Pilot, Monocentric, Phase-IV Clinical Trial Assessing the Clinical Effect of Peroral Immunomodulation Treatment Using the IMUNOR® Preparation in the Prevention of COVID-19 Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Prevention of COVID-19 disease
研究概览
简要总结
The aim of the study is to achieve prevention of COVID-19 disease in healthcare professionals with the administration of the IMUNOR® preparation, and decreasing the symptoms should the disease appear.
详细描述
This prospective study is designed to collect data for evaluation of the preventive and therapeutic effect of the IMUNOR® preparation, which is commonly used to treat patients with laboratory or clinical manifestations of immunity disorders. Administration of immunomodulation treatment will be based upon a willing informed consent with the administration of the drug and based upon random selection. The study subjects will receive IMUNOR® preventively; the anticipated preventive effect when using one packing (4 vials) is 6 weeks, and 12 weeks when using two packings. Should any signs of acute illness appear (increased body temperature, cough, loss of smell and taste, etc.), a treatment dose of IMUNOR®, i.e. 1 vial/day (total of 4 vials) will be administered immediately. Monitoring of individual patients will take 6 weeks (1 packing) or 12 weeks (2 packings) from the beginning of IMUNOR® administration. The clinical condition of study subjects will be monitored on a daily basis. At the same time, the possible onset of symptoms will be recorded.
The obtained data will be compared with a control group consisting of patients followed by the Department of Preventive Medicine, University Hospital Ostrava.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
No masking will be used in the study
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study subjects 18-60 years old
- •Ability to cooperate upon the study and to give informed consent
排除标准
- •Use of any other immunomodulation treatment one month prior to enrolment and in the course of the study
- •Acute disease of the cardiovascular, urogenital, respiratory or nervous system
研究组 & 干预措施
IMUNOR
Study subjects in this arm will receive IMUNOR preparation as prevention against COVID-19 disease.
干预措施: IMUNOR (Drug)
结局指标
主要结局
Prevention of COVID-19 disease
时间窗: 6 or 12 weeks
The incidence of COVID-19 disease among the studied population will be assessed.
Prevention of hospitalisations due to COVID-19
时间窗: 6 or 12 weeks
The number of study subjects requiring hospitalisation due to COVID-19 will be observed
次要结局
- Incidence of sick-leave episodes(6 or 12 weeks)
