Created at Source Raw Value Validated value
Feb. 25, 2022, noon oms

Those who are on high flow oxygen or noninvasive or invasive mechanical ventilation or ECMO at the time of randomization <br/ > Those on steroids for more than 10 days for any indication <br/ > Patient has received baricitinib or any other immunomodulatory agent such as tumor <br/ > necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication within 4 weeks of the 1st dose of baricitinib <br/ > Patient has inability to supply direct informed consent or if it was not possible to obtain from Next of Kin or Independent Healthcare Provider on behalf of patient <br/ > Contraindications to study drugs, including history of hypersensitivity to the active substances or any of the excipients <br/ > Suspected or known active infections including but not limited to tuberculosis, hepatitis B or C (no blood screening required), herpes zoster or HIV. <br/ > Current or past (within 3 months) participation in any interventional clinical trial including COVID-19-related disease trials (observational studies allowed) <br/ > Patient moribund at presentation or screening or expected survival is <24h <br/ > Pregnant or lactating women at screening (or unwillingness to adhere to pregnancy <br/ > advice in protocol) <br/ > Either alanine transaminase or aspartate transaminase (ALT or AST) > 5 times the upper <br/ > limit of normal (ULN) <br/ > Stage 4 severe chronic kidney disease or requiring dialysis (i.e. Cockcroft Gault estimated <br/ > creatinine clearance < 30 ml /min) <br/ > Currently receiving or ever received hyperimmune globulin, convalescent plasma or <br/ > intravenous immunoglobulin [IVIg]) for COVID-19 <br/ > Patient has received neutralizing antibodies, such as bamlanivimab-etesevimab, <br/ > casirivimab-imdevimab and sotrovimab for COVID-19. <br/ > Patient has history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] <br/ > and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or has a history <br/ > of recurrent ( >1) VTE <br/ > Current diagnosis of active malignancy that, in the opinion of the investigator, could <br/ > constitute a risk when taking investigational product <br/ > Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern

Those who are on high flow oxygen or noninvasive or invasive mechanical ventilation or ECMO at the time of randomization <br/ > Those on steroids for more than 10 days for any indication <br/ > Patient has received baricitinib or any other immunomodulatory agent such as tumor <br/ > necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication within 4 weeks of the 1st dose of baricitinib <br/ > Patient has inability to supply direct informed consent or if it was not possible to obtain from Next of Kin or Independent Healthcare Provider on behalf of patient <br/ > Contraindications to study drugs, including history of hypersensitivity to the active substances or any of the excipients <br/ > Suspected or known active infections including but not limited to tuberculosis, hepatitis B or C (no blood screening required), herpes zoster or HIV. <br/ > Current or past (within 3 months) participation in any interventional clinical trial including COVID-19-related disease trials (observational studies allowed) <br/ > Patient moribund at presentation or screening or expected survival is <24h <br/ > Pregnant or lactating women at screening (or unwillingness to adhere to pregnancy <br/ > advice in protocol) <br/ > Either alanine transaminase or aspartate transaminase (ALT or AST) > 5 times the upper <br/ > limit of normal (ULN) <br/ > Stage 4 severe chronic kidney disease or requiring dialysis (i.e. Cockcroft Gault estimated <br/ > creatinine clearance < 30 ml /min) <br/ > Currently receiving or ever received hyperimmune globulin, convalescent plasma or <br/ > intravenous immunoglobulin [IVIg]) for COVID-19 <br/ > Patient has received neutralizing antibodies, such as bamlanivimab-etesevimab, <br/ > casirivimab-imdevimab and sotrovimab for COVID-19. <br/ > Patient has history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] <br/ > and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or has a history <br/ > of recurrent ( >1) VTE <br/ > Current diagnosis of active malignancy that, in the opinion of the investigator, could <br/ > constitute a risk when taking investigational product <br/ > Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern