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

Completed

• Conditions: Covid19

• Registration Number: NCT04594356
• Lead Sponsor: Fondation Hôpital Saint-Joseph

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-20
• Study Start: 2020-11-19
• Primary Completion: 2021-01-31
• Status Verified: 2023-04
• Study Completion: 2023-04-26
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the netosis process	Day 1	This outcome corresponds to the of the determination of DNA-myeloperoxidase complexes (DNA-MPO).

Secondary Outcome Measures

Name	Time	Method
Evaluation of the netosis process at day 3	Day 3	This outcome corresponds to the of the determination of DNA-myeloperoxidase complexes (DNA-MPO).
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.

Trial Locations

Locations (2)

CHU Bichat Claude Bernard; 🇫🇷 Paris, France

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France