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Trial Title:
Epidemiology of IgA Selective Deficiency - Clinical Manifestations and Risk of Transmission
NCT ID:
NCT06125457
Condition:
COVID-19
Conditions: Official terms:
COVID-19
Conditions: Keywords:
COVID-19
IgA deficiency
Antibiotic therapy
Immunosuppressive treatments
Autoimmune manifestations
Neoplasia
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
Major subject (≥18 years old) with a primary selective IgA deficiency treated at the HUS
from 01/01/2005 to 01/31/2022
Sampling method:
Non-Probability Sample
Criteria:
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.
Exclusion criteria:
. Subject who expressed their opposition to participating in the study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Service d'Immunologie Clinique - Médecine Interne - CHU de Strasbourg - France
Address:
City:
Strasbourg
Zip:
67091
Country:
France
Status:
Recruiting
Contact:
Last name:
Anne-Sophie KORGANOW, MD, PhD
Phone:
33 3 69 55 05 21
Email:
Anne-sophie.Korganow@chru-strasbourg.fr
Investigator:
Last name:
Anne-Sophie KORGANOW, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Olivier VOLLMER, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jeanne MALLICK, MD
Email:
Sub-Investigator
Investigator:
Last name:
Isabelle JAHN
Email:
Sub-Investigator
Start date:
April 9, 2022
Completion date:
December 31, 2023
Lead sponsor:
Agency:
University Hospital, Strasbourg, France
Agency class:
Other
Source:
University Hospital, Strasbourg, France
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06125457
