E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate COVID-19-related pneumonia |
Polmonite COVID-19-correlata di grado moderato |
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E.1.1.1 | Medical condition in easily understood language |
Moderate COVID-19-related pneumonia |
Polmonite COVID-19-correlata di grado moderato |
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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 | 10051905 |
E.1.2 | Term | Coronavirus infection |
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 |
The safety and a proof of concept of efficacy of the treatment |
Sicurezza ed efficacia di risposta al trattamento |
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E.2.2 | Secondary objectives of the trial |
• Survival rate within 8 and 28 days • > than 40% decrease in PaO2/FiO2 ratio • Peripheral capillary oxygen saturation (SpO2) at day 1,2,3,4,5,6,7,14 and 28 • PaO2 at day 1,2,4,6,7 and 10 • Admission to the ICU • Length of hospital stay • Re-admission within 28 days • The cumulative incidence and severity of adverse events |
1. sopravvivenza a 8 e 28 giorni; 2. % di pazienti con riduzione > 40% di PaO2/FiO2 3. Saturazione periferica di Ossigeno (SpO2) ai giorni 1,2,3,4,5,6,7,14 and 28 4. PaO2 ai giorni 1,2,4,6,7 e 10. 5. % Ricoveri in terapia intensiva; 6. durata del ricovero; 7. re-ospedalizzazione a 28 giorni; 8. incidenza cumulativa e severità di eventi avversi |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Ability to obtain informed patient consent noting the limitations of existing knowledge regarding Inhaled Liposomal CSA efficacy and the labeled warning and precautions as the proposed use is outside the approved indication. • Informed Consent as documented by signature • Adult patients aged 18-74 years-old • Bilateral infiltrates at chest radiography • =48 hours from admission • Positive Nasal Swab at PCR assay specific for SARS-CoV-2 • Moderate acute respiratory syndrome (SARS)-CoV-2 pneumonia PaO2/FiO2 between 300-200 in FiO2 </=60%) • Ability to perform 8-13 min aerosolization • Evidence of clear hyperinflammatory state (CRP >5mg/dl, IL6 levels >40 pg/ml) • Exclusion of coinfection by PTCI < than 0.5 ng/ml |
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E.4 | Principal exclusion criteria |
• Patients aged < 18 years old and = 75 years old • Concomitant and documented bacterial infection or PCTI > 0.5 ng/ml • Lymphopenia less than 200/mmc • Hemoglobin < 8 g/dl • Absolute neutrophil count < 1 x 109 cells/L • PaO2/FiO2 not included in the following interval 300-200 need of a FiO2 support > than 60% • Treatment with CPAP and /or inability to perform a 10 min aerosolization course • Sudden clinical deterioration requiring ICU access or palliative care • Known hypersensitivity or allergy to CSA • Creatinine clearance < 30 mL/min; • Severe hepatic impairment • Pregnant or breast-feeding • Active tuberculosis • Evidence of active HBV (HbsAg positive) or with detectable HCV-RNA, HIV |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome will be safety and response to treatment. A patient is considered responder in the absence of oxygenation impairment (>than 40% decrease in PaO2/FiO2 ratio) within 7 days from enrolment. |
Numero di pazienti che tollerano la somministrazione per inalazione senza eventi avversi maggiori (almeno 80% per passare da fase IIa (di safety) a Fase IIb (di efficacia) il cui obiettivo è oltre alla sicurezza la valutazione di risposta al trattamento definita come miglioramento dell’ossigenazione ovvero assenza di peggioramento > 40% del ratio di PaO2/FiO2 entro 7 giorni dall’arruolamento |
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E.5.1.1 | 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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
terapia antivirale e di supporto |
antiviral and supportive therapy |
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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
| 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 | 2 |
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 | Information not present in EudraCT |
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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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |