Autoantibodies neutralizing type I IFNs are present in ~4% of uninfected individuals over 70 years old and account for ~20% of COVID-19 deaths.
Paul Bastard, Adrian Gervais, Tom Le Voyer...
https://pubmed.ncbi.nlm.nih.gov/34413139Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID06762002
Impaired Type I IFN Immunity Due to Autoantibodies or a Genetic Defect: a Prospective National Cohort
Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2025-09-08
500
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a national, multicenter prospective study to understand how genetic defects and autoantibodies against type I interferons (IFNs) affect the immune response to infections, especially severe viral diseases like COVID-19. This study focuses on adults who either have inborn errors of immunity (IEI) impairing type I IFN responses or carry neutralizing autoantibodies against type I IFNs, which have been linked to severe illness and increased mortality in COVID-19. The aim is to track infectious, autoimmune, and cancer-related events to improve prevention and management strategies for these patients. The study includes adults with these immune characteristics who may be patients with past or current disease or healthy individuals such as blood donors or relatives of affected patients. Participants will have yearly visits to clinical centers for blood sampling and medical history updates, including investigations of immune markers, autoantibodies, and genetic analyses. Additional visits occur if participants experience infections, autoimmune flare-ups, cancer diagnoses, or COVID-19 infections, with detailed blood tests and teleconsultations. Controls without these immune abnormalities will be matched and followed through questionnaires and health data linkage. Participants undergo an initial visit to collect demographic information, medical and family history, and blood samples for detailed immune and genetic tests, including whole-exome or whole-genome sequencing. Follow-up visits occur annually for up to four years, involving clinical assessments and blood sampling to measure autoantibody levels and immune function. Clinical events and healthcare use will be tracked through national health data, and the main outcomes include measuring autoantibody levels and their neutralizing activity over time. This long-term monitoring aims to reveal factors influencing disease risk and immune changes in this population.
CONDITIONS
Brief Title
Impaired Type I IFN Immunity Due to Autoantibodies or a Genetic Defect: a Prospective National Cohort
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age >18 years
- History of carrying autoantibodies against type I interferons or having inborn errors of immunity impairing type I IFN response or production
- Affiliated to social security
- Signed informed consent
You will not qualify if you...
- Participation in an interventional clinical trial on pharmacological treatment
- Clinical condition leading to life expectancy less than 1 year
- Under legal protection measures such as safeguard of justice, curatorship, or tutorship
- Individuals deprived of freedom
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - At enrollment and annually for up to 3 years
Participants provide blood samples for a range of laboratory tests, including blood cell counts, autoimmune investigations, immunophenotyping, evaluation of autoantibodies against type I interferons, genetic explorations, and biobanking.
1 visit at enrollment and annual visits for 3 years
Long-term Monitoring
Duration - Up to 3 years
Participants are monitored for clinical events such as infections, autoimmune diseases, or cancers, along with clinical and biological factors influencing outcomes, over a period of up to 3 years.
Annual visits for up to 3 years
Trial Site Locations
Total: 9 locations
1
Cic Lille
Lille, France
Actively Recruiting
2
LYON HCL
Lyon, France
Actively Recruiting
3
Cic Montpellier
Montpellier, France
Actively Recruiting
4
Cic Bichat
Paris, France
Actively Recruiting
5
Cic Creteil
Paris, France
Actively Recruiting
6
Cic La Salpetriere
Paris, France
Actively Recruiting
7
Cic Necker
Paris, France
Actively Recruiting
8
Cic St Louis
Paris, France
Actively Recruiting
9
Cic Tours
Tours, France
Actively Recruiting
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Research Team
X
Xavier-Marie DUVAL, PU-PH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Inborn errors of type I IFN immunity in patients with life-threatening COVID-19.
Qian Zhang, Paul Bastard, Zhiyong Liu...
https://pubmed.ncbi.nlm.nih.gov/32972995Autoantibodies against type I IFNs in patients with life-threatening COVID-19.
Paul Bastard, Lindsey B Rosen, Qian Zhang...
https://pubmed.ncbi.nlm.nih.gov/32972996