Official Title
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
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.

Completed
COVID19

Drug: IMUNOR

The intervention consists of the administration of IMUNOR as prevention against COVID-19 disease

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 60 Years
Countries
Czechia
Locations

University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia

Jaromír Bystroň, Ass.Prof.,MD,CSc., Principal Investigator
University Hospital Ostrava

University Hospital Ostrava
NCT Number
Keywords
COVID19
prevention
pork dialyzed leukocyte extract
Immunomodulation
MeSH Terms
COVID-19