Randomized, open, single-center, controlled clinical trial, with 2 treatment arms that seeks to demonstrate the effectiveness of tocilizumab against systemic corticosteroids, both treatments added to supportive treatment in patients admitted for COVID-19 with bilateral pneumonia and poor evolution
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Tocilizumab is a humanized recombinant IgG1 monoclonal antibody to human interleukin-6 (IL-6) receptor, produced in Chinese hamster ovary cells by recombinant DNA technology.
Methylprednisolone belongs to a group of medicines called corticosteroids (it works at the cellular level by reducing the production of substances that cause inflammation or allergy).
Clinical Research Platform Biodonostia Health Research Institute
San Sebastián, Guipuzcoa, Spain
Respiratory situation at 24 hours, 3 and 7 days based on the PaO2 / FiO2 ratio that graduates respiratory distress into mild (200-300), moderate (100-200) and severe (<100).
Quantitative variable that will be analyzed as qualitative (better, worse) based on whether there is a change in the graduation described above.
Time frame: 7 days
Immune hyperactivation situation: LDH, D-dimer and ferritin value at 24 hours, 3 and 7 days. Each one is a quantitative variable.
They will be measured as such and also qualitatively (worse, better) independently and together. A worsening of 2 of the 3 variables will be considered "worse"; "Better" if there is improvement in 2 of the 3.
Time frame: 7 days
Mechanical ventilation: qualitative variable (yes or no)
Time frame: 7 days
Combined variable of variables i, iii and in-hospital mortality (this is understood to be: respiratory deterioration or need for mechanical ventilation or in-hospital death)
Time frame: 7 days
Number of patients admitted to the ICU
Time frame: 10 months
Time to admission to the ICU (from the beginning of the trial and from the beginning of the picture)
Time frame: 10 months
Time to the start of mechanical ventilation (from the start of the trial and from the start of the picture)
Time frame: 10 months
Time of admission to ICU
Time frame: 10 months
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Total admission time
Time frame: 10 months
In-hospital mortality
Time frame: 10 months
Mortality at 30 and 60 days
Time frame: 60 days
Respiratory situation at 30 and 60 days according to pulse oximetric O2 saturation, respiratory rate and presence of dyspnea and NYHA grade.
Time frame: 10 months
Documented nosocomial infections
Time frame: 10 months