IMUNOR® Preparation in the Prevention of COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Drug: IMUNOR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: The study treatment (IMUNOR) will be administered to one group of study subjects only.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMUNOR<br>Study subjects in this arm will receive IMUNOR preparation as prevention against COVID-19 disease. | Drug: IMUNOR<br>* The intervention consists of the administration of IMUNOR as prevention against COVID-19 disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of COVID-19 disease | The incidence of COVID-19 disease among the studied population will be assessed. | 6 or 12 weeks | 
| Prevention of hospitalisations due to COVID-19 | The number of study subjects requiring hospitalisation due to COVID-19 will be observed | 6 or 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of sick-leave episodes | The number of study subjects requiring a sick-leave due to COVID-19 will be observed | 6 or 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid19, prevention, pork dialyzed leukocyte extract, immunomodulation