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Description of a Cohort of Covid-19 Patients With a Circulating Anticoagulant (LA-COVID)

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ClinicalTrials.gov Identifier: NCT05075928
Recruitment Status : Recruiting
First Posted : October 13, 2021
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.

Condition or disease
SARS-COV-2

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Description of a Cohort of Covid-19 Patients With a Circulating Anticoagulant
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners




Primary Outcome Measures :
  1. Retrospective study of thrombotic complications in a cohort of COVID patients with a circulating anticoagulant [ Time Frame: Files analysed retrospectively from March 01, 2020 to May 31, 2019 will be examined] ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-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
Criteria

Inclusion criteria:

  • 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

Exclusion criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05075928


Contacts
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Contact: Anne-Sophie Korganow, MD, PhD 33 3 69 55 05 21 Anne-sophie.Korganow@chru-strasbourg.fr
Contact: Saïd CHAYER, PhD, HDR said.chayer@chru-strasbourg.fr

Locations
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France
Service de Médecine Interne et d'Immunologie Clinique - Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Anne-Sophie Korganow, MD, PhD    33 3 69 55 05 21    Anne-sophie.Korganow@chru-strasbourg.fr   
Contact: Saïd CHAYER, PhD, HDR       said.chayer@chru-strasbourg.fr   
Principal Investigator: Anne-Sophie Korganow, MD, PhD         
Sub-Investigator: Olivier VOLLMER, MD         
Sub-Investigator: Yannick DIEUDONNE, MD         
Sub-Investigator: Lélia GRUNEBAUM         
Sub-Investigator: Nicolas MEYER         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Anne-Sophie Korganow, MD, PhD Service de Médecine Interne et d'Immunologie Clinique - Hôpitaux Universitaires de Strasbourg
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT05075928    
Other Study ID Numbers: 7861
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
SARS-COV-2
Covid-19
Antiphospholipid syndrome (APS)
autoimmune disease
antiphospholipid antibodies (aPL)
thrombosis
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases