EUCTR2020-000919-69-NL进行中（未招募）1 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 (COVID-19). - BCG-CORONA
niversity Medical Center0 个研究点目标入组 1,000 人开始时间: 2020年3月17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
- 1,000
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
- •In order to be eligible to participate in this study, a subject must meet the following criteria:
- •Adult (=18 years)
- •Male or female
- •Hospital personnel (expected to) taking care for patients with SARS-CoV-2 infection
- •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 1000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •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
- •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
相似试验
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.COVID-19SARS-CoV-210047438NL-OMON49761niversitair Medisch Centrum Utrecht1,500
尚未招募
不适用
BCG vaccination for healthcare workers in SARS-CoV-2 pandemicSARS-CoV-2, COVID19NL-OMON27106niversity Medical Centre Utrecht1,500
进行中（未招募）
1 期
BCG vaccination against COVID-19 infection in HungaryEUCTR2020-001783-28-HUational Korányi Institute of Pulmonology1,000
已完成
3 期
Reducing Health Care Workers Absenteeism in Covid-19 Pandemic Through BCG VaccineCOVID-19NCT04328441UMC Utrecht1,511
招募中
不适用
Prevention of Health Care Workers* Health Problems after Work Related Critical Incidents: A Randomized Controlled Trialburnoutacute stresstraumatic stress / long-term exhaustionvital exhaustion10002861NL-OMON33841Erasmus MC, Universitair Medisch Centrum Rotterdam180