CO-QUETTES: COVID-19 : Study of INFLAmmasome and PLAtelets Functions

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Recruiting
CT.gov ID
NCT04397822
Collaborator
(none)
110
1
23.5
4.7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Blood samples

Detailed Description

The new Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemic started on December 2019 in China and spreaded in worldwide. The Coronavirus disease 2019 (COVID-19) is responsible of case of severe pneumonia whose the major risk is the development to ARDS. Concerning the pathophysiology, there appear to be hemostasis abnormalities including thrombocytopenia and coagulopathy. In recent studies, this thrombocytopenia is described as a risk factor to develop severe COVID-19 infection. Sepsis is associated with a major systemic inflammatory response with an increased production of pro-inflammatory cytokines. Since their discovery, inflammasomes have an important role during inflammatory response following an aggression. There are intracytoplasmic multiprotein complex activated by cellular stress or infections and is responsible for the release of pro-inflammatory cytokines, including IL-1β. Most studies have analysed inflammasomes in nucleated cells, nevertheless, little is known about inflammasomes in platelets.

Thus, the present work aims to study the activation of the platelet NLRP3 inflammasome and the platelet functions and coagulation during a SARS-CoV-2 viral pneumonia according to different levels of severity

Study Design

Study Type:
Observational
Anticipated Enrollment :
110 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study of INFLAmmasome NLRP3 and PLAtelets Functions During Severe COVID-19 Infection
Actual Study Start Date :
Apr 16, 2020
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
COVID-19 GROUP Intensive care unit

Patients suffering from COVID-19 hospitalized in intensive care unit

Biological: Blood samples
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 Standard care unit

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

Biological: Blood samples
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

Outcome Measures

Primary Outcome Measures

  1. Activation of platelet NLRP3 inflammasome [Day 0 During resuscitation (Covid-19 Resuscitation) or hospitalization (Covid-19 No Resuscitation)]

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

  2. Activation of platelet NLRP3 inflammasome [During Day 0 During resuscitation (Covid-19 Resuscitation) or hospitalization (Covid-19 No Resuscitation)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients suffering from COVID-19, hospitalized in intensive care unit and in standard care unit.
Exclusion Criteria:
  • Patients suffering from malignant blood disease, cryopyrinopathy, sickle cell disease, rheumatoid arthritis and Crohn's disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Toulouse Toulouse France 31059

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: Fanny BOUNES, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT04397822
Other Study ID Numbers:
  • RC31/20/0142
First Posted:
May 21, 2020
Last Update Posted:
Nov 30, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2020