E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
COVID-19 pneumonia |
COVID-19 pneumonia |
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E.1.1.1 | Medical condition in easily understood language |
COVID-19 pneumonia |
COVID-19 pneumonia |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061229 |
E.1.2 | Term | Lung 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 |
To describe: o Whether IL-6 and CRP levels (at baseline and during treatment) are predictive of treatment efficacy o Trend of the PaO2 / FiO2 ratio o Trend of lymphocyte count o Change of the “Sequential Organ Failure Assessment” (SOFA) o Remission of respiratory symptoms in terms of : time to invasive mechanical ventilation (if not previously initiated) time to definitive extubation (if previously intubated) time to independence from non-invasive mechanical ventilation time to independence from oxygen therapy o Duration of hospitalization o Radiological response To describe the toxicity of tocilizumab
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E.2.2 | Secondary objectives of the trial |
� To compare the compliance of sodium picosulphate and magnesium citrate versus polyethylene glicole as evacuating treatment prior to colonoscopy. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Any gender 2. No age limit 3. Informed consent for participation in the study (consent can be oral if a written consent cannot be expressed. If the subject is incapable of giving an informed consent and an authorized representative is not available without a delay that would, in the opinion of the Investigator, compromise the potential life-saving effect of the treatment this can be administered without consent. Consent to remain in the research should be sought as soon the conditions of the patient will allow it) 4. Virological diagnosis of SARS-CoV-2 infection (real-time PCR) 5. Hospitalized due to clinical/instrumental diagnosis of pneumonia 6. Oxygen saturation at rest in ambient air ≤93% (valid for not intubated patients and for both phase 2 and observational cohort) 7. Intubated less than 24 hours before registration (eligible for phase 2 only – criterium #6 does not apply in this case) 8. Intubated more than 24 hours before registration (eligible for observational cohort only – criterium #6 does not apply in this case) 9. Patients already treated with tocilizumab before registration are eligible for observational cohort only if one criterium among #6, #7, #8 is valid
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E.4 | Principal exclusion criteria |
1. Known hypersensitivity to tocilizumab or its excipients 2. Patient being treated with immunomodulators or anti-rejection drugs 3. Known active infections or other clinical condition that controindicate tocilizumab and cannot be treated or solved according to the judgement of the clinician 4. ALT / AST> 5 times the upper limit of the normality 5. Neutrophils <500 / mmc 6. Platelets <50.000 / mmc 7. Bowel diverticulitis or perforation |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mortality rate one month after registration |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
one month after registration |
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E.5.2 | Secondary end point(s) |
• IL-6 levels • CRP levels • PaO2 / FiO2 ratio • Lymphocyte count • SOFA score • date of intubation (if not previously intubated) • date of definitive extubation (if previously intubated) • date of independence from non-invasive mechanical ventilation • date of independence from oxygen therapy • Days of hospitalization • Radiological response • Rate of adverse events codified by Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
daily up to one mounth after registration |
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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 | 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.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.5 | 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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |