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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05128760
Acronym
TACIT2
Enrollment
161
Registered
2021-11-22
Start date
2022-01-01
Completion date
2024-12-01
Last updated
2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiphospholipid Syndrome, COVID-19

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.

Interventions

DIAGNOSTIC_TESTcharacterization of aPL

characterization of aPL profile, GT profile and leukocytes activations markers (NETs, TREM-1)

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Frequency of activated protein C resistance and comparison between groupsat inclusion

Secondary

MeasureTime frame
frequency of positivity of each aPL test and comparison between groupsat inclusion
concentration of leucocytes activation markers and comparison between groupsat inclusion
frequency of persistent aPL test positivity and comparison between groupsat three month

Countries

France

Contacts

Primary ContactVirginie DUFROST, MD
v.dufrost@chru-nancy.fr+33383157828
Backup ContactStephane Zuily, MD, PhD
s.zuily@chru-nancy.fr+33383157354

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026