A randomized, open-label, phase IV monocentric study evaluating the clinical effect of oral immunomodulatory therapy with IMUNOR® in patients with moderate COVID-19 disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002497-27-CZ

Enrollment

Registered

2020-10-22

Start date

2020-10-27

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Patients with COVID -19 disease

Interventions

Trade Name: IMUNOR Product Name: Imunor Pharmaceutical Form: Oral lyophilisate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Women or men aged 18 and over; • Documented incidence of COVID-19 disease with moderate clinical manifestations requiring hospitalization (as assessed by the attending physician); • The patient's ability to cooperate and sign the informed consent form; 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: • Use of any other immunomodulatory treatment during the last month before entering the study (bacterial lysates, immunoglucans, immunoglobulins, etc.) • Need for pulmonary ventilation at study entry; • Known hypersensitivity to the active substance; • Pregnancy and breast-feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: to verify the potential of a registered drug in the fight against a highly contagious pandemic disease;Secondary Objective: - frequency of worsening of patients into severe disease with the need for supportive lung ventilation; - frequency of exacerbation of patients into severe disease requiring hydroxychloroquine; time to normalization of immunological parameters (especially lymphocyte subpopulations); - time to normalization of body temperature, CRP, leukocyte count; - length of hospital stay; - rate of virus elimination from HCD secretions; - occurrence of adverse events. - Consumption of ATB prescribed for the treatment of respiratory infections;Primary end point(s): evaluation of the change in symptom score within 2 weeks of starting IMUNOR administration;Timepoint(s) of evaluation of this end point: 2 weeks of starting IMUNOR administration	—

Measure

Time frame

Main Objective: to verify the potential of a registered drug in the fight against a highly contagious pandemic disease;Secondary Objective: - frequency of worsening of patients into severe disease with the need for supportive lung ventilation; - frequency of exacerbation of patients into severe disease requiring hydroxychloroquine; time to normalization of immunological parameters (especially lymphocyte subpopulations); - time to normalization of body temperature, CRP, leukocyte count; - length of hospital stay; - rate of virus elimination from HCD secretions; - occurrence of adverse events. - Consumption of ATB prescribed for the treatment of respiratory infections;Primary end point(s): evaluation of the change in symptom score within 2 weeks of starting IMUNOR administration;Timepoint(s) of evaluation of this end point: 2 weeks of starting IMUNOR administration

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Secondary

Measure	Time frame
Secondary end point(s): - frequency of worsening of patients into severe disease with the need for supportive lung ventilation; - frequency of exacerbation of patients into severe disease requiring hydroxychloroquine; time to normalization of immunological parameters (especially lymphocyte subpopulations); - time to normalization of body temperature, CRP, leukocyte count; - length of hospital stay; - rate of virus elimination from HCD secretions; - occurrence of adverse events. - Consumption of ATB prescribed for the treatment of respiratory infections;Timepoint(s) of evaluation of this end point: weekly, till Day 28	—

Measure

Time frame

Secondary end point(s): - frequency of worsening of patients into severe disease with the need for supportive lung ventilation; - frequency of exacerbation of patients into severe disease requiring hydroxychloroquine; time to normalization of immunological parameters (especially lymphocyte subpopulations); - time to normalization of body temperature, CRP, leukocyte count; - length of hospital stay; - rate of virus elimination from HCD secretions; - occurrence of adverse events. - Consumption of ATB prescribed for the treatment of respiratory infections;Timepoint(s) of evaluation of this end point: weekly, till Day 28

—

Countries

Czech Republic

Contacts

Public ContactSkopek -trial coordinator

Thomayerova nemocnice

jiri.skopek1@ftn.cz420261082567

Outcome results

None listed

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