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

NCT04930757 | Unknown

• 1 other identifier: APHP210061
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid19

Keywords

Covid19; Neutrophils; Platelet aggregation activation; Clinical scores; SAPS II ("simplified acute physiology"); SOFA ("Sequential Organ Failure Assessment"); Global respiratory and non-respiratory scores

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Other Outcomes (1)

• Quantification of the systemic inflammatory response upon admission to the ICU.

  Within 4 hours following the patient admission in Intensive Care Units (ICU).

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patients under guardianship / curatorship
• Patients under AME

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Intensive care department, Hôpital Saint Antoine

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hafid AIT-OUFELLA, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hafid AIT-OUFELLA, Professor

CONTACT

01 49 28 23 15; hafid.aitoufella@aphp.fr

Carole ELBIM, Doctor

CONTACT

06 60 80 85 98; carole.elbim@sorbonne-universite.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: June 18, 2021
• Study Start: February 4, 2021
• Primary Completion: February 1, 2022
• Study Completion: April 1, 2022
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

FR (1)