Impact of Antiphospholipid Antibodies on Thrombin Generation During Sars-CoV2 Infection (TACIT2 Study)

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Antiphospholipid Antibodies on Thrombin Generation During Sars-CoV2 Infection.

Conditions
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COVID-19, Antiphospholipid Syndrome

Intervention / Treatment
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* Diagnostic Test: characterization of aPL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with COVID-19 and aPL positivity<br>Patient with COVID-19 and aPL test positivity | Diagnostic Test: characterization of aPL<br>* characterization of aPL profile, GT profile and leukocytes activations markers (NETs, TREM-1)<br>|
| Patients with COVID-19 without aPL positivity<br> | Diagnostic Test: characterization of aPL<br>* characterization of aPL profile, GT profile and leukocytes activations markers (NETs, TREM-1)<br>|
| APS patients<br> | Diagnostic Test: characterization of aPL<br>* characterization of aPL profile, GT profile and leukocytes activations markers (NETs, TREM-1)<br>|
| Healthy control<br> | Diagnostic Test: characterization of aPL<br>* characterization of aPL profile, GT profile and leukocytes activations markers (NETs, TREM-1)<br>|
| Disease control<br> | Diagnostic Test: characterization of aPL<br>* characterization of aPL profile, GT profile and leukocytes activations markers (NETs, TREM-1)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of activated protein C resistance and comparison between groups |  | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |