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Completed

NCT Number: NCT04344249

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

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

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Key information

Conditions

IBD COVID Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Nantes

Nantes, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. IgG and IgM anti SARS-CoV-2

    Time frame: through study completion, an average of 2 year

    Impact of antibodies du to immunosuppressive protocol on the risk of viral infection

Secondary outcomes

  1. Clinical factors and severity of COVID-19 infection

    Time frame: 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 ....

  2. demographic factors and severity of COVID-19 infection

    Time frame: 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 ....

  3. pharmacologic factors and severity of COVID-19 infection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: IBD-COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 14, 2020
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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