BCG Vaccine to Reduce Unplanned Absenteeism Due to Illness of Health Care Workers During the COVID-19 Pandemic. A Multi-center Randomised Controlled Trial (BCG-COVID-RCT)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 668
- 试验地点
- 4
- 主要终点
- Days of unplanned absenteeism due to illness
研究概览
简要总结
The COVID-19 pandemic challenges available hospital capacity. Strategies to protect health care workers (HCW) are desperately needed. Bacille Calmette- Guérin (BCG) has protective non-specific effects against other infections; a plausible immunological mechanism has been identified in terms of "trained innate immunity".
The primary objective of the study is to evaluate whether BCG can reduce unplanned absenteeism due to illness among HCW during the COVID-19 pandemic. Secondary objectives are to reduce the number of HCW that are infected with COVID-19, reduce hospital admissions for HCW and to improve the capacity for clinical research.
Design: Single-blind, parallel-group placebo-controlled multi-centre block randomized trial including a total of 1050 HCW. The study sites will be the Manhiça hospital in Mozambique, Central Hospital Dr. Agostinho Neto and Central Hospital Dr. Baptista de Sousa in Cape Verde and Hospital Nacional Simão Mendes and other hospitals in the capital Bissau in Guinea-Bissau. Population: HCW (nurses/physicians/others) ≥18 years.
Intervention: Block randomization 1:1 to intradermal standard dose (0.1 ml) of BCG vaccine or placebo (saline). Endpoints: Primary: Days of unplanned absenteeism due to illness. Secondary: Days of absenteeism because of documented COVID-19; cumulative incidence of infectious disease hospitalizations.
Follow-up: mobile phone interviews every second week, regarding symptoms, absenteeism and causes, COVID-19 testing (if done) and their results.
Perspectives: If BCG can reduce HCW absenteeism it has global implications. The intervention can quickly be scaled up all over the world.
详细描述
The main hypothesis for this study is that BCG vaccination of HCW reduces unplanned absenteeism due to illness by 20%.
Trial design Single-blind, parallel-group placebo-controlled adaptive multicentre trial, with block-randomisation 1:1 (treatment:placebo) in blocks of 20 within strata defined by gender (male/female) and occupational group (doctors/ nurses/other) to an intradermal standard 0.1 ml dose of BCG vaccine or placebo (saline) including a total of 1050 HCW (BCG arm and placebo arm).
Study population:
Health Care Workers defined as a person who delivers care and services to the sick and ailing either directly as doctors and nurses or indirectly as aides, helpers, laboratory technicians, or even medical waste handlers.
Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded to treatment. The physicians administering the BCG vaccine or placebo will not be blinded. Those assessing outcomes will be blinded to the randomization allocation. In case of serious adverse events, the participant can be unblinded after consultation with the coordinating PI or sponsor.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •health care worker (physician, nurse, or other) based at one of the research hospitals.
- •age ≥18 years
排除标准
- •known allergy to (components of) BCG or serious adverse events to prior BCG administration;
- •known previous, active or latent infection with Mycobacterium tuberculosis or other mycobacterial species
- •fever (>38 C) within past 24 hours;
- •previous confirmed COVID-19 (positive test - PCR or antibody);
- •suspicion of active viral or bacterial infection
- •severely immunocompromised subjects
- •self-reported HIV infection
- •self-reported pregnancy;
- •active solid or non-solid malignancy or lymphoma within the prior two years;
- •contraindications for live attenuated vaccine administration.
- •not having a mobile phone.
结局指标
主要结局
Days of unplanned absenteeism due to illness
时间窗: 6 months after inclusion
Unplanned absenteeism is defined by being absent from work due to causes other than holidays, parental leave, and other planned leaves, family assistance (including mourning leave) and quarantine measures.
次要结局
- Death(6 months after inclusion)
- Days of unplanned absenteeism due to documented COVID-19(6 months after inclusion)
- Cumulative incidence of hospital admissions due to illness (minus accidents).(6 months after inclusion)