The clinical study aims at assessing whether early administration of Tocilizumab compared to late administration of Tocilizumab can reduce the number of patients with COVID-19 pneumonia who require mechanical ventilation. The clinical study includes patients with recent-onset COVID-19 pneumonia who require hospital care, but not invasive or semi-invasive mechanical ventilation procedures.
Drug: Tocilizumab
In case of aggravation of COVID-19 pneumonia, according to protocol criteria, participants will receive 8 mg/kg IV up to a maximum of 800 mg with repetition of the same dosage after 12 hours
Other Name: Standard of care
Inclusion Criteria:
- age > 18 years
- Informed consent for participation in the study
- Real time polymerase chain reaction (PCR) diagnosis of Sars-CoV2 infection
- Hospitalization due to clinical / instrumental diagnosis (high resolution chest CT
scan or chest x-ray or pulmonary ultrasound)
- Presence of acute respiratory distress syndrome with arterial partial pressure of
oxygen / fraction of inspired oxygen (PaO2 / FiO2) between 200 and 300 mm/Hg
- Presence of exaggerated inflammatory response defined by the presence of at least 1 of
the following criteria:
- At least one body temperature measurement >38° C in the past two days;
- Serum CRP greater than or equal to 10 mg/dl;
- CRP increase of at least twice the basal value
Exclusion Criteria:
- Patients with respiratory distress syndrome with arterial partial pressure of oxygen /
fraction of inspired oxygen (PaO2 / FiO2) <200 mm/Hg or
- Patients in non-invasive ventilation or
- Patients in invasive ventilation or presence of shock or presence of concomitant organ
failure that requires admission to the Intensive Care Unit
- Severe heart and kidney failure
- Pregnant or breastfeeding patient
- Patient who, in the opinion of the clinician or by the patient's express will, will
not go to intensive care regardless of the evolution of the lung picture.
- Known hypersensitivity to TCZ or its excipients
- Patient being treated with immuno-depressors or anti-rejection drugs
- Known active infections or other clinical conditions that contraindicate TCZ and
cannot be treated or resolved according to the physician's judgment
- 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
Ospedale di Guastalla
Guastalla, RE, Italy
Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia
Reggio Emilia, RE, Italy
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Policlinico Sant'Orsola Malpighi
Bologna, Italy
ASST Cremona
Cremona, Italy
Azienda Ospedaliera S. Croce e Carle
Cuneo, Italy
Azienda Ospedaliero Universitaria Ferrara
Ferrara, Italy
Azienda Ospedaliero Universitaria Careggi
Firenze, Italy
Ospedale Evangelico Internazionale di Genova
Genova, Italy
Azienda Sociosanitaria ASL 1 ,Imperia
Imperia, Italy
Azienda Sociosanitaria ASL 5 La Spezia
La Spezia, Italy
ASST Mantova - Ospedale Carlo Poma
Mantova, Italy
IRCCS Istituto Auxologico Italiano Milano
Milano, Italy
Azienda Ospedaliero-Universitaria "Maggiore della Carità" di Novara
Novara, Italy
Ospedali Riuniti Padova Sud - ULSS 6 Euganea
Padova, Italy
Azienda Ospedaliero-Universitaria Parma
Parma, Italy
Azienda Unità Sanitaria Locale di Piacenza
Piacenza, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy
AO Ordine Mauriziano di Torino
Torino, Italy
ASST Bergamo Ovest -Treviglio
Treviglio, Italy
AULSS 2 Marca Trevigiana
Treviso, Italy
AULSS2 Marca Trevigiana - Ospedale Vittorio Veneto
Treviso, Italy
AULSS 3 Serenissima Ospedale "Dell'Angelo"
Venezia, Italy
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Italy
IRCCS Sacro Cuore Don Calabria
Verona, Italy