NET_COV: Assessment of Netosis During COVID-19, Under Treatment With Anakinra, an Interleukin-1 Receptor Antagonist

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04594356
Collaborator
(none)
120
2
25.3
60
2.4

Study Details

Study Description

Brief Summary

During their activation in response to an infectious stimulus or during chronic inflammatory processes, blood and tissue neutrophils modify their functional phenotype and produce numerous toxic mediators. In particular, they rapidly release chromatin filaments covered with numerous granular and cytoplasmic components called "Neutrophil Extracellular Traps" (NETs). This phenomenon, called netosis, has been implicated in many diseases, in particular in viral infections during which this response can be useful for the anti-infectious response at the initial phase, then deleterious when it becomes toxic. for the tissue environment. This has been shown in particular during post-pneumonia acute respiratory distress syndrome.

The intensity of netosis is therefore an early factor in activating neutrophils and inflammation. Given the major biological signs of inflammation observed in patients with COVID-19 as soon as they enter the hospital [C-Reactive protein (CRP), Interleukin-6 (IL-6), D-dimers, etc.), it seems particularly interesting to better document this inflammation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Assessment of Netosis During COVID-19, Under Treatment With Anakinra, an Interleukin-1 Receptor Antagonist
    Actual Study Start Date :
    Nov 19, 2020
    Actual Primary Completion Date :
    Jan 31, 2021
    Anticipated Study Completion Date :
    Dec 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with COVID-19 infection

    As part of this research, existing clinical data of patients infected with COVID-19 is collected from the patients' computerized medical records. During the hospitalization of the patients, in addition to the clinical and laboratory data collected, the dosage of IL-6, apparently playing a central role in the worsening of the symptoms of COVID-19, was performed. The remainder of the contents of the tube used to perform this assay will allow further research by assaying the DNA-myeloperoxidase (DNA-MPO) complexes. These complexes reflect a phenomenon called "netosis," most likely involved in the widespread inflammation that patients have suffered from.

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of the netosis process [Day 1]

      This outcome corresponds to the of the determination of DNA-myeloperoxidase complexes (DNA-MPO).

    Secondary Outcome Measures

    1. Evaluation of the netosis process at day 3 [Day 3]

      This outcome corresponds to the of the determination of DNA-myeloperoxidase complexes (DNA-MPO).

    2. Link between this marker (DNA-MPO) and the clinical course of patients [Day 3]

      This outcome is to evaluate the clinical course of patients according to the DNA-MPO marker.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients aged ≥ 18 years

    • Patients hospitalized within the Paris Saint-Joseph Hospital Group for whom the diagnosis of COVID-19 has been established on the basis of a PCR positive for SARS-CoV 19 using a nasal swab and/or a typical chest CT scan

    • Patients with a severe or aggravating form of COVID-19, based on an oxygen saturation ≤93% under 6 l/min of nasal oxygen or a saturation ≤93% under 4 l/min oxygen with a decrease in saturation of at least 3% during the last 24 hours, in ambient air

    • Patients treated with Anakinra

    • Patients for whom IL-6 assays have been performed

    • French speaking patients

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Paris Saint-Joseph Paris France 75014
    2 CHU Bichat Claude Bernard Paris France 75018

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    • Principal Investigator: Gilles HAYEM, MD, Groupe Hospitalier Paris Saint Joseph

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT04594356
    Other Study ID Numbers:
    • NET_COV
    First Posted:
    Oct 20, 2020
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022