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

NCT ID: NCT04594356

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-19

Study Completion Date

2023-04-26

Brief Summary

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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

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Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles HAYEM, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

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Groupe Hospitalier Paris Saint-Joseph

Paris, , France

Site Status

CHU Bichat Claude Bernard

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 31265835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31849989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30676417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32217835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32253449 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32202240 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32192578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32217705 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 32217607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32127666 (View on PubMed)

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.

Reference Type RESULT
PMID: 35704508 (View on PubMed)

Other Identifiers

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NET_COV

Identifier Type: -

Identifier Source: org_study_id

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