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CompletedNCT04355351CovImmuneUpdated May 17, 2024

Study of Immune Response During SARS-CoV-2 Infection - (COVID-19)

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

Phase
Not applicable
Study type
Interventional
Enrollment
303
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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:

  • Subjects at risk of infection with CoV-2-SARS. We will test the Th1 response of caregivers at the time of their entry into a COVID-19 service by measuring the level of INFγ released after non-specific T-cell stimulation. The hypothesis is that a high level of INFγ at the time of exposure prevents the risk of developing severe disease and directs the patient towards less symptomatic forms. Thus, thanks to serological tests, it will be possible to determine retrospectively in this group how many subjects presented an asymptomatic form and thus to determine with the help of a functional test mimicking a viral infection the level of IFNγ measured after stimulation.
  • Patients with CoV-2-SARS infection hospitalized in the Infectious Diseases Department with a moderate form or in resuscitation with a severe form of COVID.19 The evaluation of these patients on admission using a functional test mimicking a viral infection the rate of IFNγ measured after stimulation will be carried out.

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.

02

Conditions studied

  • New Coronavirus Disease (COVID-19), Infection With SARS-CoV-2

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03

In context

COVID-19

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

1/ Medical personnel exposed to SARS-CoV-2 infection

Inclusion criteria:

  • Every willing member of medical personnel who is in charge of care, treatment or transfer of patients with COVID-19, in the hospitals of Nice, Cannes and Antibes
  • The absence of infection with SARS-CoV-2 at enrolment
  • Age > 18 years
  • Having signed an informed consent
  • Valid health insurance

Non-inclusion criteria:

  • Age \< 18 years
  • Under custody, in prison or diagnosed with a mental illness
  • Refusal to give informed consent or its withdrawal
  • Pregnant or breastfeeding
  • Known immunodeficiency
  • Previous immunosuppressive therapy

    2) Subjects hospitalized for a SARS-CoV-2 infection

Inclusion criteria:

  • All adult patients hospitalized in the intensive care or in infectious diseases units, or receiving follow-up at the dermatology unit, in Nice University Hospital, diagnosed with COVID-19 (as defined by the positivity to SARS-CoV-2 by two PCR multiplex)
  • Age > 18 years
  • Having signed an informed consent

Non-inclusion criteria:

  • Age \< 18 years
  • Under custody, in prison or diagnosed with a mental illness
  • Refusal to give informed consent or its withdrawal
  • Pregnant or breastfeeding
  • Known immunodeficiency
  • Previous immunosuppressive therapy
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
303 participants (actual)

Study arms

  • Other
    hospital staff exposed to SARS-Cov-2

    Other: blood sampling

  • Other
    SARS-Cov-2 infected patient

    Other: additional blood tubes

Interventions

  • Otherblood sampling

    blood sampling done on hospital staff without sars-coV-2 symptoms

  • Otheradditional blood tubes

    Additionnal blood tube taken during the classical blood sampling in hospital

06

What researchers measure

Primary outcomes

  1. 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

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Study locations

3 sites
  • Antibes Hospital
    Antibes, France
  • Cannes Hospital
    Cannes, France
  • Nice Hospital
    Nice, 06000, France
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References and documents

Publications

  • Buscot M, Cremoni M, Graca D, Brglez V, Courjon J, Allouche J, Teisseyre M, Boyer L, Barriere J, Chamorey E, Carles M, Seitz-Polski B. Breakthrough infections due to SARS-CoV-2 Delta variant: relation to humoral and cellular vaccine responses. Front Immunol. 2023 Mar 30;14:1145652. doi: 10.3389/fimmu.2023.1145652. eCollection 2023. PubMed 37063916 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Apr 17, 2020
First posted
Apr 21, 2020
StartActual
May 5, 2020
Primary completionActual
Dec 4, 2021
CompletionActual
Jun 22, 2022
Last update
May 17, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04355351
Responsible party
Sponsor
First posted
Apr 21, 2020
Start date
May 5, 2020
Primary completion
Dec 4, 2021
Completion
Jun 22, 2022
Last update
May 17, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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