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

Study of INFLAmmasome NLRP3 and PLAtelets Functions During Severe COVID-19 Infection

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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

• Study Contact: Name: Fanny BOUNES; Phone Number: 05 61 32 27 99; Email: bounes.f@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Fanny BOUNES, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2020
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Acute respiratory distress syndrome; NLRP3 inflammasome; Coagulopathy; Platelets functions
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RC31/20/0142

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No