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
Overview
- Phase
- Phase 4
- Intervention
- IMUNOR
- Conditions
- Covid19
- Sponsor
- University Hospital Ostrava
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Prevention of COVID-19 disease
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Study subjects 18-60 years old
- •Ability to cooperate upon the study and to give informed consent
Exclusion Criteria
- •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
Arms & Interventions
IMUNOR
Study subjects in this arm will receive IMUNOR preparation as prevention against COVID-19 disease.
Intervention: IMUNOR
Outcomes
Primary Outcomes
Prevention of COVID-19 disease
Time Frame: 6 or 12 weeks
The incidence of COVID-19 disease among the studied population will be assessed.
Prevention of hospitalisations due to COVID-19
Time Frame: 6 or 12 weeks
The number of study subjects requiring hospitalisation due to COVID-19 will be observed
Secondary Outcomes
- Incidence of sick-leave episodes(6 or 12 weeks)