Clinical Trial of COVID-19 Therapeutic Vaccine Formulated as an Oral Pill
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Effect on biochemistry parameters as per CTCAE v4.0
研究概览
简要总结
Safety and immunogenicity one-month study in healthy individuals administered once-daily pill of therapeutic vaccine made from heat-inactivated plasma from donors with COVID-19. Healthy, at least 20, volunteers will be monitored for signs of adverse events. Their PBMC will be collected at baseline and one month later to analyze which type of immune response vaccine has induced.
详细描述
Experimental batch of tableted thermostable vaccine obtained from pooled plasma of COVID-19 patients is produced. The goal of this trial is test safety and immunogenicity of once-per-day day administered orally to volunteers for 15 days. Baseline and post-treatment standard safety parameters will be compared. Blood samples from volunteers will be monitored and immunogenicity lab assays will be undertaken to characterize immune response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed cases of Covid-19 (all by RT-PCR from same laboratory)
- •Mild to severe clinical presentation (identified at the time of admission to ward by National Early Warning Score NEWS-2; mild 0-4; severe 5-6)
排除标准
- •Unable to take oral medication,
- •Immunocompromised
- •Known comorbid condition like hypertension, cardiovascular disease, diabetes mellites, asthma, COPD, cerebrovascular disorder, malignancy of any type, pregnancy,
- •BMI less than 18
- •Smoking history (more than one pack per day)
结局指标
主要结局
Effect on biochemistry parameters as per CTCAE v4.0
时间窗: 15 Days
Routine clinical laboratory blood biochemistry parameters at pre- and post-treatment periods by automated biochemistry analyzer
Effect on CBC as per CTCAE v4.0
时间窗: 15 Days
Routine laboratory complete blood cell count at pre- and post-treatment periods by automated CBC counter Routine laboratory complete blood count Routine clinical laboratory CBC parameters at pre- and post-treatment periods
次要结局
- Lack of adverse events as per CTCAE v4.0(15 days)