NCT05313048

Brief Summary

Prospective observational study to evaluate a possible change in APS antibody profiles after COVID-19 infection or vaccination

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2022

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

April 5, 2022

Last Update Submit

December 20, 2022

Conditions

Antiphospholipid SyndromeCOVID-19 InfectionCOVID-19 Vaccination

Outcome Measures

Primary Outcomes (1)

  • 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.

    2015-2022

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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)

You may qualify if:

  • 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

You may not qualify if:

  • APS with isolated pregnancy complications
  • No anticoagulation medication
  • Inadequately diagnosed APS
  • Non-compliance on the part of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardioangiology Center Bethanien (CCB)

Frankfurt am Main, 60389, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

frozen citrated plasma samples

MeSH Terms

Conditions

Antiphospholipid SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Edelgard Lindhoff-Last, Prof. MD

    Cardioangiology Center Bethanien

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 6, 2022

Study Start

March 15, 2022

Primary Completion

October 24, 2022

Study Completion

October 24, 2022

Last Updated

December 21, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)