EUCTR2020-001888-90-DK进行中（未招募）1 期
sing BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic. A randomised controlled multi-center trial. - BCG-DENMARK-COVID
niversity of Southern Denmark0 个研究点目标入组 1,500 人开始时间: 2020年4月16日最近更新:
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
- 1,500
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 years); Hospital personnel working at one of the participating hospitals.
- •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 1400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration; Known active or latent infection with Mycobacterium tuberculosis (M. tuberculosis) or other mycobacterial species; Previous M. tuberculosis infection; Previous confirmed COVID-19 infection; Fever (>38 C) within the past 24 hours; Suspicion of active viral or bacterial infection; Pregnancy; Breastfeeding; Vaccination with other live attenuated vaccine within the last 4 weeks; Severely immunocompromised subjects. This exclusion category comprises a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) subjects with solid organ transplantation; c) subjects with bone marrow transplantation; d) subjects under chemotherapy; e) subjects with primary immunodeficiency; f) treatment with any anti-cytokine therapies. g) 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; Direct involvement in the design or the execution of the BCG-DENMARK-COVID study; Employed to the hospital < 22 hours per week.
研究者
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