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 |
COVID-19 pneumonia |
polmonite COVID-19 |
|
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 | LLT |
E.1.2 | Classification code | 10053983 |
E.1.2 | Term | Corona virus infection |
E.1.2 | System Organ Class | 100000004862 |
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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 |
Evualuate the efficacy of the injection of three boluses of Methylprednisolone (1 gr/die for three days), in addition to standard therapy in patients with COVID-19 pneumonia in terms of time to discharge from the hospital |
Valutazione dell’efficacia di tre boli di Metilprednisolone (1 gr/die per tre giorni), in aggiunta alla terapia standard in pazienti affetti da polmonite COVID-19 in termini di tempo alla dimissione dall’ospedale |
|
E.2.2 | Secondary objectives of the trial |
Evaluation of the effectiveness of three boluses of methylprednisolone (1 g / day for three days), in addition to standard therapy in patients with COVID-19 pneumonia in terms of: a. prevention of invasive ventilation with oro-tracheal intubation b. survival for all causes Safety assessment throughout the study period |
Valutazione dell’efficacia di tre boli di Metilprednisolone (1 gr/die per tre giorni), in aggiunta alla terapia standard in pazienti affetti da polmonite COVID-19 in termini di: a. prevenzione della ventilazione invasiva con intubazione oro-tracheale b. sopravvivenza per tutte le cause Valutazione della safety nell’intero periodo dello studio |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. age = 18 years; 2. Informed consent for participation in the study and for data processing; 3. Molecular diagnosis with Polymerase Chain Reaction (PCR) test of Sars-CoV2 infection; 4. Hospitalization in a specialist ward for Covid-19 patient care (eg., Infectious Diseases, Pulmonology or Internal Medicine); 5. Need for supplemental oxygen in any delivery mode with the exception of invasive mechanical ventilation; 6. PaO2 / FiO2 between 100 and 300 mmHg. 7. Clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray or lung ultrasound) of interstitial pneumonia for no more than three days; 8. Serum CRP greater than 5 mg / dL; 9. Interval from onset of SARS-CoV2 infection symptoms to randomization> 5 days |
1. età = 18 anni; 2. Consenso informato per la partecipazione allo studio e per il trattamento dei dati; 3. Diagnosi molecolare con test Polymerase Chain Reaction (PCR) dell'infezione da Sars-CoV2; 4. Ricovero in ospedale in un reparto specialistico per la cura dei pazienti Covid-19 (ad es. Malattie infettive, Pneumologia o Medicina Interna); 5. Necessità di ossigeno supplementare in qualsiasi modalità di erogazione con esclusione della ventilazione meccanica invasiva. 6. PaO2/FiO2 compresa fra 100 e 300 mmHg. 7. Diagnosi clinica/strumentale (TAC torace ad alta risoluzione oppure Rx torace oppure ecografia polmonare) di polmonite interstiziale da non più di tre giorni; 8. PCR sierica maggiore di 5 mg/dl 9. Intervallo fra comparsa dei sintomi di infezione da SARS-CoV2 e randomizzazione > 5 giorni |
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E.4 | Principal exclusion criteria |
1. Invasive mechanical ventilation; 2. Presence of shock or concomitant organ failure that requires admission to the Intensive Care Unit; 3. Pregnancy or breastfeeding; 4. Severe heart or kidney failure; 5. Known hypersensitivity to methylprednisolone, to dexamethasone or to an exception; 6. Diabetes not compensated according to the doctor's judgment; 7. Other clinical conditions that contraindicate Methylprednisolone and cannot be treated or resolved according to the doctor's judgment; 8. Steroid bolus therapy in the week prior to enrollment for the study; 9. Enrollment in another clinical trial; 10. Patient already randomized in this study |
1. Ventilazione meccanica invasiva 2. Presenza di shock o di concomitante insufficienza d’organo che richiede ammissione all’Unità di Cura Intensiva; 3. Gravidanza o allattamento; 4. Insufficienza cardiaca o renale grave; 5. Ipersensibilità nota al metilprednisolone, al desametasone o ad un eccepiente; 6. Diabete non compensato secondo il giudizio del medico 7. Altre condizioni cliniche che controindicano il Metilprednisolone e non possono essere trattate o risolte secondo il giudizio del medico; 8. Terapia con boli steroidei nella settimana precedente l’arruolamento per lo studio 9. Arruolamento in altra sperimentazione clinica 10. Paziente già randomizzato in questo studio |
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E.5 End points |
E.5.1 | Primary end point(s) |
Lenght of hospitalization, calculated as the interval between randomization and discharge from the hospital without the need for supplemental oxygen |
Durata del ricovero in ospedale, calcolata come intervallo tra la randomizzazione e la dimissione dall’ospedale senza necessità di ossigeno supplementare |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 days since randomisation |
30 giorni dalla randomizzazione |
|
E.5.2 | Secondary end point(s) |
Invasive ventilation-free survival with orotracheal intubation; Overall survival, defined as the time between randomisation and death for any cause |
Sopravvivenza libera da ventilazione invasiva con intubazione orotracheale; Sopravvivenza complessiva, definita come intervallo tra la randomizzazione e l’eventuale decesso per qualsiasi causa |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
30 days since randomisation; 30 days since randomisation |
30 giorni dalla randomizzazione; 30 giorni dalla randomizzazione |
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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 | No |
E.6.5 | Efficacy | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
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
| 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 | 5 |
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 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |