Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19
Cytokine Release Syndrome, Covid-19
About this trial
This is an interventional treatment trial for Cytokine Release Syndrome focused on measuring Cytokine release syndrome, COVID-19, Tocilizumab, Methylprednisolone, Safety, Efficacy
Eligibility Criteria
Inclusion Criteria:
Men and non-pregnant women over 18 years old COVID diagnosis confirmed by real time polymerase chain reaction (RT-PCR) Pao2 / FIO2 <200 Laboratory: high sensitivity C reactive protein> 5 mg / L; lactic dehydrogenase (LDH ) > 245 U / l; Ferritin> 300; D-dimer> 1500; Interleukin-6> 7.0 pg / ml.
Exclusion Criteria:
- Known sensitivity/Allergy to tocilizumab
- Active tuberculosis
- Pregnancy
- Individuals, in the opinion of the investigators where progression to death is imminent and inevitable in the next 24 hours
Sites / Locations
- Hospital Sao Domingos
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Tocilizumab
Methylprednisolone
Patients will receive Tocilizumab, 8 mg / kg diluted in 100 ml of saline and administered IV for 60 minutes. The dose will be repeated only once 12 hours after the first dose.
Patients will receive methylprednisolone at a dose of 1.5 mg / kg / day divided into 2 daily doses for 7 days. Then they will receive 1 mg / kg / day for another 7 days in two daily doses. Finally 0.5 mg / kg / day for another 7 days.