E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
COVID-19 prevention |
prevence onemocnění COVID-19 |
|
E.1.1.1 | Medical condition in easily understood language |
COVID-19 prevention |
prevence onemocnění COVID-19 |
|
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 investigate the preventive effect of the IMUNOR preparation in healthy subjects against the COVID-19 disease. |
Zkoumat preventivní efekt léku IMUNOR u zdravých subjektů hodnocení proti onemocnění COVID-19. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of preventive administration of the IMUNOR preparation in healthy subjects against the COVID-19 disease. |
Vyhodnocení účinnosti preventivního podání léku IMUNOR u zdravých subjektů proti onemocnění COVID-19. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- male/female/all sexes - 18-65 years of age - ability to sign the Informed Consent Form - negative pregnancy test |
- muž/žena - věk 18-65 let - schopnost podepsat Informovaný souhlas - negativní těhotenský test |
|
E.4 | Principal 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 |
- použití jiné imunomodulační léčby v průběhu posledního měsíce před vstupem do studie - pacienti s probíhajícím nedostatečně kontrolovaným kardiálním, metabolickým endokrinologickým, hepatálním, renálním, neurologickým či psychiatrickým onemocněním - známá hypersensitivita na léčivou látku - těhotenství a kojení |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of the number of patients with clinical manifestations corresponding with the SARS-Cov-2 infection |
Vyhodnocení počtu pacientů, u kterých se objeví klinické potíže odpovídající infekci SARS-Cov-2 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The study subjects will be followed for the period of four weeks. |
Subjekty hodnocení budou sledovány po dobu čtyř týdnů. |
|
E.5.2 | Secondary end point(s) |
Semiquantitative evaluation of individual clinical parameters using the monitoring of daily symptom score in subjects with preventive administration of IMUNOR |
Semikvantitativní hodnocení jednotlivých klinických parametrů sledováním denního symptomového skore u subjektů s preventivním podáváním IMUNORU |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
The study subjects will be followed for the period of four weeks. |
Subjekty hodnocení budou sledovány po dobu čtyř týdnů. |
|
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 | No |
E.6.4 | Safety | No |
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 | No |
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 | 1 |
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
|
LVLS |
poslední návštěva posledního subjektu hodnocení |
|
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 | |
E.8.9.1 | In the Member State concerned days | |