IMUNOR® Preparation in the Prevention of COVID-19

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04710381
• Other study ID #: FNO-IMUNOR-2020
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2021
• Est. completion date: June 2, 2021

Study information

• Verified date: July 2021
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2, 2021
• Est. primary completion date: June 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

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

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of COVID-19 disease	The incidence of COVID-19 disease among the studied population will be assessed.	6 or 12 weeks
Primary	Prevention of hospitalisations due to COVID-19	The number of study subjects requiring hospitalisation due to COVID-19 will be observed	6 or 12 weeks
Secondary	Incidence of sick-leave episodes	The number of study subjects requiring a sick-leave due to COVID-19 will be observed	6 or 12 weeks