Retrospective observational cohort study to evaluate the safety and effectiveness of tocilizumab in the treatment of severe COVID-19 pneumonia
Since the appearence of the disease today known as COVID-19 there has been multiple interventions to try to gain knowledge on the subject and obtain a benefitial effect treating this condition. Tocilizumab, a monoclonal antibody targeting IL-6 receptor has arised as an alternative for the treament of COVID-19 pneumonia. It is a drug used for the treatment of rhemautoid arthritis and other autoimmune diseases as well as approved in recent years for the treatment of the cytokine release syndrome (CRS) in CAR-T therapy. It is based in this last premise that the benefitial effect on COVID-19 pneumonia has been sought of. According to investigation into the physiopathology of the virus, it is supposed to trigger the inflamattory cascade that generates damage to lungs and creates the most severe cases of the disease. These findings could imply that tocilizumab may serve to interrupt this cytokine storm and prevent the progression of the disease. The aim of the study is to evaluate the effectiveness and safety of tocilizumab in the treatment of severe cases of COVID-19. For that purpose, an observational retrospective cohort study has been designed comparing two populations that share the same indication for the treatment with tocilizumab. One having received the drug and the other in a close previous period of time that has not received it because of lack of availability or generalisation of its use. Mortality will be assesed as well as other variables such as need for mechanical ventilation and adverse effects of tocilizumab.
Study Type
OBSERVATIONAL
Enrollment
300
Tocilizumab received as a single intravenous infusion over the period of 60 minutes. Dose of 8 mg/kg, maximum dose of 800 mg.
Hospital Italiano de Buenos AIres
Buenos Aires, Buenos Aires F.D., Argentina
RECRUITING28-day mortality
28-day mortality
Time frame: 28 days from hospital admission
Percentage of patients in invasive mechanical ventilation at day 28
Percentage of patients that received invasive mechanical ventilation at day 28 following hospital admission.
Time frame: 28 days from hospital admission
Clinical status during follow-up at 28th day
Ordinal outcome with seven mutually exclusive categories to describe the patient's clinical status during follow-up. The six categories are: (1) Discharged or ready for discharge; (2) Admitted to non-ICU ward without oxygen; (3) admitted to non-ICU ward but requiring supplemental oxygen; (4) admitted to ICU or non ICU ward requiring high flow nasal canula or other non invasive mechanical ventilation; (5) admitted to ICU ward requiring invasive mechanical ventilation (6) admitted to ICU ward requiring extracorporeal membrane oxygenation or invasive mechanical ventilation plus other vital organ support; (7) death
Time frame: 28th day from hospital admission
Mortality rate
Time frame: Days 14 and 21
Percentage of patients in invasive mechanical ventilation at day 14 and 21
Time frame: Days 14 and 21
Percentage of patients with hospital discharge at day 7, 14, 21 and 28
Time frame: Days 7, 14, 21 and 28
Time to hospital discharge
Time from hospital admission to hospital discharge
Time frame: Up to 60 days
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Percentage of patients admitted to ICU-ward at day 28
Percentage of patients admitted to ICU-ward at day 28 from hospital admission
Time frame: 28th day from hospital admission
Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status
Time frame: Up to 60 days
Percentage of patients with need of tracheostomy at day 28 of hospital admission
Time frame: 28th day from hospital admission
Time to mechanical ventilation from hospital admission
Time frame: Up to 28 days
Days of ICU admission
Time frame: Up to 60 days
Time to ICU discharge from hospital admission
Time to ICU discharge from hospital admission in the patients subgroup that required ICU admission.
Time frame: Up to 60 days
Percentage of patients with adverse effects / serious adverse effects
Time frame: Up to 28 days
Percentage of superimposed infections
Time frame: 28th day from hospital admission