Impact of Antiphospholipid Antibodies on Thrombin Generation During Sars-CoV2 Infection (TACIT2 Study)
NCT ID: NCT05128760
Last Updated: 2021-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
161 participants
OBSERVATIONAL
2022-01-01
2024-12-01
Brief Summary
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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
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with COVID-19 and aPL positivity
Patient with COVID-19 and aPL test positivity
characterization of aPL
characterization of aPL profile, GT profile and leukocytes activations markers (NETs, TREM-1)
Patients with COVID-19 without aPL positivity
characterization of aPL
characterization of aPL profile, GT profile and leukocytes activations markers (NETs, TREM-1)
APS patients
characterization of aPL
characterization of aPL profile, GT profile and leukocytes activations markers (NETs, TREM-1)
Healthy control
characterization of aPL
characterization of aPL profile, GT profile and leukocytes activations markers (NETs, TREM-1)
Disease control
characterization of aPL
characterization of aPL profile, GT profile and leukocytes activations markers (NETs, TREM-1)
Interventions
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characterization of aPL
characterization of aPL profile, GT profile and leukocytes activations markers (NETs, TREM-1)
Eligibility Criteria
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Inclusion Criteria
\+ 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 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
18 Years
ALL
Yes
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Virginie Dufrost
Dr
Principal Investigators
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Denis G Wahl, MD, PhD
Role: STUDY_DIRECTOR
CHRU of Nancy
Stéphane Zuily, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHRU of Nancy
Virginie Dufrost, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHRU of Nancy
Locations
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Virginie Dufrost
Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Virginie Dufrost, MD
Role: primary
References
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Bowles L, Platton S, Yartey N, Dave M, Lee K, Hart DP, MacDonald V, Green L, Sivapalaratnam S, Pasi KJ, MacCallum P. Lupus Anticoagulant and Abnormal Coagulation Tests in Patients with Covid-19. N Engl J Med. 2020 Jul 16;383(3):288-290. doi: 10.1056/NEJMc2013656. Epub 2020 May 5. No abstract available.
Zuily S, de Laat B, Guillemin F, Kelchtermans H, Magy-Bertrand N, Desmurs-Clavel H, Lambert M, Poindron V, de Maistre E, Dufrost V, Risse J, Shums Z, Norman GL, de Groot PG, Lacolley P, Lecompte T, Regnault V, Wahl D. Anti-Domain I beta2-Glycoprotein I Antibodies and Activated Protein C Resistance Predict Thrombosis in Antiphospholipid Syndrome: TAC(I)T Study. J Appl Lab Med. 2020 Nov 1;5(6):1242-1252. doi: 10.1093/jalm/jfaa072.
Yalavarthi S, Gould TJ, Rao AN, Mazza LF, Morris AE, Nunez-Alvarez C, Hernandez-Ramirez D, Bockenstedt PL, Liaw PC, Cabral AR, Knight JS. Release of neutrophil extracellular traps by neutrophils stimulated with antiphospholipid antibodies: a newly identified mechanism of thrombosis in the antiphospholipid syndrome. Arthritis Rheumatol. 2015 Nov;67(11):2990-3003. doi: 10.1002/art.39247.
Edel Y, Kliminski V, Pokroy-Shapira E, Oren S, Dortort Lazar A, Pri-Paz Basson Y, Egbaria M, Molad Y. Elevated plasma level of soluble triggering receptor expressed on myeloid cells-1 is associated with inflammation activity and is a potential biomarker of thrombosis in primary antiphospholipid syndrome. Arthritis Res Ther. 2019 Jan 7;21(1):10. doi: 10.1186/s13075-018-1779-5.
Other Identifiers
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2021-A00244-37
Identifier Type: -
Identifier Source: org_study_id