A multicenter randomized trial to evaluate the efficacy of tocilizumab in patients with severe Coronavirus Disease 2019 (Covid-19) pneumonia failing glucocorticoids.
- Conditions
- polmonite severa da coronavirus 2019MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-005291-35-IT
- Lead Sponsor
- AOU POLICLINICO DI MODENA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 640
• age>= 18 years;
• Informed consent for participation in the study;
• Polymerase Chain Reaction (Real-time PCR) diagnosis of Sars-CoV2 infection;
• Hospitalization;
• Clinical/instrumental diagnosis (high resolution chest computed tomography scan or chest x-ray or pulmonary ultrasound) of COVID-19 pneumonia;
• PaO2/FiO2 ratio in room air <250 mmHg and decreased by more than 20% and/or respiratory distress (RR> 30 bpm and/or use of accessory respiratory muscles) occurs despite treatment at least 36 hours from first dexamethasone dose. The interval has been chosen on the basis of clinical experience with the timing of clinical improvement after starting this treatment.
• An hyperinflammation condition defined by the presence of at least two of the following criteria at any time from admission: a) blood lymphocytes < 1000/mmc; b) ferritin > 500ng/mL; c) LDH > 300 U/L; d) D-dimers > 1000 ng/mL; e) Creactive protein > 3mg/dL
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
• Patient with acute respiratory distress syndrome with PaO2/FiO2 ratio > 250 mmHg;
• Invasive ventilation (oro-tracheal intubation);
• Known hypersensitivity to TCZ or its excipients;
• Clinical conditions that contraindicate TCZ and cannot be treated or resolved according to the physician's judgment: e.g. Glutamate-pyruvate transaminase (GPT) or glutamine oxaloacetic transaminase (GOT) > 5 times the upper limit of the norm, Neutrophils < 500/mmc, Platelets < 50.000/mmc, Diverticulitis or intestinal perforation, suspicion of latent tuberculosis;
• Previous or concomitant use of other immune-modulants for COVID-19: anti-IL-1, JAK-inhibitors, other anti-IL-6
• PCT > 0.5 ng/mL
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method