App-based Symptom Tracking After Corona Vaccination (CoCoV)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related side effects
研究概览
简要总结
The study investigates the side effects of different COVID-19 vaccines.
详细描述
In this observational study side effects of COVID-19 vaccines will be documented using an open-source mobile application. Participants are invited to answer a questionnaire on a daily basis. Common and unknown events are queried and collected. The primary result of this study will be a descriptive analysis of the collected data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •received COVID-19 vaccination
- •age ≥ 18 years
- •mobile device (iOS or Android)
排除标准
- •No knowledge of German or English language
- •No written informed consent
结局指标
主要结局
Number of participants with treatment-related side effects
时间窗: 4 weeks
Number of participants with treatment-related side effects as assessed by the toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (status September 2007)
次要结局
- Distribution and deviation of documented side effects(4 weeks)
研究者
Thomas Seufferlein
Professor, Head of Department
University Hospital Ulm