IMUNOR® Preparation in the Prevention of COVID-19

Phase 4

Completed

• Conditions: Covid19
• Interventions: Drug: IMUNOR

• Registration Number: NCT04710381
• Lead Sponsor: University Hospital Ostrava

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.

Study Timeline

• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-14
• Study Start: 2021-02-01
• Primary Completion: 2021-06-02
• Study Completion: 2021-06-02
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMUNOR	IMUNOR	Study subjects in this arm will receive IMUNOR preparation as prevention against COVID-19 disease.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia