COVID-19EpIgANCT06125457
Epidemiology of IgA Selective Deficiency - Clinical Manifestations and Risk of Transmission
An observational study of COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- . Subject who expressed their opposition to participating in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Immunologie Clinique - Médecine Interne - CHU de Strasbourg - France
Strasbourg, 67091
Anne-Sophie KORGANOW, MD, PhD, 33 3 69 55 05 21, Anne-sophie.Korganow@chru-strasbourg.fr
Anne-Sophie KORGANOW, MD, PhD
About this study
Official title: Epidemiology of IgA Selective Deficiency - Clinical Manifestations and Risk of Transmission: A Retrospective Cohort Study in Strasbourg University Hospital
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.
Read more
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.
- Conditions
- COVID-19
- Keywords
- COVID-19, IgA deficiency, Antibiotic therapy, Immunosuppressive treatments, Autoimmune manifestations, Neoplasia
- Medical subject headings
- COVID-19, IgA Deficiency, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive test result for covid-19
Measured: 1 hour after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start9 Apr 2022
- Primary completion9 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125457
- Sponsor's protocol ID
- 8587
- Acronym
- EpIgA
- Status last verified
- Sep 2023
- First submitted
- 1 Sep 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of IgA Selective Deficiency - Clinical Manifestations and Risk of Transmission: A Retrospective Cohort Study in Strasbourg University Hospital
- ClinicalTrials.gov ID
- NCT06125457
- Acronym / sponsor ID
- EpIgA / 8587
- Conditions
- COVID-19
- Keywords
- COVID-19, IgA deficiency, Antibiotic therapy, Immunosuppressive treatments, Autoimmune manifestations, Neoplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 9 Apr 2022 (actual)
- Primary completion
- 9 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- . Subject who expressed their opposition to participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive test result for covid-19
Time frame: 1 hour after hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Sophie KORGANOW, MD, PhD (33 3 69 55 05 21, Anne-sophie.Korganow@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive test result for covid-19 (time frame: 1 hour after hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.