Official Title
An Open-label Randomized Multicenter Study to Evaluate the Efficacy of Early Administration of Tocilizumab (TCZ) in Patients With COVID-19 Pneumonia
Brief Summary

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.

Terminated
COVID-19 Pneumonia

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Italy
Locations

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

Azienda Unità Sanitaria Locale Reggio Emilia
NCT Number
MeSH Terms
COVID-19
Pneumonia