Multicenter Study on the Efficacy and Tolerability of Tocilizumab in the Treatment of Patients With COVID-19 Pneumonia

TOCIVID-19

This study project includes a single-arm phase 2 study and a parallel cohort study, enrolling patients with COVID-19 pneumonia.

2020-03-19

2023-12-19

2023-12-19

Active (not recruiting)

Early phase I

402

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% or requiring oxygen therapy or mechanical ventilation either non invasive or invasive (intubated) 7. Patients with criteria #4 and #5 who have been already treated with tocilizumab before registration are eligible for the observational retrospective cohort Exclusion Criteria: 1. Known hypersensitivity to tocilizumab or its excipients 2. Known active infections or other clinical condition that contraindicate tocilizumab and cannot be treated or solved according to the judgement of the clinician 3. ALT / AST\> 5 times the upper limit of the normality 4. Neutrophils \<500 / mmc 5. Platelets \<50.000 / mmc 6. Bowel diverticulitis or perforation

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a multicenter, single-arm, open-label, phase 2 study. All the patients enrolled are treated with tocilizumab', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 402, 'type': 'ACTUAL'}}

2023-03-24