Application of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID-19
试验速览
- 阶段
- 3 期
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- incidence of confirmed COVID-19
研究概览
简要总结
Phase III Placebo-controlled adaptive multi-centre randomized controlled trial Interventional (Clinical Trial). The study will include nine hundred healthcare workers in the isolation hospitals for COVID-19 cases; they will be randomly assigned to receive either BCG vaccine or normal saline.
详细描述
Nine hundred healthcare workers will be randomly assigned to receive intradermal injection of either BCG vaccine or normal saline.
During the study:
- Mantoux Tuberculin skin testing (will be done prior to administration of the BCG vaccine in the first group by intradermally injecting 0.1 mL of liquid containing 5 TU (tuberculin units) of purified protein derivative (PPD) in the volar aspect of the left forearm. The test is being read after 48-72 hrs. A positive tuberculin test is defined as induration ≥10 mm.
- Participants will be assessed clinically on daily basis for COVID 19 infection in the form of: fever, dry cough, fatigue, & dyspnea.
- PCR sampling for COVID-19 will be withdrawn for all participants at the end of the study.
- The duration of follow-up for each participant depends on the interim results of the primary endpoint and the probability of obtaining a result, with a maximum of 6 months.
Randomization method:
A block-randomization scheme will be generated by computer software. Participants will be randomized between 0.10 mL intradermal injection of BCG vaccine or placebo normal saline in a 2:1 ratio (600 will receive BCG & 300 will receive placebo saline). In Egypt, the available BCG vaccine is the Copenhagen (Danish strain).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy healthcare workers defined as nurses and physicians working at emergency rooms, ICUs, and wards of isolation hospitals
排除标准
- •Immunosuppression
- •Pregnancy & lactation
- •Chronic underlying medical illness
- •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.
- •Fever (>38 C) within the past 24 hours
- •Current bacterial infection
- •Recent viral infection
- •Refusal of doing tuberculin test in the first group
结局指标
主要结局
incidence of confirmed COVID-19
时间窗: 9 months
Estimate the incidence of confirmed COVID-19 among the healthcare workers in isolation hospitals
Effectiveness of BCG vaccine
时间窗: 9 months
Evaluate the effectiveness of BCG vaccine in protecting the healthcare workers in isolation hospitals against the risk of COVID-19 infection by detecting any positive cases among vaccinated healthscare workers
次要结局
未报告次要终点
研究者
Adel Khattab
Professor of chest Faculty of Medicine Ain Shams University
Ain Shams University