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

NCT ID: NCT04930757

Last Updated: 2021-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-04

Study Completion Date

2022-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hafid AIT-OUFELLA, Professor

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Intensive care department, Hôpital Saint Antoine

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Hafid AIT-OUFELLA, Professor

Role: CONTACT

01 49 28 23 15

Carole ELBIM, Doctor

Role: CONTACT

06 60 80 85 98

Facility Contacts

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Hafid AIT-OUFELLA, Professor

Role: primary

01 49 28 23 15

Carole ELBIM, Doctor

Role: backup

06 60 80 85 98

Other Identifiers

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APHP210061

Identifier Type: -

Identifier Source: org_study_id

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