Trial Details

Recruiting
Basic Information
Clinical ID c2305
Identifier CTRI/2022/04/041882
Trial Title Evaluation of efficacy and safety of SARS-CoV-2 vaccine in a registry of patients with Inflammatory Bowel Disease (IBD) a proof of concept study.
Trial URL Visit Original Page
Study Information
Study Results

False

Conditions clinical judgement is will not affect the SARS-CoV-2 vaccine efficacy and safety _
Interventions Exclusion criteria: 1) Patients taking any Immunomodulator and/or immunosuppressant and/or corticosteroids for diseases other than IBD. _ 2) IBD patients with major significant comorbidity chronic kidney disease, congestive heart failure, malignancy). _ 3) Major illness which is likely to impact vaccine outcome in the opinion of Principal Investigator (E.g.: Cirrhosis, malabsorption syndrome, severe malnutrition, short bowel syndrome, etc) _ 4) History of HIV and Hep B positive serology based on previous reports _ 5) Patients who are vaccine hesitant (In patients who are yet unvaccinated) _ 6) Patients in whom COVID-19 vaccine is contraindicated i.e food allergy, drug allergy as per Government of India Guidelines (In patients who are yet unvaccinated) _ 7) Patients whose both doses of COVID-19 vaccine have been completed 6 months prior to the enrolment (In patients who have received both doses of the vaccine) _ _
Participant Information
Sponsor ICMR
City -
Country/Region India
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Observational
Phase PHASE4
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -