EpIgA: Epidemiology of IgA Selective Deficiency - Clinical Manifestations and Risk of Transmission

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT06125457

Collaborator

(none)

120

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The management of patients with a selective IgA deficiency currently consists of symptomatic treatment with treatment of infections by occasional or prolonged antibiotic therapy, immunosuppressive treatments for autoimmune pathologies, symptomatic treatment of allergic manifestations.

IVIG supplements are sometimes proposed in the event of recurrent infections and the demonstration of deficiencies in IgG subclasses (IgG1, 2, 3) often not sought for diagnosis The factors associated with the severity of clinical manifestations are not well identified and patients with IgA deficiency must be monitored over the long term because of the risk of the appearance of autoimmune manifestations and neoplasia. The identification of such factors could lead to the proposal of close monitoring for these patients.

IgA deficiency, which is frequent, has not been identified as a risk factor for severe COVID-19 infection, probably due to a lack of studies with sufficient recruitment. The therapeutic attitude concerning patients with an IgA deficiency in the event of COVID-19 infection is therefore not consensual.

There is currently no action to be taken regarding the risk of transmission of IgA deficiency.

Condition or Disease	Intervention/Treatment	Phase
COVID-19

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Epidemiology of IgA Selective Deficiency - Clinical Manifestations and Risk of Transmission: A Retrospective Cohort Study in Strasbourg University Hospital

Actual Study Start Date :

Apr 9, 2022

Anticipated Primary Completion Date :

Dec 9, 2023

Anticipated Study Completion Date :

Dec 9, 2023

Outcome Measures

Primary Outcome Measures

Positive test result for covid-19 [Files analysed retrospectively from January 01, 2005 to December 31, 2022 will be examined]
This is a retrospective study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Major subject (≥18 years old)
Subject treated at the HUS, with a primary selective IgA deficiency, considered as definitive (IgA concentration < 0.07g/L or total absence of IgA on immunofixation) or as probable (IgA concentration lower than two standard leads to standard for age) with no other humoral immunodeficiency and no other cause of decreased gammaglobulins 01/01/2005 to 01/31/2022.
Subject having not expressed, after being informed, their opposition to the reuse of their data for the purposes of this research.