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

June 17, 2021 updated by: Assistance Publique - Hôpitaux de Paris
The main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of circulating neutrophils in reverse migration
Time Frame: 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.
Within 4 hours following the patient admission in Intensive Care Units (ICU).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of neutrophils and platelets
Time Frame: 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
Within 4 hours following the patient admission in Intensive Care Units (ICU).
SAPS II score
Time Frame: 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).
SOFA score
Time Frame: 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).
Mortality rate
Time Frame: 2 months
The mortality occurring within 2 months of admission of patients to an ICU will also be assessed.
2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of the systemic inflammatory response upon admission to the ICU.
Time Frame: Within 4 hours following the patient admission in Intensive Care Units (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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2021

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

May 14, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 17, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP210061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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