E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Patients with new type of coronavirus (COVID-19) infection |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10084268 |
E.1.2 | Term | COVID-19 |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 assess the safety and tolerability of REM use in Hungary in the conditionally approved indication (EMA). |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of REM in COVID-19 patients Hungary |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
o Males or females aged 12yrs and older with body weight at least 40kg o Hospitalized with COVID-19 confirmed by PCR and/or COVID-19 typical symptoms with pneumonia: In case of no confirmed PCR test result available at screening, typical symptoms can also apply o requiring supplemental oxygen at screening at the discretion of the investigator, any form of O2 support can apply o Do not have access to Veklury treatment Patient may be under other treatment against COVID-19 (except for chloroquine/hydroxychloroquine) o Willing and able to provide valid written informed consent prior to performing study procedures (for those <18yrs of age, parental consent and patient assent is required)
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E.4 | Principal exclusion criteria |
Patients meeting any of the below criteria are not eligible o Known liver disease, hepatic impairment and/or Alanine Transaminase (ALT) or Aspartate Transaminase (AST) ≥ 5 times the upper limit of normal o Known severe renal disease (including patients receiving hemodialysis or hemofiltration) and/or estimated glomerular filtration rate (eGFR) < 30 ml/min. o Pregnancy or breast feeding at the discretion of the investigator o Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 120 hours o Other investigationsl treatment up to 2x the “emptying” time of treatment, or if this is not known for 60 days, except in the case of a favipiravir study. In case of the clinical trial of favipiravir the petinents can be enrolled in the study if afterthe end of study / early termination visit. o Know allergy to any anti-viral medication Hypersensitivity to the active substance(s) or to any of the excipients o Current (or 48 hours prior) treatment with chloroquine/hydroxychloroquine o Any medical condition that the examining physician deems unsuitable for the patient to participate in the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
<PRIM> The primary endpoint of the study is the proportion of patients with at least 1treatment-emergent AESI (death, hypersensitivity including infusion-related reaction, anaphylactic reaction, acute respiratory failure, hypotension, hepatic toxicity and nephrotoxicity). Secondary endpoints: The secondary safety endpoints of the study are: <SEC1> the proportion of patients with at least 1 treatment-emergent adverse event <SEC2> proportion of patients with treatment-emergent clinical laboratory abnormalities (separately for the following parameters: ALT, AST, INR, HGB, Bilirubin, ALP, Creatinine, eGFR)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
<SEC3> time to recovery (days) <SEC4> time to discharge from hospital (days) <SEC5> number and proportion of patients at prespecified timepoints in each category of the WHO Ordinal Scale for Clinical Improvement <SEC5> number and proportion of patients at prespecified timepoints in each category (Ambient air, Low flow, Medium Flow, High Flow, Non invasive ventilation, Invasive ventilation, ECMO) <SEC6> proportion of participants with normalization of fever (<37°C) through Day 10 with 14 days follow-up after the last dose <SEC7> proportion of participants with normalization of oxygen saturation (>=95%) through Day 10 with 14 days follow-up after the last dose
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.3 | Therapy | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
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 | Yes |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |