EUCTR2020-002456-21-NL进行中(未招募)1 期
Enhancing the BCG-induced trained immunity response by addition of bisphosphonate or MMR vaccine: a possible preventive approach against COVID-19 (BCG-PLUS) - BCG-PLUS
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
- Radboudumc
- 入组人数
- 100
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
- •Adult (18-50 years of age);
- •Male or female;
- •Written informed consent
- •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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known allergy to (components of), or any other contraindication to, the BCG vaccine, MMR vaccine, or alendronic acid.
- •Known (history of) active or latent Mycobacterium tuberculosis or with another mycobacterial species;
- •Prior BCG vaccination;
- •Acute illness 2 weeks prior to the study or (suspicion of) active infection;
- •Pregnancy;
- •Chronic use of any systemic drugs other than oral contraceptives;
- •Use of NSAIDs less than 4 weeks prior to start of the study;
- •Vaccination in the past 3 months or expected vaccination during the study period, independent of the type of vaccination;
- •Medical history associated with immunodeficiency;
- •Active solid or non- solid malignancy within the prior two years;
- •Hypocalcemia;
- •Inability to sit upright for 30 minutes;
- •Esophagus abnormalities
研究者
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