CTRI/2022/04/041882招募中4 期
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.
ICMR0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •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
排除标准
- •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)
研究者
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