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

Completed

• Conditions: IBD; COVID

• Registration Number: NCT04344249
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-03-30
• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-10
• Study First Posted: 2020-04-14
• Primary Completion: 2021-02-18
• Study Completion: 2021-02-18
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1109

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
demographic factors and severity of COVID-19 infection	through study completion, an average of 2 year	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 ....
Clinical factors and severity of COVID-19 infection	through study completion, an average of 2 year	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 ....
pharmacologic factors and severity of COVID-19 infection	through study completion, an average of 2 year	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.

Trial Locations

Locations (1)

Chu Nantes; 🇫🇷 Nantes, France