EUCTR2020-002503-19-NL进行中（未招募）1 期
BCG vaccination to Reduce the impact of COVID-19 in healthcare workers (BRACE) Trial - BRACE
MC Utrecht0 个研究点目标入组 10,000 人开始时间: 2020年6月5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
- 10,000
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
- •Over 18 years of age
- •Healthcare worker
- •Provide a signed and dated informed consent form
- •Pre-randomisation blood collected
- •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 10000
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1Has any BCG vaccine contraindication
- •oFever or generalised skin infection (where feasible, randomisation can be delayed until cleared)
- •oWeakened resistance toward infections due to a disease in/of the immune system
- •oPeople with any serious underlying illness (such as malignancy)
- •oKnown or suspected HIV infection,11 even if they are asymptomatic or have normal immune function.
- •oPeople with active skin disease such as eczema, dermatitis or psoriasis at or near the site of vaccination
- •oAnother live vaccine administered in the month prior to randomisation
- •oRequire another live vaccine to be administered within the month following BCG randomisation
- •oKnown anaphylactic reaction to any of the ingredient present in the BCG vaccine
- •oPrevious active TB disease
- •oCurrently receiving long term (more than 1 month) treatment with isoniazid, rifampicin or quinolone as these antibiotics have activity against Mycobacterium bovis
- •2Previous adverse reaction to BCG vaccine (significant local reaction (abscess) or suppurative lymphadenitis)
- •3BCG vaccine given within the last year
- •4Have previously had a SARS-CoV-2 positive test result (positive PCR on a respiratory sample or a positive SARS-CoV-2 diagnostic antigen test approved by the local jurisdiction’s public health policy
- •5Already part of this trial, recruited at a different hospital.
- •6Participation in another COVID-19 prevention trial
- •7Have previously received a COVID-19 specific vaccine
研究者
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