COVID-19 : Study of INFLAmmasome and PLAtelets Functions

COVID-19 Clinical Trial

— CO-QUETTES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04397822
• Other study ID #: RC31/20/0142
• Status: Completed
• Start date: April 16, 2020
• Est. completion date: May 25, 2022

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 25, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)