IMUNOR® Preparation in the Prevention of COVID-19

University Hospital Ostrava

Status and phase: Completed; Phase 4

Conditions: Covid19

Treatments: Drug: IMUNOR

Study type: Interventional

Funder types: Other

Identifiers

NCT04710381

FNO-IMUNOR-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

IMUNOR

Experimental group

Description:

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

Treatment:

Drug: IMUNOR