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Clinical Trials/NCT04930757
NCT04930757UnknownNot Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country200 target enrollmentStarted: February 4, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
200
Locations
1
Primary Endpoint
Percentage of circulating neutrophils in reverse migration

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Analysis of neutrophils and platelets(Within 4 hours following the patient admission in Intensive Care Units (ICU).)
  • 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).)
  • 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).)
  • Mortality rate(2 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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