IMUNOR® Preparation in the Prevention of COVID-19
Primary Purpose
Covid19
Status
Completed
Phase
Phase 4
Locations
Czechia
Study Type
Interventional
Intervention
IMUNOR
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring Covid19, prevention, pork dialyzed leukocyte extract, immunomodulation
Eligibility Criteria
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
Sites / Locations
- University Hospital Ostrava
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMUNOR
Arm Description
Study subjects in this arm will receive IMUNOR preparation as prevention against COVID-19 disease.
Outcomes
Primary Outcome Measures
Prevention of COVID-19 disease
The incidence of COVID-19 disease among the studied population will be assessed.
Prevention of hospitalisations due to COVID-19
The number of study subjects requiring hospitalisation due to COVID-19 will be observed
Secondary Outcome Measures
Incidence of sick-leave episodes
The number of study subjects requiring a sick-leave due to COVID-19 will be observed
Full Information
NCT ID
NCT04710381
First Posted
January 13, 2021
Last Updated
July 20, 2021
Sponsor
University Hospital Ostrava
1. Study Identification
Unique Protocol Identification Number
NCT04710381
Brief Title
IMUNOR® Preparation in the Prevention of COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
June 2, 2021 (Actual)
Study Completion Date
June 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Covid19, prevention, pork dialyzed leukocyte extract, immunomodulation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
The study treatment (IMUNOR) will be administered to one group of study subjects only.
Masking
None (Open Label)
Masking Description
No masking will be used in the study
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMUNOR
Arm Type
Experimental
Arm Description
Study subjects in this arm will receive IMUNOR preparation as prevention against COVID-19 disease.
Intervention Type
Drug
Intervention Name(s)
IMUNOR
Intervention Description
The intervention consists of the administration of IMUNOR as prevention against COVID-19 disease
Primary Outcome Measure Information:
Title
Prevention of COVID-19 disease
Description
The incidence of COVID-19 disease among the studied population will be assessed.
Time Frame
6 or 12 weeks
Title
Prevention of hospitalisations due to COVID-19
Description
The number of study subjects requiring hospitalisation due to COVID-19 will be observed
Time Frame
6 or 12 weeks
Secondary Outcome Measure Information:
Title
Incidence of sick-leave episodes
Description
The number of study subjects requiring a sick-leave due to COVID-19 will be observed
Time Frame
6 or 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaromír Bystroň, Ass.Prof.,MD,CSc.
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers.
Learn more about this trial
IMUNOR® Preparation in the Prevention of COVID-19
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