Cohort of Patients With Inflammatory Bowel Disease During COVID-19 Pandemic

Study Overview
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Brief Summary
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Multicenter cohort of patients followed for 6 months during the pandemic in France with biocollection of sera and peripheral blood mononuclear cells

Detailed Description
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Multicenter cohort of patients followed for 6 months during the pandemic in France with biocollection of sera and peripheral blood mononuclear cellsNo data has been published concerning the incidence and prevalence of SARS-CoV-2 infection in patients with IBD and treated by IV infusion of infliximab or vedolizumab. It seems that biotherapies have a minimal impact on the severity of the viral infection but data are scarce. The objectives of the cohort are to quantify the incidence and the prevalence of SARS-CoV-2 in this population of patients, to determine clinical, demographic and biological factors associated with the risk of infection and the severity of the disease with a Multicenter cohort of patients followed for 6 months during the pandemic in France with biocollection of sera and peripheral blood mononuclear cells.

Official Title
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Prospective Multicenter Cohort of Patients With Inflammatory Bowel Disease Treated by Infliximab or Vedolizumab During COVID-19 Pandemic

Conditions
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IBD, COVID

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients (>18 years), know Crohn's disease or ulcerative colitis, treated by infliximab or vedolizumab Exclusion Criteria: not affiliated to a sanitary social insurance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgG and IgM anti SARS-CoV-2 | Impact of antibodies du to immunosuppressive protocol on the risk of viral infection | through study completion, an average of 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical factors and severity of COVID-19 infection | Describe clinical factors of the population of IBD patients treated with vedolizumab or infliximab who develop asymptomatic, pauci-symptomatic non-hospitalized and severe IBD requiring hospital management. weight (Kg) height (m) ABO Group .... | through study completion, an average of 2 year | 
| demographic factors and severity of COVID-19 infection | Describe demographic factors of the population of IBD patients treated with vedolizumab or infliximab who develop asymptomatic, pauci-symptomatic non-hospitalized and severe IBD requiring hospital management. ACCOMMODATION HOUSING AREA number of people at home .... | through study completion, an average of 2 year | 
| pharmacologic factors and severity of COVID-19 infection | Describe residual rates of treatments (edolizumab or infliximab) of the population of IBD patients who develop asymptomatic, pauci-symptomatic non-hospitalized and severe IBD requiring hospital management. | through study completion, an average of 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBD, Ulcerative colitis, SARS-CoV-2, infliximab, vedolizumab, Crohn's disease