinical characteristics of 41 patients infected with coronavirus at the Huanan seafood market (first contact cases). Despite a similar clinical symptomatology: cough (76%) and fever (98%), some patients required rapid ventilatory assistance. These patients had an increased production of inflammatory cytokines: IL2, IL7, IL10, GSCF, IP10, MCP1, MIP1A, and TNFα3.
Here, the objective is to identify cytokine profiles in subjects exposed to or infected with SARS-CoV-2 that can predict their risk of developing a severe pauci-symptomatic form at the time of exposure or during the development of a severe form. the team believes that the immune response to this infection is a major factor in the risk of developing an asymptomatic infection, a flu-like symptomatology or a respiratory failure syndrome (ARDS).3,4 The team believes that the immune response to this infection is a major factor in the risk of developing an asymptomatic infection, a flu-like symptomatology or a respiratory failure syndrome (ARDS). The team thus wishes to better direct patients to appropriate care structures to optimise the care pathway (ambulatory, infectiology, intensive care), respirators and number of beds so as not to overload the staff) and to enable treatments to be personalised and adapted as best as possible: corticosteroids, immunomodulators, antivirals.
The study will be based on 2 axes: a first clinical axis (i) and a cellular axis (ii).
In its clinical part (i), the intensity of the immune response in COVID19 subjects presenting different forms of the disease (asymptomatic, moderate and severe forms) will be measured. These subjects will be recruited from two different patient populations:
The levels of IFNγ measured after stimulation will be compared in these 3 groups of COVID19 patients if the evolution towards inflammatory cytokinic profiles at D0, D5 and D10 can predict the risk of developing ARDS...
Then, the impact of different therapeutic interventions on the secretion of INFγ will be tested in vitro in an ancillary study (ii): anti-inflammatory, corticosteroids, anti-IL6, IL2, IL7, chloroquine on their capacity to produce anti-viral cytokines of the type INFγ on different T cells while limiting the production of pro-inflammatory cytokines by cells of innate immunity, from healthy subjects, COVID-19 subjects with a mildly symptomatic form or COVID-19 subjects with ARDS.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 303 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 722 studies on the registry; 176 are open to participants now.
Counted across the registry records on this site, refreshed daily.
1/ Medical personnel exposed to SARS-CoV-2 infection
Inclusion criteria:
Non-inclusion criteria:
Previous immunosuppressive therapy
2) Subjects hospitalized for a SARS-CoV-2 infection
Inclusion criteria:
Non-inclusion criteria:
Other: blood sampling
Other: additional blood tubes
blood sampling done on hospital staff without sars-coV-2 symptoms
Additionnal blood tube taken during the classical blood sampling in hospital
Level of IFN-gamma after a non-specific stimulation of T lymphocytes
Peripheral T lymphocytes will be stimulated with an anti-CD3 for 16-24h. The Level of IFN-gamma (pg/mL) will be defined using an automated ELISA test (Protein Simple) on the stimulated and non-stimulated plasma.
Time frame: 6 months
Plan to share: No
Ran from May 2020 to primary completion in Dec 2021, 18 months.
Of 1,295 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's 18 months is above that.
Counting every sponsor, half of 1,425 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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