EUCTR2020-003904-15-DK进行中（未招募）1 期
sing BCG vaccine to enhance non-specific protection of senior citizens during the COVID-19 pandemic. A randomized clinical trial. - BCG-DENMARK-SENIOR
niversity of Southern Denmark0 个研究点目标入组 1,900 人开始时间: 2020年8月11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
- 1,900
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
- •In order to be eligible to participate in this study, a subject must meet the following criteria: =65 years old.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1900
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Known allergy to (components of) the BCG vaccine or serious adverse events in relation to prior BCG administration
- •Previous Mycobacterium tuberculosis (M. tuberculosis) infection or known active or latent infection with M. tuberculosis or other mycobacterial species
- •Previous confirmed COVID-19 infection
- •Fever (>38 C) within the past 24 hours or suspicion of active viral or bacterial infection
- •Vaccination with other live attenuated vaccine within the last 4 weeks
- •Subjects who do not have access to e-Boks
- •Severely immunocompromised subjects. This exclusion category comprises:
- •Subjects with known infection with human immunodeficiency virus (HIV)
- •Subjects with solid organ transplantation or bone marrow transplantation
- •Subjects under chemotherapy
- •Subjects with primary immunodeficiency
- •Treatment with any anti-cytokine therapy within the last year
- •Treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months
- •Active solid or non-solid malignancy or lymphoma within the prior two years
研究者
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