Multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia
- Conditions
- COVID-19 pneumoniaMedDRA version: 20.0Level: PTClassification code 10061229Term: Lung infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-001110-38-IT
- Lead Sponsor
- ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 330
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 230
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To describe:<br>oWhether IL-6 and CRP levels (at baseline and during treatment) are predictive of treatment efficacy<br>oTrend of the PaO2 / FiO2 ratio<br>oTrend of lymphocyte count<br>oChange of the Sequential Organ Failure Assessment” (SOFA) <br>oRemission of respiratory symptoms in terms of :<br>?time to invasive mechanical ventilation (if not previously initiated)<br>?time to definitive extubation (if previously intubated)<br>?time to independence from non-invasive mechanical ventilation<br>?time to independence from oxygen therapy<br>oDuration of hospitalization<br>oRadiological response <br>To describe the toxicity of tocilizumab<br><br>;Secondary Objective: ?To compare the compliance of sodium picosulphate and magnesium citrate versus polyethylene glicole as evacuating treatment prior to colonoscopy.;Primary end point(s): Mortality rate one month after registration;Timepoint(s) of evaluation of this end point: one month after registration
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •IL-6 levels<br>•CRP levels <br>•PaO2 / FiO2 ratio<br>•Lymphocyte count<br>•SOFA score<br>•date of intubation (if not previously intubated)<br>•date of definitive extubation (if previously intubated)<br>•date of independence from non-invasive mechanical ventilation<br>•date of independence from oxygen therapy<br>•Days of hospitalization<br>•Radiological response <br>•Rate of adverse events codified by Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0<br>;Timepoint(s) of evaluation of this end point: daily up to one mounth after registration