Involvement of Polymorphonuclear Neutrophils and Platelets in Severe Form of COVID-19 (NeutroVID)
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
This is a non-interventional transversal research whose main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19.
Design:
A multicentric (3 sites) clinical trial
Sample size :
200 patients
Population concerned:
Patients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab.
Duration of participation (treatment + follow-up): until the patient is discharged from the ICU and within 2 months top.
No interim analysis is planned. Analysis will be performed at the end of the study.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Carole ELBIM, Doctor
- Telefonnummer: 06 60 80 85 98
- E-post: carole.elbim@sorbonne-universite.fr
Studieorter
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-
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Paris, Frankrike, 75012
- Rekrytering
- Intensive care department, Hôpital Saint Antoine
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Kontakt:
- Carole ELBIM, Doctor
- Telefonnummer: 06 60 80 85 98
- E-post: carole.elbim@sorbonne-universite.fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients admitted to the intensive care units of Saint-Antoine, Tenon and Pitié-Salpêtrière hospitals (Paris, France)
- With moderate to severe respiratory distress syndrome and SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab
- informed and not opposed to participation in research
- included within 4 hours following the paatient's admission
Exclusion Criteria:
- Patients under guardianship / curatorship
- Patients under AME
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
Patients with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab.
Patients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of circulating neutrophils in reverse migration
Tidsram: Within 4 hours following the patient admission in Intensive Care Units (ICU).
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Percentage of circulating neutrophils in reverse migration determined on a sample taken during the admission of COVID 19 patients to Intensive Care Units by flow cytometry: the samples will be incubated for 45 minutes with anti-human CXCR1, CD11c, CD11b, and CD62L antibodies.
Erythrocytes will be lysed and fixed leukocytes will be analyzed by flow cytometry.
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Within 4 hours following the patient admission in Intensive Care Units (ICU).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Analysis of neutrophils and platelets
Tidsram: Within 4 hours following the patient admission in Intensive Care Units (ICU).
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The analysis of neutrophils and platelets, and of the inflammatory environment will be carried out on a sample taken on admission of patients to Intensive Care Units
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Within 4 hours following the patient admission in Intensive Care Units (ICU).
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SAPS II score
Tidsram: From admission to the follow-up visits (Day 3, Day 7 and as part of usual care every 7 days until the patient is discharged and within 2 months top).
|
Assessment of the link between phenotypic and functional markers of neutrophils on admission to the ICU. The severity of the disease is determined using clinical scores (SAPS II ("simplified acute physiology") and SOFA ("Sequential Organ Failure Assessment") (global SOFA, respiratory and non-respiratory) scores; these scores will be assessed during the period of hospitalization in Intensive Care Units. An association between these 2 scores (SAPSII and SOFA scores) and the neutrophil markers will be sought. |
From admission to the follow-up visits (Day 3, Day 7 and as part of usual care every 7 days until the patient is discharged and within 2 months top).
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|
SOFA score
Tidsram: From admission to the follow-up visits (Day 3, Day 7 and as part of usual care every 7 days until the patient is discharged and within 2 months top).
|
Assessment of the link between phenotypic and functional markers of neutrophils on admission to the ICU. The severity of the disease is determined using clinical scores (SAPS II ("simplified acute physiology") and SOFA ("Sequential Organ Failure Assessment") (global SOFA, respiratory and non-respiratory) scores; these scores will be assessed during the period of hospitalization in Intensive Care Units. An association between these 2 scores (SAPSII and SOFA scores) and the neutrophil markers will be sought. |
From admission to the follow-up visits (Day 3, Day 7 and as part of usual care every 7 days until the patient is discharged and within 2 months top).
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Mortality rate
Tidsram: 2 months
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The mortality occurring within 2 months of admission of patients to an ICU will also be assessed.
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2 months
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Quantification of the systemic inflammatory response upon admission to the ICU.
Tidsram: Within 4 hours following the patient admission in Intensive Care Units (ICU).
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Circulating levels of proinflammatory cytokines (IL-1bêta, IL-6, IL-8, TNFalpha, TGFbêta, IFNgamma, IL-17, IL-21, IL-22, IL-23, and IL-10) will be measured by Luminex and the levels of soluble adhesion molecules and in particular of soluble JAM-C and soluble mediators will be measured by ELISA
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Within 4 hours following the patient admission in Intensive Care Units (ICU).
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Samarbetspartners och utredare
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- APHP210061
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