Secondary Outcomes
Measure: A composite outcome of death or ICU admission or mechanical ventilation at day 28
Time: 28 days
Description: ICU admission, mechanical ventilation, death or consent withdrawal
Measure: Time to treatment failure
Time: 28 days
Measure: Overall survival at days 14 and 28
Time: 14 and 28 days
Measure: Cumulative incidence of ICU admission rate at days 14 and 28
Time: 14 and 28 days
Measure: Cumulative incidence of mechanical ventilation at days 14 and 28
Time: 14 and 28 days
Measure: Duration of hospital stay
Time: 28 days
Measure: Duration of ICU stay
Time: 28 days
Measure: Duration of mechanical ventilation
Time: 28 days
Measure: Duration of non-invasive ventilation
Time: 28 days
Measure: Secondary hemophagocytic syndrome rate
Time: 28 days
Measure: Cumulative incidence nosocomial infection rate at days 14 and 28
Time: 14 and 28 days
Measure: Incidence of discontinuation of oxygen supplementation at days 14 and 28
Time: 14 and 28 days
Measure: Rate of grade 1-2 and 3-5 emerging adverse events at day 28
Time: 28 days
Measure: Cumulative dose of methylprednisolone at days 14 and 28
Time: 14 and 28 days
Measure: Change in PaO2/FiO2 ratio from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in interleukin 6 levels [pg/mL] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in d-dimer levels [ng/mL] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in fibrinogen levels [mg/dL] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in ferritin levels [ng/mL] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in C reactive protein levels [mg/L] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in alanine aminotransferase [U/L] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in aspartate aminotransferase [U/L] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in creatinine levels [mg/dL] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in glucose levels [mg/dL] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in hemoglobin levels [g/dL] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in platelet count [x10ˆ3/mmˆ3] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in absolute neutrophil count [x10ˆ3/mmˆ3] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in absolute neutrophil count [/mmˆ3] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in absolute lymphocyte count [/mmˆ3] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in prothrombin time ratio from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in partial thromboplastin time ratio from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in bilirubin [mg/dl] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in lactate dehydrogenase [U/L] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in CPK-MB [ng/mL] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in troponin [ng/mL] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in von Willebrand factor antigen level (VWF:Ag) [%] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in von Willebrand factor activity (ristocetin cofactor) [%] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in ADAMTS-13 [%] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in von Willebrand multimeters from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in plasminogen activator inhibitor-1 levels [ng/mL] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in E-selectin levels [ng/mL] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in P-selectin levels [ng/mL] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in endothelin [fmol/mL] from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in circulating microparticles from baseline to days 14 and 28
Time: 14 and 28 days
Measure: Change in thromboelastography from baseline to days 14 and 28
Time: 14 and 28 days