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临床试验/NCT04710381
NCT04710381已完成4 期

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

University Hospital Ostrava1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2021年2月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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)

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (1)

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