EUCTR2020-003470-47-NL进行中（未招募）1 期
BACILLUS CALMETTE-GUÉRIN VACCINATION TO PREVENT SERIOUS RESPIRATORY TRACT INFECTION AND COVID-19 IN VULNERABLE ELDERLY – AN ADAPTIVE RANDOMIZED CONTROLLED TRIAL - BCG-PRIME
MCU Utrecht0 个研究点目标入组 5,200 人开始时间: 2020年9月26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
- 5,200
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
- •Age =60 years
- •Having a chronic somatic disease* or having undergone major surgery**
- •Meeting at least one of the following criteria:
- •a)Planned to be discharged from the hospital or discharged from the hospital less than 6 weeks ago; a hospital admission is defined as an overnight stay. Departments of interest are those that in the opinion of the principle investigator admit mostly vulnerable elderly and include but are not limited to: cardiology, pulmonology, internal medicine, neurology.
- •b)Visiting a medical outpatient clinic
- •c)Attending the thrombosis care service
- •* Chronic somatic diseases do not include risk factors such as hypertension or obesity
- •** Major surgery is any invasive operative procedure in which a more extensive resection is performed, e.g. a body cavity is entered, organs are removed, or normal anatomy is altered. In general, if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges), the surgery is considered major.
- •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 5500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5500
排除标准
- •Fever (>38 ºC) within the past 24 hours
- •Suspicion of current active viral or bacterial infection; the requirement to finish an antibiotic course upon discharge is not an exclusion criterion when the infection is controlled in the opinion of the attending physician
- •Vaccination with live vaccine in the past four weeks or planned vaccination with live vaccine during the next four weeks
- •Severely immunocompromised participants. This exclusion category comprises:
- •a)known infection by the human immunodeficiency virus (HIV-1);
- •b)neutropenic with less than 500 neutrophils/mm3;
- •c)solid organ transplantation;
- •d)bone marrow transplantation;
- •e)hematological malignancy;
- •f)chemo-, radio- or immunotherapy for solid organ malignancy in the past 6 months;
- •g)primary immunodeficiency;
- •h)severe lymphopenia with less than 400 lymphocytes/mm3;
- •i)treatment with any immunosuppressant drugs such as anti-cytokine therapies, and treatment with oral or intravenous steroids defined as daily doses of >10 mg/day or a cumulative dose of >700 mg prednisone or equivalent for other corticosteroids in the three months prior to enrolment, or probable use of oral or intravenous steroids in the following four weeks;
- •j)receiving chronic renal replacement therapy.
- •Known history of a positive Mantoux or active TB; prior BCG vaccination or a positive Mantoux test after BCG vaccination without confirmation of TB are NOT an exclusion criterion.
- •Born in a country with high incidence of TB (see supplement B)
- •Active participation in another research study that involves BCG administration
- •History of documented COVID-19 (self-reported by the participant: either confirmed by a microbiological test or with clinical diagnosis during hospitalization)
- •Not able to perform the study procedures as judged by the attending physician
- •Legally incapacitated or unwilling to provide informed consent
研究者
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