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IMMUNOCOVID: Prevalence and Clinical Significance of Anti-annexin A2 Antibodies in COVID-19 Infection

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT05242159
Collaborator
(none)
300
Enrollment
1
Location
5.5
Anticipated Duration (Months)
54.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In January 2020, researchers isolated and sequenced in China from patients with severe atypical pneumonia a novel coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 has rapidly spread throughout the world. SARS-CoV-2 may trigger hyperstimulation of immune system with an autoinflammatory response but also the development of an autoimmune process. These autoimmune responses may also develop through the molecular mimicry between virus and human-self components. Multiple autoantibodies have been described in COVID-19 patients.

Annexin A2 (ANXA2), an endothelial cell receptor for plasminogen and tissue plasminogen activator has been identified as a new autoantigen in antiphospholipid syndrome. ANXA2 has been identified as candidate autoantigen recognized by SARS patient sera. ANXA2 contributes also to pulmonary microvascular integrity. These data lead to identify anti-ANXA2 antibodies in COVID-19 patient sera and to know if the presence of these antibodies is associated with pulmonary injury or thrombosis in COVID-19 and represents a marker of severity.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Prevalence and Clinical Significance of Anti-annexin A2 Antibodies in COVID-19 Infection
    Actual Study Start Date :
    Feb 15, 2022
    Anticipated Primary Completion Date :
    Aug 1, 2022
    Anticipated Study Completion Date :
    Aug 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of anti-ANXA2 antibodies in patients with COVID-19 infection [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 years and older

    • All patients hospitalized in Amiens University Hospital with COVID-19 infection

    Exclusion Criteria:

    • Autoimmune diseases

    • Chronic viral infection by hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV)

    • Immunosuppressive treatment

    • Solid tumors

    • Hematological malignancies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Amiens Amiens France 80054

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire, Amiens

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire, Amiens
    ClinicalTrials.gov Identifier:
    NCT05242159
    Other Study ID Numbers:
    • PI2021_843_0120
    First Posted:
    Feb 16, 2022
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire, Amiens
    COVID-19
    annexin A2
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Mar 4, 2022