Status:
UNKNOWN
Effectiveness and Safety of COVID-19 Vaccine in Patients With IBD Treated With Immunomodulatory or Biological Drugs (ESCAPE-IBD)
Lead Sponsor:
Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18+ years
Brief Summary
The COVID-19 pandemic has led to initial concerns for patients with Inflammatory Bowel Disease treated with immunosuppressive drugs, as they could be theoretically exposed to a higher risk of SARS-CoV...
Detailed Description
This is a 12-month, prospective, multicentre, case-control, observational study comparing effectiveness and safety of COVID-19 vaccine in patients with IBD treated with immunomodulatory drugs (cases) ...
Eligibility Criteria
Inclusion
- Patients of either sex, without racial restriction, aged 18 years or older, willing to receive the COVID-19 vaccine
- An established diagnosis of Crohn's disease or Ulcerative Colitis or unclassified colitis
- Current treatment with conventional immunosuppressants (steroids, azathioprine, 6-mercaptopurine, methotrexate), biologics (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab), or small molecule drugs (tofacitinib): will be included as cases
- Currently off-therapy or treated with mesalamine only: will be included as controls
- Capability to express a written informed consent for COVID-19 vaccination
- Capability to express a written informed consent for the study
Exclusion
- Primary immunodeficiencies and human immunodeficiency virus infection
- Vaccination against SARS-CoV-2 already performed before enrolment
- Contraindications to COVID-19 vaccine or intolerance to its components
- Documented history of previous occurrence of COVID-19
- Documented history of previous occurrence of asymptomatic SARS-CoV2 infection
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
1380 Patients enrolled
Trial Details
Trial ID
NCT04769258
Start Date
March 1 2021
End Date
June 1 2022
Last Update
February 24 2021
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