IMUNOR® preparation in the prevention of COVID-19

Pilot, monocentre, phase-IV clnical trial assessing the clinical effect of per oral immunomodulation treatment using the IMUNOR® preparation in the prevention of COVID-19 disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005524-11-CZ

Enrollment

100

Registered

2020-12-01

Start date

2020-12-21

Completion date

Unknown

Last updated

2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 prevention

Interventions

Trade Name: IMUNOR Product Name: IMUNOR Pharmaceutical Form: Oral lyophilisate INN or Proposed INN: TRANSFER FACTOR, PORCINE Other descriptive name: TRANSFER FACTOR, PORCINE Concentration unit: IU/mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - male/female/all sexes - 18-65 years of age - ability to sign the Informed Consent Form - negative pregnancy test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - use of another immunomodulation treatment in the course of one month prior to enrolment into the study - patients with current, insufficiently controlled cardiac, metabolic, endocrinology, hepatal, renal, neurological or psychiatric disease - known hypersensitivity to the medicinal substance - pregnancy and breasfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the preventive effect of the IMUNOR preparation in healthy subjects against the COVID-19 disease.;Secondary Objective: To evaluate the efficacy of preventive administration of the IMUNOR preparation in healthy subjects against the COVID-19 disease.;Primary end point(s): Evaluation of the number of patients with clinical manifestations corresponding with the SARS-Cov-2 infection;Timepoint(s) of evaluation of this end point: The study subjects will be followed for the period of four weeks.	—

Measure

Time frame

Main Objective: To investigate the preventive effect of the IMUNOR preparation in healthy subjects against the COVID-19 disease.;Secondary Objective: To evaluate the efficacy of preventive administration of the IMUNOR preparation in healthy subjects against the COVID-19 disease.;Primary end point(s): Evaluation of the number of patients with clinical manifestations corresponding with the SARS-Cov-2 infection;Timepoint(s) of evaluation of this end point: The study subjects will be followed for the period of four weeks.

—

Secondary

Measure	Time frame
Secondary end point(s): Semiquantitative evaluation of individual clinical parameters using the monitoring of daily symptom score in subjects with preventive administration of IMUNOR;Timepoint(s) of evaluation of this end point: The study subjects will be followed for the period of four weeks.	—

Countries

Czech Republic

Contacts

Public ContactCentre for Clinical Trials

Fakultní nemocnice Ostrava

jiri.hyncica@fno.cz00420597372587

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026