Antiphospholipid SyndromeAPSantiCoNCT05313048
Prospective Observational Study to Evaluate a Possible Change in APS Antibody Profiles After COVID-19 Infection or Vaccination
An observational study of Antiphospholipid Syndrome and COVID-19 Infection, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
Trial summary
Prospective observational study to evaluate a possible change in APS antibody profiles after COVID-19 infection or vaccination Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antiphospholipid Syndrome, COVID-19 Infection, COVID-19 Vaccination
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- 15 Mar 2022to 24 Oct 2022
- How long will I take part?
- 12 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with antiphospholipid syndrome with thromboembolic clinical manifestations (venous thromboembolism, pulmonary embolism, thrombophlebitis etc.) or Patients with APS antibody risk profile (single/double/triple positivity)
Who may be able to join
- Minimum age of 18 years
- Confirmed antiphospholipid syndrome with thromboembolic clinical manifestations (venous thromboembolism, pulmonary embolism, thrombophlebitis etc.)
- Patients with APS antibody risk profile (single/double/triple positivity)
- Written consent for participation in the prospective APSantiCo observational study
Who cannot join
- APS with isolated pregnancy complications
- No anticoagulation medication
- Inadequately diagnosed APS
- Non-compliance on the part of the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The APSantiCo Observational Study - Prospective Observational Study to Evaluate a Possible Change in APS Antibody Profiles After COVID-19 Infection or Vaccination
Prospective observational study to evaluate a possible change in APS antibody profiles after COVID-19 infection or vaccination
Read the detailed description
Prospective observational study to evaluate a possible change in antiphospholipid antibody profiles after coronavirus disease 2019 (COVID-19) infection or vaccination.
Patients with antiphospholipid syndrome (APS) with thromboembolic complications recorded using the retrospective database of the APSANTICO registry (ClinicalTrials.gov Identifier: NCT05195372) will serve as a baseline for a prospective observational study to investigate the extent to which COVID 19 infection and/or COVID 19 vaccination alters APS antibody profiles.
Current literature suggests that patients who have been or are infected with COVID-19 are at higher risk of thrombosis. This increased risk is due to, among other things, damaged endothelium, slower blood flow and observed hypercoagulability of the blood.
It has also been described that COVID-19 patients may have a higher prevalence of lupus anticoagulant. Based on these assumptions, one of the aims of the prospective observational study is to determine whether and to what extent COVID-19 infection affects the antibody profile of APS patients.
In addition, atypical thrombosis with thrombocytopenia has been repeatedly reported recently as a rare side effect after COVID-19 vaccination with two recombinant adenoviral vectors encoding the spike protein antigen of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (ChAdOx1 nCov-19, AstraZeneca and Ad26.COV2.S, Johnson\&Johnson).
The extent to which thrombosis could also occur after messenger RNA (mRNA) vaccines has not yet been clearly proven.
Furthermore, it is unclear whether COVID-19 infections and/or vaccinations can possibly influence the expression and level of antiphospholipid antibody titres. Therefore, another aim of the prospective observational study is to compare the antiphospholipid antibody results available from the retrospective registry before COVID-19 vaccination or COVID-19 infection with the antibody results after COVID-19 infection and/or vaccination. For this purpose, the patients who were recorded in the retrospective register are contacted by post with an information letter and then called in by telephone to the investigators coagulation centre for a follow-up examination after the COVID-19 vaccinations have been carried out and/or after COVID-19 infection. Then, during this examination, a blood sample is taken to monitor the course of the antiphospholipid antibodies. In addition, patients are offered a test of COVID-19 nucleocapsid antibodies and COVID-19 spike antibodies free of charge to check the success of the vaccination. This is of particular interest as some of these patients are taking immunosuppressive drugs due to an underlying autoimmune disease, which could weaken the immune response.
- Medical subject headings
- Antiphospholipid Syndrome, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
change in APS antibody status after surviving COVID-19 infection and/or receiving COVID-19 vaccination
The main observational variable is the change in APS antibody status in patients with antiphospholipid syndrome after surviving COVID-19 infection and/or receiving COVID-19 vaccination.
Measured: 2015-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start15 Mar 2022
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- 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
- 82 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Cardioangiologisches Centrum Bethanien
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. E. Lindhoff-Last, Cardioangiologisches Centrum Bethanien
- Investigators
- Edelgard Lindhoff-Last, Prof. MD, Study chair, Cardioangiology Center Bethanien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313048
- Sponsor's protocol ID
- APSantiCo-Study
- Acronym
- APSantiCo
- Status last verified
- Dec 2022
- First submitted
- 5 Apr 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The APSantiCo Observational Study - Prospective Observational Study to Evaluate a Possible Change in APS Antibody Profiles After COVID-19 Infection or Vaccination
- ClinicalTrials.gov ID
- NCT05313048
- Acronym / sponsor ID
- APSantiCo / APSantiCo-Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Cardioangiologisches Centrum BethanienUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 6 Apr 2022 (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.
Prospective observational study to evaluate a possible change in APS antibody profiles after COVID-19 infection or vaccination
Detailed description
Prospective observational study to evaluate a possible change in antiphospholipid antibody profiles after coronavirus disease 2019 (COVID-19) infection or vaccination.
Patients with antiphospholipid syndrome (APS) with thromboembolic complications recorded using the retrospective database of the APSANTICO registry (ClinicalTrials.gov Identifier: NCT05195372) will serve as a baseline for a prospective observational study to investigate the extent to which COVID 19 infection and/or COVID 19 vaccination alters APS antibody profiles.
Current literature suggests that patients who have been or are infected with COVID-19 are at higher risk of thrombosis. This increased risk is due to, among other things, damaged endothelium, slower blood flow and observed hypercoagulability of the blood.
It has also been described that COVID-19 patients may have a higher prevalence of lupus anticoagulant. Based on these assumptions, one of the aims of the prospective observational study is to determine whether and to what extent COVID-19 infection affects the antibody profile of APS patients.
In addition, atypical thrombosis with thrombocytopenia has been repeatedly reported recently as a rare side effect after COVID-19 vaccination with two recombinant adenoviral vectors encoding the spike protein antigen of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (ChAdOx1 nCov-19, AstraZeneca and Ad26.COV2.S, Johnson\&Johnson).
The extent to which thrombosis could also occur after messenger RNA (mRNA) vaccines has not yet been clearly proven.
Furthermore, it is unclear whether COVID-19 infections and/or vaccinations can possibly influence the expression and level of antiphospholipid antibody titres. Therefore, another aim of the prospective observational study is to compare the antiphospholipid antibody results available from the retrospective registry before COVID-19 vaccination or COVID-19 infection with the antibody results after COVID-19 infection and/or vaccination. For this purpose, the patients who were recorded in the retrospective register are contacted by post with an information letter and then called in by telephone to the investigators coagulation centre for a follow-up examination after the COVID-19 vaccinations have been carried out and/or after COVID-19 infection. Then, during this examination, a blood sample is taken to monitor the course of the antiphospholipid antibodies. In addition, patients are offered a test of COVID-19 nucleocapsid antibodies and COVID-19 spike antibodies free of charge to check the success of the vaccination. This is of particular interest as some of these patients are taking immunosuppressive drugs due to an underlying autoimmune disease, which could weaken the immune response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with antiphospholipid syndrome with thromboembolic clinical manifestations (venous thromboembolism, pulmonary embolism, thrombophlebitis etc.) or Patients with APS antibody risk profile (single/double/triple positivity)
Key inclusion criteria (4 listed)
- Minimum age of 18 years
- Confirmed antiphospholipid syndrome with thromboembolic clinical manifestations (venous thromboembolism, pulmonary embolism, thrombophlebitis etc.)
- Patients with APS antibody risk profile (single/double/triple positivity)
- Written consent for participation in the prospective APSantiCo observational study
Key exclusion criteria (4 listed)
- APS with isolated pregnancy complications
- No anticoagulation medication
- Inadequately diagnosed APS
- Non-compliance on the part of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in APS antibody status after surviving COVID-19 infection and/or receiving COVID-19 vaccination
Time frame: 2015-2022
The main observational variable is the change in APS antibody status in patients with antiphospholipid syndrome after surviving COVID-19 infection and/or receiving COVID-19 vaccination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Edelgard Lindhoff-Last, Prof. MD study chair
Cardioangiology Center Bethanien
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 Infection, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 21 Dec 2022. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in APS antibody status after surviving COVID-19 infection and/or receiving COVID-19 vaccination (time frame: 2015-2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2022.