COVID-19 vaccination in patients of Inflammatory Bowel Disease

Phase 4

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: K50-K52- Noninfective enteritis and colitis

• Registration Number: CTRI/2022/04/041882
• Lead Sponsor: ICMR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Patients listed in IBD registry at Department of Medical Gastroenterology.

2) Patients of either gender of more than 18 years as per the Government of India guidelines of SARS-CoV-2 vaccination.

3) Patient on an immunomodulator and/or immunosuppressants and/or corticosteroids.

o(E.g ââ?¬â?? Sulfasalzine, mesalamine, osalazine, balsalazine, budesonide, 5-ASA, azathioprine, methotrexate, prednisolone, betamethasone, dexamethasone, infliximab, adalimumab, certolizumab pegol, tofactinib, filgotinib, leflunomide)

4) Patients willing to give written informed consent.

5) IBD patients without concomitant disease or with concomitant disease which as per investigatorââ?¬•s clinical judgement is will not affect the SARS-CoV-2 vaccine efficacy and safety

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified