Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
COVID-19
Type
Interventional
Phase
Phase 4
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The study treatment (IMUNOR) will be administered to one group of study subjects only.Masking: None (Open Label)Masking Description: No masking will be used in the studyPrimary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT04710381
Collaborators
Not Provided
Investigators
Principal Investigator: Jaromír Bystro?, Ass.Prof.,MD,CSc. University Hospital Ostrava