|drug1037||Placebo solution Wiki||0.71|
|drug1404||Tocilizumab 180 MG/ML Wiki||0.71|
|D045169||Severe Acute Respiratory Syndrome NIH||0.04|
|D018352||Coronavirus Infections NIH||0.03|
There are 2 clinical trials
This is a double-blind, randomized, placebo-controlled, phase IIb clinical trial to assess the efficacy and safety of injectable methylprednisolone sodium succinate (MP) in patients with severe acute respiratory syndrome (SARS) in COVID-19 infection. A total of 420 individuals of both sexes, aged over 18 years old, with symptoms suggestive or confirmed diagnosis of severe acute respiratory syndrome (SARS), hospitalized at the Hospital and Pronto-Socorro Delphina Rinaldi Abdel Aziz (HPSDRAA), with clinical and radiological findings suggestive of SARS-CoV2 infection, will be randomized at a 1:1 ration to receive either MPS (0.5mg/kg of weight, twice daily, for 5 days) or placebo (saline solution, twice daily, for 5 days).
Description: Mortality rate on day 28, after randomizationMeasure: Mortality rate at day 28 Time: on day 28, after randomization
Description: Number of patients with diagnosis of early onset of SARSMeasure: Proportion of patients with SARS Time: after randomization, up to 7 days.
Description: Proportion of patient that died on days 7, 14 and 28.Measure: Mortality rate on days 7, 14 and 28 Time: after randomization, up to 28 days.
Description: proportion of patients requiring orotracheal intubationMeasure: Incidence of orotracheal intubation Time: after randomization, up to 7 days.
Description: Proportion of patients with oxygenation index (PaO2 / FiO2) < 100 in 7 days.Measure: Change in oxygenation index Time: after randomization, up to 7 days.
This study compare the efficacy and safety of tocilizumab versus methylprednisolone in the cytokine release syndrome of patients with COVID-19
Description: A seven-category ordinal scale consisting of: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.Measure: Patient clinical status 15 days after randomization Time: 15 days after randomization
Description: Improvement in PaO2/FIO2Measure: Improving oxygenation Time: 15 days
Description: Improvement in the computed tomography between D0 and D10 after randomizationMeasure: Thorax CT improvement Time: 10 days
Description: Duration o ICU stay in daysMeasure: ICU length of stay Time: 28 days
Description: Days of mechanical ventilationMeasure: Duration of mechanical ventilation Time: 28 days
Description: AKI according to Kidney Disease Improving Global Outcomes (KDIGO)Measure: Incidence of acute kidney (AKI) with necessity of renal replacement therapy Time: 15 days