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

Covid19 Clinical Trial

— NeutroVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04930757
• Other study ID #: APHP210061
• Status: Recruiting
• Start date: February 4, 2021
• Est. completion date: April 2022

Study information

• Verified date: June 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Hafid AIT-OUFELLA, Professor
• Phone: 01 49 28 23 15
• Email: hafid.aitoufella[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Locations

Country	Name	City	State
France	Intensive care department, Hôpital Saint Antoine	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quantification of the systemic inflammatory response upon admission to the ICU.	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	Within 4 hours following the patient admission in Intensive Care Units (ICU).
Primary	Percentage of circulating neutrophils in reverse migration	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.	Within 4 hours following the patient admission in Intensive Care Units (ICU).
Secondary	Analysis of neutrophils and platelets	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; Phenotypic and functional analysis of neutrophils; Measurement of the oxidative explosion; Measurement of neutrophil apoptosis; Measurement of intravascular NETosis; 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), a2-Plasmin-Plasmin-inhibitor	Within 4 hours following the patient admission in Intensive Care Units (ICU).
Secondary	SAPS II score	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).
Secondary	SOFA score	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).
Secondary	Mortality rate	The mortality occurring within 2 months of admission of patients to an ICU will also be assessed.	2 months