IMUNOR® Preparation in the Prevention of COVID-19

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04710381

Enrollment

Registered

2021-01-14

Start date

2021-02-01

Completion date

2021-06-02

Last updated

2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

Covid19, prevention, pork dialyzed leukocyte extract, immunomodulation

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.

Interventions

DRUGIMUNOR

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Masking description

No masking will be used in the study

Intervention model description

The study treatment (IMUNOR) will be administered to one group of study subjects only.

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026