EUCTR2020-001678-31-FR进行中（未招募）1 期
Randomized controlled trial evaluating the efficacy of vaccination with Bacillus Calmette and Guérin (BCG) in the Prevention of COVID-19 via the strengthening of innate immunity in Health Care Workers.”COVID-BCG - COVID BCG
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,120
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
- •-Individual (Male and female) aged 18 or over.
- •-Healthcare Worker (medical or non-medical) from hospitals in direct -contact with COVID-19 patients.
- •-Participants must give their written consent before any trial procedure.
- •-Participants covered by social security regimen (excepting AME).
- •-Healthy according to the opinion of the investigator.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Has any BCG vaccine contraindication, known allergy to the BCG vaccine or SAE to prior BCG vaccination.
- •-History of tuberculosis
- •-People with acquired or innate immunodeficiency.
- •-People have already been infected with SARS Cov-2 (virological documentation or TDM or seropositive if serology available).
- •-People who could not commit to follow-up for 6 months.
- •-People not in good general condition, as assessed by the investigator.
- •-People included in other therapeutic clinical trials assessing treatment
- •-Pregnant or breastfeeding at enrolment visit.
- •-BCG vaccine given within the last year.
- •-Another live vaccine administered in the month prior to randomization.
- •-History of anaphylaxis following vaccination.
- •-Receiving medical treatment that affects the immune response or other immunosuppressive therapy in the last year. These therapies include systemic corticosteroids (more than or equal to 10 mg for more than or equal to 2 weeks), immunosuppressant, biological agents (such as monoclonal antibodies against tumour necrosis factor (TNF)-alpha).
- •-Another vaccine administered in the month prior to inclusion and randomization.
- •- Fever > 38°C within the past 24 hours
- •- People under legal protection measure (tutorship)
研究者
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