The COVID-19 pandemic has had a dramatic effect in public health worldwide. In Brazil, there have been more than 2 million confirmed cases and over 75,000 deaths since February 26, 2020. Based on reports of a hyperinflammatory state associated with COVID-19, the use of immunosuppressive drugs may be efficacious in the treatment of this disease. JAK inhibitors have been shown to harness inflammation in a number of different pathologic conditions. The aim of the present study is to evaluate the efficacy and safety of JAK inhibitor ruxolitinib in patients with acute respiratory distress syndrome due to COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5
5 mg P.O. b.i.d. for 14 days. Dose reduction will occur if neutrophils \< 500/mm3 or platelets \<50,000/mm3.
Placebo tablets P.O. b.i.d. for 14 days.
Hospital das Clínicas
São Paulo, Brazil
A composite outcome of death or ICU admission or mechanical ventilation at day 14.
Time frame: 14 days
A composite outcome of death or ICU admission or mechanical ventilation at day 28
Time frame: 28 days
Time to treatment failure
ICU admission, mechanical ventilation, death or consent withdrawal
Time frame: 28 days
Overall survival at days 14 and 28
Time frame: 14 and 28 days
Cumulative incidence of ICU admission rate at days 14 and 28
Time frame: 14 and 28 days
Cumulative incidence of mechanical ventilation at days 14 and 28
Time frame: 14 and 28 days
Duration of hospital stay
Time frame: 28 days
Duration of ICU stay
Time frame: 28 days
Duration of mechanical ventilation
Time frame: 28 days
Duration of non-invasive ventilation
Time frame: 28 days
Secondary hemophagocytic syndrome rate
Time frame: 28 days
Cumulative incidence nosocomial infection rate at days 14 and 28
Time frame: 14 and 28 days
Incidence of discontinuation of oxygen supplementation at days 14 and 28
Time frame: 14 and 28 days
Rate of grade 1-2 and 3-5 emerging adverse events at day 28
Time frame: 28 days
Cumulative dose of methylprednisolone at days 14 and 28
Time frame: 14 and 28 days
Change in PaO2/FiO2 ratio from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in interleukin 6 levels [pg/mL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in d-dimer levels [ng/mL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in fibrinogen levels [mg/dL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in ferritin levels [ng/mL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in C reactive protein levels [mg/L] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in alanine aminotransferase [U/L] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in aspartate aminotransferase [U/L] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in creatinine levels [mg/dL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in glucose levels [mg/dL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in hemoglobin levels [g/dL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in platelet count [x10ˆ3/mmˆ3] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in absolute neutrophil count [x10ˆ3/mmˆ3] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in absolute neutrophil count [/mmˆ3] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in absolute lymphocyte count [/mmˆ3] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in prothrombin time ratio from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in partial thromboplastin time ratio from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in bilirubin [mg/dl] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in lactate dehydrogenase [U/L] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in CPK-MB [ng/mL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in troponin [ng/mL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in von Willebrand factor antigen level (VWF:Ag) [%] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in von Willebrand factor activity (ristocetin cofactor) [%] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in ADAMTS-13 [%] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in von Willebrand multimeters from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in plasminogen activator inhibitor-1 levels [ng/mL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in E-selectin levels [ng/mL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in P-selectin levels [ng/mL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in endothelin [fmol/mL] from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in circulating microparticles from baseline to days 14 and 28
Time frame: 14 and 28 days
Change in thromboelastography from baseline to days 14 and 28
Time frame: 14 and 28 days
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