EUCTR2021-001459-15-AT进行中（未招募）1 期
Immune response to COVID-19 Vaccination in people with Diabetes Mellitus - COVAC-DM study - COVAC-DM
Medical University of Graz0 个研究点目标入组 161 人开始时间: 2021年3月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 161
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria for Diabetes Mellitus Cohort
- •-Age between 18 and 80 years, both inclusive
- •-Planned COVID-19 vaccination
- •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 %
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Exlcusion criteria for Diabetes Mellitus Cohort
- •-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 or chronic 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
研究者
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