NL-OMON55140已完成3 期
BCG vaccination to Reduce the impact of COVID-19 in healthcare workers (BRACE) Trial - BRACE
niversitair Medisch Centrum Utrecht0 个研究点目标入组 545 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 545
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Over 18 years of age
- •Healthcare worker. This is defined as anyone who works in a healthcare
- •setting or has face to face contact with patients.
- •Provide a signed and dated informed consent form
- •Pre-randomisation blood collected
排除标准
- •1 Has any BCG vaccine contraindication
- •o Fever or generalised skin infection (where feasible, randomisation can be
- •delayed until cleared)
- •o Weakened resistance toward infections due to a disease in/of the immune
- •o People with any serious underlying illness (such as malignancy)
- •o Known or suspected HIV infection,11 even if they are asymptomatic or have
- •normal immune function.
- •o People with active skin disease such as eczema, dermatitis or psoriasis at or
- •near the site of vaccination
- •o Another live vaccine administered in the month prior to randomisation
- •o Require another live vaccine to be administered within the month following
- •BCG randomisation
- •o Known anaphylactic reaction to any of the ingredient present in the BCG
- •o Previous active TB disease
- •o Currently receiving long term (more than 1 month) treatment with isoniazid,
- •rifampicin or quinolone as these antibiotics have activity against
- •Mycobacterium bovis
- •2 Previous adverse reaction to BCG vaccine (significant local reaction
- •(abscess) or suppurative lymphadenitis)
- •3 BCG vaccine given within the last year
- •4 Have 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)
- •5 Already part of this trial, recruited at a different hospital.
- •6 Participation in another COVID-19 prevention trial
- •7 Have previously received a COVID-19 specific vaccine
研究者
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