NCT04397822

Brief Summary

COVID-19 pandemic is a severe viral sepsis characterized by the occurrence of Acute respiratory distress syndrome (ARDS) whose pathophysiology is little described

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

2.1 years

First QC Date

May 19, 2020

Last Update Submit

July 11, 2023

Conditions

COVID-19

Keywords

COVID-19NLRP3 inflammasomePlatelets functionsCoagulopathyAcute respiratory distress syndrome

Outcome Measures

Primary Outcomes (2)

  • Activation of platelet NLRP3 inflammasome

    Caspase-1 activity analyzed in patients in intensive care unit and in patients in standard care unit.

    Day 0 During resuscitation (Covid-19 Resuscitation) or hospitalization (Covid-19 No Resuscitation)

  • Activation of platelet NLRP3 inflammasome

    Labeling NOD-like receptor protein 3 (NLRP3)/Adaptor protein apoptosis-associated speck-like protein containing a CARD (ASC) analyzed in patients in intensive care unit and in patients in standard care unit.

    During Day 0 During resuscitation (Covid-19 Resuscitation) or hospitalization (Covid-19 No Resuscitation)

Study Arms (2)

COVID-19 GROUP Intensive care unit

Patients suffering from COVID-19 hospitalized in intensive care unit

Biological: Blood samples

COVID-19 GROUP Standard care unit

Patients suffering from COVID-19 hospitalized in standard care unit.

Biological: Blood samples

Interventions

Blood samplesBIOLOGICAL

Blood samples will be collected in peripheral blood at the admission in intensive care unit or in standard care unit to compare platelet inflammasome NLRP3 and others markers

COVID-19 GROUP Intensive care unitCOVID-19 GROUP Standard care unit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering from COVID-19, hospitalized in intensive care unit and in standard care unit.

You may qualify if:

  • Patients suffering from COVID-19, hospitalized in intensive care unit and in standard care unit.

You may not qualify if:

  • Patients suffering from malignant blood disease, cryopyrinopathy, sickle cell disease, rheumatoid arthritis and Crohn's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

COVID-19Hemostatic DisordersRespiratory Distress Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Fanny BOUNES

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 21, 2020

Study Start

April 16, 2020

Primary Completion

May 25, 2022

Study Completion

May 25, 2022

Last Updated

July 13, 2023

Record last verified: 2023-07

Locations

FR(1)