Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT04769258
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04769258
Study Brief:
Protocol Section:
NCT04769258