Ignite Creation Date:
2024-05-06 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05128760
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-11-22
First Post:
2021-11-18
Brief Title:
Impact of Antiphospholipid Antibodies on Thrombin Generation During Sars-CoV2 Infection TACIT2 Study
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Impact of Antiphospholipid Antibodies on Thrombin Generation During Sars-CoV2 Infection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TACIT2
Brief Summary:
Context Until 70 of thrombotic event are reported during Sars-CoV2 infection Antiphospholipid antibodies aPL tests are often positive We aim to determine if aPL positivity is involved in thrombose of Sars-CoV2 infection investigating the effect of aPL on thrombin generation TG and leucocyte pathway activation neutrophils extracellular traps NETs and activation of triggering receptor expressed on myeloid cells 1 TREM-1
Method We will compare plasma from five groups of subjects patients with antiphospholipid syndrome APS and patients hospitalized for Sars-CoV-2 infection with or without aPL and as control patients with acute venous thromboembolism event and healthy volunteers For each subject we will analyze aPL activated protein C APC resistance measured by TG and leukocytes markers as circulating neutrophils extracellular traps NETs and soluble triggering receptor expressed on myeloid cells one sTREM-1 We will control aPL test at three month and analyze their persistent positivity and association with thrombotic event
Results we hypothesize that patients with COVID-19 and aPL will have a similar aPL and level of APS resistance that patients with APS Also we think that circulating NETs and sTREM-1 levels will be more important in patients with COVID-19 with aPL than patients without aPL and similar in patients with COVID-19 and aPL and patients with APS
Conclusion our study will be the first to analyze the potential role of aPL on APC resistance measured by TG and neutrophil activation in COVID-19
Method We will compare plasma from five groups of subjects patients with antiphospholipid syndrome APS and patients hospitalized for Sars-CoV-2 infection with or without aPL and as control patients with acute venous thromboembolism event and healthy volunteers For each subject we will analyze aPL activated protein C APC resistance measured by TG and leukocytes markers as circulating neutrophils extracellular traps NETs and soluble triggering receptor expressed on myeloid cells one sTREM-1 We will control aPL test at three month and analyze their persistent positivity and association with thrombotic event
Results we hypothesize that patients with COVID-19 and aPL will have a similar aPL and level of APS resistance that patients with APS Also we think that circulating NETs and sTREM-1 levels will be more important in patients with COVID-19 with aPL than patients without aPL and similar in patients with COVID-19 and aPL and patients with APS
Conclusion our study will be the first to analyze the potential role of aPL on APC resistance measured by TG and neutrophil activation in COVID-19
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None