Clinical trial NCT04930757: Involvement of Polymorphonuclear Neutrophils and Platelets in Severe Form of COVID-19
Official title: Involvement of Polymorphonuclear Neutrophils and Platelets in Severe Form of COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2021-06-18
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of circulating neutrophils in reverse migration
timeFrame: Within 4 hours following the patient admission in Intensive Care Units (ICU).
Secondary outcomes:
measure: Analysis of neutrophils and platelets
timeFrame: Within 4 hours following the patient admission in Intensive Care Units (ICU).
measure: SAPS II score
timeFrame: 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).
measure: SOFA score
timeFrame: 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).
measure: Mortality rate
timeFrame: 2 months
Other outcomes:
measure: Quantification of the systemic inflammatory response upon admission to the ICU.
timeFrame: Within 4 hours following the patient admission in Intensive Care Units (ICU).
Locations:
city: Paris
country: France
facility: Intensive care department, Hôpital Saint Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Hafid AIT-OUFELLA, Professor
role: PRINCIPAL_INVESTIGATOR
References: