NCT05075928

Brief Summary

SARS-COV-2 infection is responsible for a potentially severe primarily respiratory infection called COVID19. A large proportion of patients, in particular in severe forms, present with thrombotic manifestations (DVT, EP, stroke, thrombosis of dialysis circuits, etc.). A significant proportion is also a carrier of circulating anticoagulant (ACC or LA), making it possible to suggest a diagnosis of APS. This type of autoantibody results in a spontaneous prolongation of the TCA uncorrected by a control serum therefore is quickly diagnosed using standard hemostasis The objective of this study is to describe the diagnosis of thrombotic complications in COVID19 patients presenting a positive lupus anticoagulant type test (LA) or aPL and the associated clinical and biological elements that may have favored thrombosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 13, 2021

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

December 1, 2021

Status Verified

October 1, 2021

Enrollment Period

1.4 years

First QC Date

October 6, 2021

Last Update Submit

November 18, 2021

Conditions

Keywords

SARS-COV-2Covid-19Antiphospholipid syndrome (APS)autoimmune diseaseantiphospholipid antibodies (aPL)thrombosis

Outcome Measures

Primary Outcomes (1)

  • Retrospective study of thrombotic complications in a cohort of COVID patients with a circulating anticoagulant

    Files analysed retrospectively from March 01, 2020 to May 31, 2019 will be examined]

Eligibility Criteria

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

Major patient infected with Covid-19, with a documented infection, having presented a documented thrombosis (arterial or venous), with an LA or aPL in the thrombosis assessment

You may qualify if:

  • Adult patient (≥18 years old)
  • Patient taken care of in the SMO pole or the NHC surgical resuscitation service or hospitalized or consultant to the HUS between 01/03/2020 and 31/05/2020
  • Patient infected with Covid-19, with a documented infection, having presented a documented thrombosis (arterial or venous), with an LA or aPL in the thrombosis assessment
  • or Patient infected with Covid-19, with a documented infection, without documented thrombosis (arterial or venous), with in the standard work-up an increase in TCA revealing the presence of LA
  • Subject having given his agreement for the reuse of his data for the purposes of this research

You may not qualify if:

  • Subject having expressed opposition to participating in the study
  • Subject under guardianship or guardianship
  • Subject under safeguard of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Médecine Interne et d'Immunologie Clinique - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

COVID-19Antiphospholipid SyndromeAutoimmune DiseasesThrombosis

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesImmune System DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Anne-Sophie Korganow, MD, PhD

    Service de Médecine Interne et d'Immunologie Clinique - Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saïd CHAYER, PhD, HDR

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2021

First Posted

October 13, 2021

Study Start

June 1, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

December 1, 2021

Record last verified: 2021-10

Locations