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

March 7, 2024 updated by: Nantes University Hospital

Prospective Multicenter Cohort of Patients With Inflammatory Bowel Disease Treated by Infliximab or Vedolizumab 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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nantes, France
        • CHU Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

all adult patients with Crohn's disease or ulcerative colitis treated by infliximab or vedolizumab

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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 ....
through study completion, an average of 2 year
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 ....
through study completion, an average of 2 year
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.
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2020

Primary Completion (Actual)

February 18, 2021

Study Completion (Actual)

February 18, 2021

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC20_0150

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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