Involvement of Polymorphonuclear Neutrophils and Platelets in Severe Form of COVID-19

• Conditions: Covid19

• Registration Number: NCT04930757
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19.

Detailed Description

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.

Study Timeline

• Study Start: 2021-02-04
• Study First Submitted: 2021-05-14
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-17
• Last Update Submitted: 2021-06-17
• Study First Posted: 2021-06-18
• Last Update Posted: 2021-06-18
• Primary Completion: 2022-02
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of circulating neutrophils in reverse migration	Within 4 hours following the patient admission in Intensive Care Units (ICU).	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.

Secondary Outcome Measures

Name	Time	Method
Analysis of neutrophils and platelets	Within 4 hours following the patient admission in Intensive Care Units (ICU).	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; 1. Phenotypic and functional analysis of neutrophils; * Measurement of the oxidative explosion; * Measurement of neutrophil apoptosis; * Measurement of intravascular NETosis; 2. Analysis of platelet aggregation and activation; * Quantification of the fraction of immature platelets (IPF); * Contribution of platelets to clot stiffness; * ELISA assay of soluble platelet activation markers; * Measurement of D-Dimers, von Willebrand factor, thrombin-antithrombin complex (TAT), α2-Plasmin-Plasmin-inhibitor
SAPS II score	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.
SOFA score	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.
Mortality rate	2 months	The mortality occurring within 2 months of admission of patients to an ICU will also be assessed.

Trial Locations

Locations (1)

Intensive care department, Hôpital Saint Antoine; 🇫🇷 Paris, France