E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with COVID -19 disease |
Pacienti trpící infekcí COVID-19 |
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E.1.1.1 | Medical condition in easily understood language |
Patients with COVID -19 disease |
Pacienti trpící infekcí COVID-19 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to verify the potential of a registered drug in the fight against a highly contagious pandemic disease |
ověřit potenciál registrovaného léčiva v boji proti vysoce nakažlivému pandemicky se šířícímu onemocnění |
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E.2.2 | Secondary objectives of the trial |
- 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 |
-četnost zhoršení pacientů do těžké formy onemocnění s potřebou podpůrné plicní ventilace;
-četnost zhoršení pacientů do těžké formy onemocnění s potřebou podání hydroxychlorochinu; doba do normalizace imunologických parametrů (především subpopulací lymfocytů);
-doba do normalizace tělesné teploty, CRP, počtu leukocytů;
-doba hospitalizace;
-rychlost eliminace viru ze sekretů HCD;
-výskyt nežádoucích příhod.
-Spotřeba ATB předepsaných k léčbě infekcí dýchacích cest
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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; |
•Ženy, nebo muži ve věku 18 a více let;
•Zdokumentovaný výskyt onemocnění COVID-19 s klinickými projevy středního stupně vyžadující hospitalizaci (dle hodnocení ošetřujícího lékaře);
•Schopnost pacienta spolupracovat a podepsat formulář informovaného souhlasu;
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E.4 | Principal 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 |
•Použití jakékoliv jiné imunomodulační léčby v průběhu posledního měsíce před vstupem do studie (bakteriální lyzáty, imunoglukany, imunoglobuliny apod.)
•Potřeba plicní ventilace v čase vstupu do studie;
•Známá hypersenzitivita na léčivou látku;
•Těhotenství a kojení
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E.5 End points |
E.5.1 | Primary end point(s) |
evaluation of the change in symptom score within 2 weeks of starting IMUNOR administration |
vyhodnocení změny symptomového skóre v průběhu 2 týdnů od zahájení podávání IMUNORU |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 weeks of starting IMUNOR administration |
2 týdnů od zahájení podávání IMUNORU |
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E.5.2 | 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 |
-četnost zhoršení pacientů do těžké formy onemocnění s potřebou podpůrné plicní ventilace;
-četnost zhoršení pacientů do těžké formy onemocnění s potřebou podání hydroxychlorochinu; doba do normalizace imunologických parametrů (především subpopulací lymfocytů);
-doba do normalizace tělesné teploty, CRP, počtu leukocytů;
-doba hospitalizace;
-rychlost eliminace viru ze sekretů HCD;
-výskyt nežádoucích příhod.
-Spotřeba ATB předepsaných k léčbě infekcí dýchacích cest
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
weekly, till Day 28 |
týdně, do dne 28 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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1) last visit of the last subject undergoing the trial
2) premature end of trial due to lack of patients |
1) last visit of the last subject undergoing the trial
2) premature end of trial due to lack of patients |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |