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CompletedNCT04385017CoVInnateUpdated Mar 22, 2023

Role of Inflammasomes in COVID-19 Disease

An interventional study of COVID-19 patients in COVID-19 by SARS-CoV-2 Infection, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-22.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
99
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

As of March 25, 2020, 414,179 cases and 18,440 deaths secondary to Coronavirus 2019 disease (COVID-19) have been reported worldwide. The unfavorable course of the patients is characterized on the immunological level by an intense pro-inflammatory response which can go as far as a cytokinic storm. This pandemic affects a naive world population from an immunological point of view with respect to SARS-CoV-2 responsible for COVID-19. The evolution is favorable without hospitalization in almost 85% of cases. Among patients hospitalized for pneumonia, some will not require ventilatory support while others will need intensive care. To date, two main types of unfavorable evolution have been described. The first is a bi-phasic evolution beginning with a paucisymptomatic form which is worsened secondarily with respiratory distress associated with a decrease in the viral load in the airways. The second is associated with persistent high viral loads in the airways and detection of the virus in the blood. These different clinical profiles could depend on the quantitative and qualitative response of the innate immune system.

At the early stage of a viral infection the innate immunity is capable of detecting certain conserved microbial patterns (PAMP, pathogen-associated molecular pattern) recognized by receptors dedicated to these patterns (PRR, pattern recognition receptor). This process allows to initiate the pro-inflammatory response via different signaling pathways.

Activating multiprotein complexes called inflammasomes, which cause pro-IL-1β and pro-IL-18 to be transformed into active pro-inflammatory cytokines are one of these pathways.

The central role of inflammasomes in the secretion of these pro-inflammatory cytokines deserves an in-depth study of their activation during COVID-19, whereas the inadequate inflammatory response appears to be the determining factor in the unfavorable development of patients.

The objective of this project is to analyze the level of activation of the inflammasomes and then to search for inactivating or activating mutations among the genes which code for the proteins constituting the inflammasomes in Covid-19 patients. The identification of mutations in patients with a serious clinical presentation or even death would be followed by fundamental work by analyzing in a cellular model the impact of these mutations on the secretion of IL-1β.

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Conditions studied

  • COVID-19 by SARS-CoV-2 Infection

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In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 99 is close to the median of 100 across 4,098 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 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
No

Inclusion criteria

  • Age above 18 years old. SARS-CoV-2 infection confirmed by RT PCR or by serology Hospitalised patients with less than 14 days of COVID-19 symptoms. Date of first symptom being defined as to the date of one of the following symptoms : cough, dyspnea, fever above 38 °C, anosmia, dysgeusia or ageusia, chilblain Lupus erythematous Women of fertile age using at least one contraceptive method Health insurance Written informed consent

Exclusion criteria

Exclusion criteria

  • Pregnant or breastfeeding female
  • Human immunodeficiency virus infection with CD4 under 200 cell/mm3
  • Aplasia
  • at-risk patients (minor, patient under judicial protection or tutorship)
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
99 participants (actual)

Study arms

  • Other
    DNA from monocytes

    It will consist in the collection of 2 additional tubes at their blood draw. For DNA analysis, informed consent will be collected in writing

    Other: COVID-19 patients

Interventions

  • OtherCOVID-19 patients

    It will consist in the collection of 2 additional tubes at their blood draw. For DNA analysis, informed consent will be collected in writing

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What researchers measure

Primary outcomes

  1. Level of activation of inflammasomes in monocytes and polymorphonuclear neutrophils during COVID-19

    Percentage of immune cells with inflammasome positive labeling using flow cytometry in comparison to controls

    Time frame: At inclusion

Secondary outcomes

  1. Genes nucleoside polymorphism analysis

    Identification of genes nucleotide polymorphisms by Whole Exome Sequensing and bioinformatics analysis. Analysis of activating or inactivating mutations of NLRP3 NLRC4 AIM2 and Pyrin inflammasomes in patients with severe COVID-19.

    Time frame: At inclusion

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Study locations

2 sites
  • Ch Cannes, Réanimation
    Cannes, Alpes Maritimes 06, France
  • CHU de nice
    Nice, Alpes-Maritimes 06200, France
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References and documents

Publications

  • Courjon J, Dufies O, Robert A, Bailly L, Torre C, Chirio D, Contenti J, Vitale S, Loubatier C, Doye A, Pomares-Estran C, Gonfrier G, Lotte R, Munro P, Visvikis O, Dellamonica J, Giordanengo V, Carles M, Yvan-Charvet L, Ivanov S, Auberger P, Jacquel A, Boyer L. Heterogeneous NLRP3 inflammasome signature in circulating myeloid cells as a biomarker of COVID-19 severity. Blood Adv. 2021 Mar 9;5(5):1523-1534. doi: 10.1182/bloodadvances.2020003918. PubMed 33683342 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2023, 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
NCT04385017
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
May 12, 2020
Start date
May 11, 2020
Primary completion
Feb 1, 2022
Completion
Dec 30, 2022
Last update
Mar 22, 2023

Study contacts

COURJON Johan
principal investigator · CHU de Nice, Infectiologie

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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