IMUNOR® Preparation in the Prevention of COVID-19
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IMUNOR Study subjects in this arm will receive IMUNOR preparation as prevention against COVID-19 disease. |
Drug: IMUNOR
The intervention consists of the administration of IMUNOR as prevention against COVID-19 disease
|
Outcome Measures
Primary Outcome Measures
- Prevention of COVID-19 disease [6 or 12 weeks]
The incidence of COVID-19 disease among the studied population will be assessed.
- Prevention of hospitalisations due to COVID-19 [6 or 12 weeks]
The number of study subjects requiring hospitalisation due to COVID-19 will be observed
Secondary Outcome Measures
- Incidence of sick-leave episodes [6 or 12 weeks]
The number of study subjects requiring a sick-leave due to COVID-19 will be observed
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Ostrava | Ostrava | Moravian-Silesian Region | Czechia | 70852 |
Sponsors and Collaborators
- University Hospital Ostrava
Investigators
- Principal Investigator: Jaromír Bystroň, Ass.Prof.,MD,CSc., University Hospital Ostrava
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FNO-IMUNOR-2020