Impact of Antiphospholipid Antibodies on Thrombin Generation During Sars-CoV2 Infection (TACIT2 Study)
- Conditions
- COVID-19Antiphospholipid Syndrome
- Interventions
- Diagnostic Test: characterization of aPL
- Registration Number
- NCT05128760
- Lead Sponsor
- Central Hospital, Nancy, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 161
-
Patient receiving a comprehensive information about the study, and not opposed to participate
- one criterion among :
-
patient hospitalized fo a COVID-19
-
Patient with known APS
-
Patients hospitalized for an acute venous thromboembolism event aPL positivity or COVID-19
-
healthy volunteers
- For all participants : pregnancy, age below 18 years-old, absence of written informed consent , autoimmune or inflammatory disease except antiphospholipid syndrome
- For patients with COVID-19: previous aPL positivity (before COVID-19 infection)
- For patients with APS: previous symptomatic COVID-19 infection
- For patients control with acute venous thromboembolism event: previous symptomatic COVID-19 infection, infection or inflammatory disease in flare at the time of thromboembolism event, known aPL positivity
- For Healthy volunteers: history of thrombosis (venous, arterial or small vessels), previous symptomatic COVID-19 infection, infection or inflammatory disease in flare at the time of inclusion, known aPL positivity
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with COVID-19 without aPL positivity characterization of aPL - Patients with COVID-19 and aPL positivity characterization of aPL Patient with COVID-19 and aPL test positivity APS patients characterization of aPL - Healthy control characterization of aPL - Disease control characterization of aPL -
- Primary Outcome Measures
Name Time Method Frequency of activated protein C resistance and comparison between groups at inclusion
- Secondary Outcome Measures
Name Time Method frequency of positivity of each aPL test and comparison between groups at inclusion concentration of leucocytes activation markers and comparison between groups at inclusion frequency of persistent aPL test positivity and comparison between groups at three month
Trial Locations
- Locations (1)
Virginie Dufrost
🇫🇷Nancy, France