COVID-19 Pneumonia
Conditions
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.
Interventions
DRUGTocilizumab
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
Sponsors
Azienda USL Reggio Emilia - IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed