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

COVID Clinical Trial

— IBD-COVID-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04344249
• Other study ID #: RC20_0150
• Status: Completed
• Start date: March 30, 2020
• Est. completion date: February 18, 2021

Study information

• Verified date: March 2024
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1109
• Est. completion date: February 18, 2021
• Est. primary completion date: February 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID
• COVID-19
• IBD
• Inflammatory Bowel Diseases

Locations

Country	Name	City	State
France	Chu Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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