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

NCT04594356 | Completed

• 1 other identifier: NET_COV
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Evaluation of the netosis process

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

  Day 1

Secondary Outcomes (2)

• Evaluation of the netosis process at day 3

  Day 3

• Link between this marker (DNA-MPO) and the clinical course of patients

  Day 3

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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, 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

You may qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (2)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

CHU Bichat Claude Bernard

Paris, 75018, France

Location

Related Publications (11)

• Twaddell SH, Baines KJ, Grainge C, Gibson PG. The Emerging Role of Neutrophil Extracellular Traps in Respiratory Disease. Chest. 2019 Oct;156(4):774-782. doi: 10.1016/j.chest.2019.06.012. Epub 2019 Jun 29.

  PMID: 31265835 BACKGROUND

• Granger V, Peyneau M, Chollet-Martin S, de Chaisemartin L. Neutrophil Extracellular Traps in Autoimmunity and Allergy: Immune Complexes at Work. Front Immunol. 2019 Dec 3;10:2824. doi: 10.3389/fimmu.2019.02824. eCollection 2019.

  PMID: 31849989 BACKGROUND

• Bendib I, de Chaisemartin L, Granger V, Schlemmer F, Maitre B, Hue S, Surenaud M, Beldi-Ferchiou A, Carteaux G, Razazi K, Chollet-Martin S, Mekontso Dessap A, de Prost N. Neutrophil Extracellular Traps Are Elevated in Patients with Pneumonia-related Acute Respiratory Distress Syndrome. Anesthesiology. 2019 Apr;130(4):581-591. doi: 10.1097/ALN.0000000000002619.

  PMID: 30676417 BACKGROUND

• Chen G, Wu D, Guo W, Cao Y, Huang D, Wang H, Wang T, Zhang X, Chen H, Yu H, Zhang X, Zhang M, Wu S, Song J, Chen T, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest. 2020 May 1;130(5):2620-2629. doi: 10.1172/JCI137244.

  PMID: 32217835 BACKGROUND

• Ruan Q, Yang K, Wang W, Jiang L, Song J. Correction to: Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 Jun;46(6):1294-1297. doi: 10.1007/s00134-020-06028-z.

  PMID: 32253449 BACKGROUND

• Sarzi-Puttini P, Giorgi V, Sirotti S, Marotto D, Ardizzone S, Rizzardini G, Antinori S, Galli M. COVID-19, cytokines and immunosuppression: what can we learn from severe acute respiratory syndrome? Clin Exp Rheumatol. 2020 Mar-Apr;38(2):337-342. doi: 10.55563/clinexprheumatol/xcdary. Epub 2020 Mar 22.

  PMID: 32202240 BACKGROUND

• Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

  PMID: 32192578 BACKGROUND

• Kupferschmidt K, Cohen J. Race to find COVID-19 treatments accelerates. Science. 2020 Mar 27;367(6485):1412-1413. doi: 10.1126/science.367.6485.1412. No abstract available.

  PMID: 32217705 BACKGROUND

• Mahase E. Covid-19: what treatments are being investigated? BMJ. 2020 Mar 26;368:m1252. doi: 10.1136/bmj.m1252. No abstract available.

  PMID: 32217607 BACKGROUND

• Li G, De Clercq E. Therapeutic options for the 2019 novel coronavirus (2019-nCoV). Nat Rev Drug Discov. 2020 Mar;19(3):149-150. doi: 10.1038/d41573-020-00016-0. No abstract available.

  PMID: 32127666 BACKGROUND

• Granger V, Fels A, Huet T, Laplanche JL, Laplanche S, Chatellier G, Beaussier H, Chollet-Martin S, de Chaisemartin L, Hayem G. Circulating IL-6 but not neutrophil extracellular traps levels can predict anakinra effectiveness in patients with severe COVID-19. J Leukoc Biol. 2022 Dec;112(6):1365-1367. doi: 10.1002/JLB.4LT0122-018RR. Epub 2022 Jun 15.

  PMID: 35704508 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gilles HAYEM, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 20, 2020
• Study Start: November 19, 2020
• Primary Completion: January 31, 2021
• Study Completion: April 26, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

FR (2)