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OpenTrials
Completed

NCT Number: NCT04710381

IMUNOR® Preparation in the Prevention of COVID-19

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMUNOR

Drug

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

Primary outcomes

  1. Prevention of COVID-19 disease

    Time frame: 6 or 12 weeks

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

  2. Prevention of hospitalisations due to COVID-19

    Time frame: 6 or 12 weeks

    The number of study subjects requiring hospitalisation due to COVID-19 will be observed

Secondary outcomes

  1. Incidence of sick-leave episodes

    Time frame: 6 or 12 weeks

    The number of study subjects requiring a sick-leave due to COVID-19 will be observed

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2021
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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