Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
The main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Hafid AIT-OUFELLA, Professor | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive care department, Hôpital Saint Antoine | Recruiting | Paris | 75012 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
| Within 4 hours following the patient admission in Intensive Care Units (ICU). |
| 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). |
| 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). |
| Mortality rate | The mortality occurring within 2 months of admission of patients to an ICU will also be assessed. | 2 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |