NCT06125457

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2022

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2023

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

December 19, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

September 1, 2022

Last Update Submit

December 12, 2023

Conditions

Keywords

COVID-19IgA deficiencyAntibiotic therapyImmunosuppressive treatmentsAutoimmune manifestationsNeoplasia

Outcome Measures

Primary Outcomes (1)

  • Positive test result for covid-19

    1 hour after hospitalization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Major subject (≥18 years old) with a primary selective IgA deficiency treated at the HUS from 01/01/2005 to 01/31/2022

You may qualify if:

  • 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.

You may not qualify if:

  • Subject who expressed their opposition to participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Immunologie Clinique - Médecine Interne - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

COVID-19IgA DeficiencyNeoplasms

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDysgammaglobulinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2022

First Posted

November 9, 2023

Study Start

April 9, 2022

Primary Completion

December 9, 2023

Study Completion

December 31, 2023

Last Updated

December 19, 2023

Record last verified: 2023-09

Locations