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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04344249

Acronym

IBD-COVID-19

Enrollment

1109

Registered

2020-04-14

Start date

2020-03-30

Completion date

2021-02-18

Last updated

2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID, IBD

Keywords

IBD, Ulcerative colitis, SARS-CoV-2, infliximab, vedolizumab, Crohn's disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 ....
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 ....
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.

Countries

France

Outcome results