DRKS00024879招募中不适用
Immune response and therapy assessment to COVID-19 Vaccinations in people with Diabetes Mellitus – an observational pilot study - COVACDIA
Division Exercise Physiology and Metabolism0 个研究点目标入组 60 人开始时间: 2021年6月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Planned COVID-19 vaccination(Each participant)
- •Cohort I (Diabetes mellitus Type 1, well controlled)
- •Glycated haemoglobin levels HbA1c =7.5 %
- •Cohort II (Diabetes mellitus Type 1, uncontrolled)
- •Glycated haemoglobin levels HbA1c >7.5 %
- •Cohort III (Diabetes mellitus Type 2, well controlled)
- •Glycated haemoglobin levels HbA1c =7.5 %
- •Cohort IV (Diabetes mellitus Type 2, uncontrolled)
- •Glycated haemoglobin levels HbA1c >7.5 %
排除标准
- •Active known malignancy within the last year excluding intraepithelial neoplasia of prostate, gastrointestinal tract and basalioma
- •Pregnancy or intention of becoming pregnant; breastfeeding
- •Immunosuppressive therapy
- •Acute inflammatory disorder
- •Alcohol abuse (more than 15 drinks / week)
- •Any contraindication to the vaccine planned to receive as listed in the product characteristics
- •Previous COVID-19 vaccine or episode of COVID-19
- •/ Healthy control group:
- •Presence of disease or therapies that are likely to interfere with the immune response to vaccination
- •Presence of a disease requiring change in therapy during 4 weeks prior to enrollment
- •Any contraindications to the vaccine planned to receive as listed in the product characteristics
- •Women who are pregnant, breastfeeding or not following adequate contraceptive measures
- •Previous vaccination with any coronavirus vaccine or episode of COVID-19
研究者
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