EUCTR2021-001391-42-AT进行中（未招募）1 期
Characterisation of the effects of Spermidine on the immune response to Covid-19 vaccine in older people - a feasibility study - Spermidine and Covid-19 vaccination in older people
Medical University of Graz0 个研究点目标入组 40 人开始时间: 2021年4月13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
- 40
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
- •1.Capacity to provide written informed consent
- •2.Age =65 and <90 years at consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Incapacity to provide written informed consent
- •2.Active signs or symptoms of acute infection at the time of screening
- •3.Ongoing or previous SARS-CoV-2 vaccination
- •4.Positive SARS-CoV-2 PCR in the past or during the study period.
- •5.Glucocorticoid, immunosuppressive or other immune modifying therapy, current or within 3 months prior to first study visit
- •6.Medical history of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
- •7.Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation, current or within 3 months prior to first study intervention
- •8.Medical conditions that can suppress the immune system
- •9.Any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct.
- •10.History of liver insufficiency or laboratory evidence of liver dysfunction with aspartate transaminase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal
- •11.Previous allergy to vaccinations or their constituent parts
- •12.History of malignancies other than skin
- •13.Hypersensitivity to Spermidine or to any of its excipients
- •14.Gluten intolerance
- •15.Contraindication to vaccination
- •16.Use of any other investigational drug in the previous 30 days and/or intent on using any investigational drug for the duration of the trial
- •17.Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results
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