Antiphospholipid SyndromeTACIT2NCT05128760
Impact of Antiphospholipid Antibodies on Thrombin Generation During Sars-CoV2 Infection (TACIT2 Study)
An observational study of Antiphospholipid Syndrome and COVID-19, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antiphospholipid Syndrome, COVID-19
- What is being tested?
- characterization of aPL
- How many people
- 161 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Five groups of subjects will be enrolled in the study : 1. patients hospitalized for à COVID-19 with aPL 2. patients hospitalized for à COVID-19 without aPL 3. patients with APS 4. as control, patients with acute venous thromboembolism disease 5. as control, healthy volunteers.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Virginie Dufrost
Nancy, 54500
Virginie Dufrost, MD
Stéphane Zuily, MD, PhD
About this study
Official title: Impact of Antiphospholipid Antibodies on Thrombin Generation During Sars-CoV2 Infection.
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.
Read more
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.
- Conditions
- Antiphospholipid Syndrome, COVID-19
- Being tested
- characterization of aPL
- Medical subject headings
- Antiphospholipid Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
characterization of aPLDiagnostic test
characterization of aPL profile, GT profile and leukocytes activations markers (NETs, TREM-1)
| Study group | Role | What they receive |
|---|---|---|
| Patients with COVID-19 and aPL positivity | Patient with COVID-19 and aPL test positivity Receives: Diagnostic Test: characterization of aPL | |
| Patients with COVID-19 without aPL positivity | Not described Receives: Diagnostic Test: characterization of aPL | |
| APS patients | Not described Receives: Diagnostic Test: characterization of aPL | |
| Healthy control | Not described Receives: Diagnostic Test: characterization of aPL | |
| Disease control | Not described Receives: Diagnostic Test: characterization of aPL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of activated protein C resistance and comparison between groups
Measured: at inclusion
Secondary outcomes (3)
frequency of positivity of each aPL test and comparison between groups
Measured: at inclusion
concentration of leucocytes activation markers and comparison between groups
Measured: at inclusion
frequency of persistent aPL test positivity and comparison between groups
Measured: at three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginie Dufrost, Central Hospital, Nancy, France
- Investigators
- Denis G Wahl, MD, PhD, Study director, CHRU of NancyStéphane Zuily, MD, PhD, Principal investigator, CHRU of NancyVirginie Dufrost, MD, PhD, Principal investigator, CHRU of Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128760
- Sponsor's protocol ID
- 2021-A00244-37
- Acronym
- TACIT2
- Status last verified
- Nov 2021
- First submitted
- 18 Nov 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 32369280Zuily 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.
PubMed 32572467Yalavarthi 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.
PubMed 26097119Edel 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.
PubMed 30616644
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Antiphospholipid Antibodies on Thrombin Generation During Sars-CoV2 Infection.
- ClinicalTrials.gov ID
- NCT05128760
- Acronym / sponsor ID
- TACIT2 / 2021-A00244-37
- Conditions
- Antiphospholipid Syndrome, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 161 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patients with COVID-19 and aPL positivity | – | Diagnostic Test: characterization of aPLPatient with COVID-19 and aPL test positivity |
| Patients with COVID-19 without aPL positivity | – | Diagnostic Test: characterization of aPL |
| APS patients | – | Diagnostic Test: characterization of aPL |
| Healthy control | – | Diagnostic Test: characterization of aPL |
| Disease control | – | Diagnostic Test: characterization of aPL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Five groups of subjects will be enrolled in the study : 1. patients hospitalized for à COVID-19 with aPL 2. patients hospitalized for à COVID-19 without aPL 3. patients with APS 4. as control, patients with acute venous thromboembolism disease 5. as control, healthy volunteers.
Key inclusion criteria (6 listed)
- Patient receiving a comprehensive information about the study, and not opposed to participate
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| characterization of aPLcharacterization of aPL profile, GT profile and leukocytes activations markers (NETs, TREM-1) | Diagnostic test | APS patients, Disease control, Healthy control, Patients with COVID-19 and aPL positivity, Patients with COVID-19 without aPL positivity |
Primary outcome
Frequency of activated protein C resistance and comparison between groups
Time frame: at inclusion
3 secondary outcomes
frequency of positivity of each aPL test and comparison between groups
Time frame: at inclusion
concentration of leucocytes activation markers and comparison between groups
Time frame: at inclusion
frequency of persistent aPL test positivity and comparison between groups
Time frame: at three month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Background: PubMed 32369280Bowles 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.
- Background: PubMed 32572467Zuily 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.
- Background: PubMed 26097119Yalavarthi 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.
- Background: PubMed 30616644Edel 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis G Wahl, MD, PhD study director
CHRU of Nancy
Stéphane Zuily, MD, PhD principal investigator
CHRU of Nancy
Virginie Dufrost, MD, PhD principal investigator
CHRU of Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiphospholipid Syndrome and COVID-19, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virginie DUFROST, MD (+33383157828, v.dufrost@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of activated protein C resistance and comparison between groups (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05128760, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.