EUCTR2020-005291-35-ITActive, not recruitingPhase 1
A multicenter randomized trial to evaluate the efficacy of tocilizumab in patients with severe Coronavirus Disease 2019 (Covid-19) pneumonia failing glucocorticoids. - ANTICIPANT
AOU POLICLINICO DI MODENA0 sites640 target enrollmentStarted: March 22, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 640
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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