NL-OMON49761已完成3 期
Reducing health care workers absenteeism in SARS-CoV-2 pandemic by enhanced trained immune responses through Bacillus Calmette-Guérin vaccination, a randomized controlled trial. - BCG-CORONA
niversitair Medisch Centrum Utrecht0 个研究点目标入组 1,500 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Adult (*18 years)
- •* Male or female
- •* Hospital personnel taking care for patients with SARS-CoV-2 infection
排除标准
- •* Known allergy to (components of) the BCG vaccine or serious adverse events to
- •prior BCG administration
- •* Known active or latent Mycobacterium tuberculosis or with another
- •mycobacterial species. A history with- or a suspicion of M. tuberculosis
- •* Fever (>38 C) within the past 24 hours
- •* Pregnancy
- •* Suspicion of active viral or bacterial infection
- •* Severely immunocompromised subjects. This exclusion category comprises: a)
- •subjects with known infection by the human immunodeficiency virus (HIV-1); b)
- •neutropenic subjects with less than 500 neutrophils/mm3; c) subjects with solid
- •organ transplantation; d) subjects with bone marrow transplantation; e)
- •subjects under chemotherapy; f) subjects with primary immunodeficiency; g)
- •severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any
- •anti-cytokine therapies. i)treatment with oral or intravenous steroids defined
- •as daily doses of 10mg prednisone or equivalent for longer than 3 months, or
- •probable use of oral or intravenous steroids in the following four weeks
- •* Active solid or non-solid malignancy or lymphoma within the prior two years
- •* Direct involvement in the design or the execution of the BCG-CORONA study
- •* Expected absence from work of *4 of the following 12 weeks due to any reason
- •(holidays, maternity leave, retirement, planned surgery etc)
- •* Employed to the hospital less than 22 hours per week
- •* Not in possession of a smartphone
- •* Vaccination in the past 4 weeks or expected vaccination during the study
- •period, independent of the type of vaccination.
研究者
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