IMUNOR® Preparation in the Prevention of COVID-19

NCT04710381 | Completed Phase 4

• 1 other identifier: FNO-IMUNOR-2020
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Covid19; prevention; pork dialyzed leukocyte extract; immunomodulation

Outcome Measures

Primary Outcomes (2)

• Prevention of COVID-19 disease

  The incidence of COVID-19 disease among the studied population will be assessed.

  6 or 12 weeks

• 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 Outcomes (1)

• Incidence of sick-leave episodes

  6 or 12 weeks

Study Arms (1)

IMUNOR

EXPERIMENTAL

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

Drug: IMUNOR

Interventions

IMUNOR DRUG

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

IMUNOR

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Study subjects 18-60 years old
• Ability to cooperate upon the study and to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

MeSH Terms

Conditions

COVID-19

Interventions

IMUNOR

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jaromír Bystroň, Ass.Prof.,MD,CSc.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: No masking will be used in the study
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 14, 2021
• Study Start: February 1, 2021
• Primary Completion: June 2, 2021
• Study Completion: June 2, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)