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NCT05242159 Clinical Trial

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

COVID-19 Clinical Trial

— IMMUNOCOVID  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05242159
Other study ID # PI2021_843_0120
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 15, 2022
Est. completion date August 2023

Study information
Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Valéry Salle, MD
Phone 03 22 66 82 30
Email salle.valery@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date August 2023
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU Amiens Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of anti-ANXA2 antibodies in patients with COVID-19 infection 6 months
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