NL-OMON27106尚未招募不适用
REDUCING HEALTH CARE WORKERS ABSENTEEISM IN SARS-CoV-2 PANDEMIC BY ENHANCED TRAINED IMMUNE RESPONSES THROUGH BACILLUS CALMETTE-GUÉRIN VACCINATION, A RANDOMIZED CONTROLLED TRIA
niversity Medical Centre 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
- 不适用
- 状态
- 尚未招募
- 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
入排标准
入选标准
- •Adult (=18 years);
- •- Male or female;
- •- Hospital personnel (expected to) 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 infection;
- •- Fever (>38 C) within the past 24 hours
- •- Pregnancy;
- •- Suspicion of active viral or bacterial infection;
- •- Vaccination in the past 4 weeks or expected vaccination during the study period, independent of the type of vaccination
- •- 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 < 22 hours per week;
- •- Not in possession of a smartphone
研究者
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