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临床试验/EUCTR2020-002456-21-NL
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

Radboudumc0 个研究点目标入组 100 人开始时间: 2020年5月26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
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

发起方
Radboudumc

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