Efficacy of Early Administration of Tocilizumab in COVID-19 Patients
- Registration Number
- NCT04346355
- Lead Sponsor
- Azienda Unità Sanitaria Locale Reggio Emilia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 126
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Arm Tocilizumab Tocilizumab within 8 hours from entering the study + standard of care; 8 mg/kg IV up to a maximum of 800 mg with repetition of the same dosage after 12 hours Control Arm Tocilizumab Standard of care; In the event 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
- Primary Outcome Measures
Name Time Method Entry into Intensive Care with invasive mechanical ventilation or death from any cause or clinical aggravation two weeks from participants' allocation to study arm Entry into Intensive Care with invasive mechanical ventilation or death from any cause or clinical aggravation documented by the finding of a PaO2 / FiO2 ratio \<150mm / Hg confirmed by a second arterial blood gas (ABG) measurement within four hours
- Secondary Outcome Measures
Name Time Method Death from any cause Two weeks from participants' allocation to study arm Death
Tocilizumab toxicity Two weeks from participants' allocation to study arm Adverse events (AE) classified according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale
Levels of interleukin-6 and C-reactive protein (CRP) and their correlation with the effectiveness of the treatment Two weeks from participants' allocation to study arm Levels of ferritin, lactate dehydrogenase and D-dimer and their correlation with the effectiveness of the treatment
Evaluate the progress of the PaO2 / FiO2 ratio Two weeks from participants' allocation to study arm Changes from baseline of the PaO2 / FiO2 ratio
Evaluate the trend over time of the lymphocyte count Two weeks from participants' allocation to study arm Changes from baseline of the lymphocyte count
Trial Locations
- Locations (25)
Ospedale di Guastalla
🇮🇹Guastalla, RE, Italy
Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia
🇮🇹Reggio Emilia, RE, Italy
ASST Cremona
🇮🇹Cremona, Italy
Policlinico Sant'Orsola Malpighi
🇮🇹Bologna, Italy
Ospedale Evangelico Internazionale di Genova
🇮🇹Genova, Italy
Azienda Ospedaliero Universitaria Ferrara
🇮🇹Ferrara, Italy
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, Italy
Azienda Ospedaliera S. Croce e Carle
🇮🇹Cuneo, Italy
Azienda Ospedaliero Universitaria Careggi
🇮🇹Firenze, Italy
Azienda Sociosanitaria ASL 5 La Spezia
🇮🇹La Spezia, Italy
ASST Mantova - Ospedale Carlo Poma
🇮🇹Mantova, Italy
Ospedali Riuniti Padova Sud - ULSS 6 Euganea
🇮🇹Padova, Italy
IRCCS Istituto Auxologico Italiano Milano
🇮🇹Milano, Italy
Azienda Ospedaliero-Universitaria Parma
🇮🇹Parma, Italy
Azienda Unità Sanitaria Locale di Piacenza
🇮🇹Piacenza, Italy
AO Ordine Mauriziano di Torino
🇮🇹Torino, Italy
Azienda Ospedaliera Universitaria Pisana
🇮🇹Pisa, Italy
ASST Bergamo Ovest -Treviglio
🇮🇹Treviglio, Italy
AULSS2 Marca Trevigiana - Ospedale Vittorio Veneto
🇮🇹Treviso, Italy
AULSS 2 Marca Trevigiana
🇮🇹Treviso, Italy
IRCCS Sacro Cuore Don Calabria
🇮🇹Verona, Italy
Azienda Ospedaliera Universitaria Integrata di Verona
🇮🇹Verona, Italy
AULSS 3 Serenissima Ospedale "Dell'Angelo"
🇮🇹Venezia, Italy
Azienda Sociosanitaria ASL 1 ,Imperia
🇮🇹Imperia, Italy
Azienda Ospedaliero-Universitaria "Maggiore della Carità" di Novara
🇮🇹Novara, Italy