Created at Source Raw Value Validated value
June 25, 2024, noon usa

inclusion criteria: * male and female patients aged 18-80 years inclusive at screening. * clinically diagnosed with the sars-cov-2 virus by polymerase chain reaction (pcr) or by other approved diagnostic methodology within 7 days prior to randomization. * hospitalized with covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan), taken within 5 days prior to randomization (within 24 hours in patients in the netherlands). * impaired respiratory function, defined as peripheral oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) \<300 millimeter of mercury (mmhg) at screening. for cities located at altitudes greater than 2500 m above sea level, these will be substituted with spo2 \<90% and pao2/fio2 \<250 mmhg. * apache ii score of ≥10 at screening. * c-reactive protein (crp) ≥20 mg/l and/or ferritin level ≥600 μg/l at screening. * body mass index of ≥18 to \<40kg/m2 at screening.

inclusion criteria: * male and female patients aged 18-80 years inclusive at screening. * clinically diagnosed with the sars-cov-2 virus by polymerase chain reaction (pcr) or by other approved diagnostic methodology within 7 days prior to randomization. * hospitalized with covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan), taken within 5 days prior to randomization (within 24 hours in patients in the netherlands). * impaired respiratory function, defined as peripheral oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) \<300 millimeter of mercury (mmhg) at screening. for cities located at altitudes greater than 2500 m above sea level, these will be substituted with spo2 \<90% and pao2/fio2 \<250 mmhg. * apache ii score of ≥10 at screening. * c-reactive protein (crp) ≥20 mg/l and/or ferritin level ≥600 μg/l at screening. * body mass index of ≥18 to \<40kg/m2 at screening.

Dec. 1, 2021, 11 p.m. usa

inclusion criteria: male and female patients aged 18-80 years inclusive at screening. clinically diagnosed with the sars-cov-2 virus by polymerase chain reaction (pcr) or by other approved diagnostic methodology within 7 days prior to randomization. hospitalized with covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan), taken within 5 days prior to randomization (within 24 hours in patients in the netherlands). impaired respiratory function, defined as peripheral oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) <300 millimeter of mercury (mmhg) at screening. for cities located at altitudes greater than 2500 m above sea level, these will be substituted with spo2 <90% and pao2/fio2 <250 mmhg. apache ii score of ≥10 at screening. c-reactive protein (crp) ≥20 mg/l and/or ferritin level ≥600 μg/l at screening. body mass index of ≥18 to <40kg/m2 at screening.

inclusion criteria: male and female patients aged 18-80 years inclusive at screening. clinically diagnosed with the sars-cov-2 virus by polymerase chain reaction (pcr) or by other approved diagnostic methodology within 7 days prior to randomization. hospitalized with covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan), taken within 5 days prior to randomization (within 24 hours in patients in the netherlands). impaired respiratory function, defined as peripheral oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) <300 millimeter of mercury (mmhg) at screening. for cities located at altitudes greater than 2500 m above sea level, these will be substituted with spo2 <90% and pao2/fio2 <250 mmhg. apache ii score of ≥10 at screening. c-reactive protein (crp) ≥20 mg/l and/or ferritin level ≥600 μg/l at screening. body mass index of ≥18 to <40kg/m2 at screening.

Oct. 26, 2020, 11:31 p.m. usa

inclusion criteria - male and female patients aged 18-80 years inclusive at screening - clinically diagnosed with the sars-cov-2 virus by polymerase chain reaction (pcr) or by other approved diagnostic methodology within 7 days prior to randomization - hospitalized with covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan), taken within 5 days prior to randomization (within 24 hours in patients in the netherlands) - impaired respiratory function, defined as peripheral oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) <300 millimeter of mercury (mmhg) at screening. for cities located at altitudes greater than 2500 m above sea level, these will be substituted with spo2 <90% and pao2/fio2 <250 mmhg. - apache ii score of ≥10 at screening - c-reactive protein (crp) ≥20 mg/l and/or ferritin level ≥600 μg/l at screening - body mass index of ≥18 to <40kg/m2 at screening exclusion criteria - suspected active or chronic bacterial (including mycobacterium tuberculosis), fungal, viral, or other infection (besides sars-cov-2) - in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment - intubated prior to randomization - previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of hydroxychloroquine, chloroquine or corticosteroids: for covid-19 infection, ongoing corticosteroid treatment is permitted at doses as per local soc for non-covid-19 disorders, ongoing corticosteroid treatment is permitted at doses up to and including prednisolone 10 mg daily or equivalent in patients in the netherlands only, the use of hydroxychloroquine and/or chloroquine in the past 2 weeks are exclusionary - serum alanine transaminase (alt) or aspartate transaminase (ast) >5 times upper limit of normal detected within 24 hours at screening or at baseline (according to local laboratory reference ranges) or other evidence if severe hepatic impairment (child-pugh class c) - absolute peripheral blood neutrophil count of ≤1000/mm3 - estimated gfr (egfr) ≤30 ml/min/1.73m2 (based on ckd-epi formula) - patients currently being treated with drugs known to be strong or moderate inducers of isoenzyme cyp2c9 and/or strong inhibitors of cyp2c9 and/or strong inducers of cytochrome p450, family 3, subfamily a (cyp3a) and the treatment cannot be discontinued or switched to a different medication prior to starting study treatment - patients with innate or acquired immunodeficiencies - patients who have undergone solid organ or stem cell transplantation

inclusion criteria - male and female patients aged 18-80 years inclusive at screening - clinically diagnosed with the sars-cov-2 virus by polymerase chain reaction (pcr) or by other approved diagnostic methodology within 7 days prior to randomization - hospitalized with covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan), taken within 5 days prior to randomization (within 24 hours in patients in the netherlands) - impaired respiratory function, defined as peripheral oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) <300 millimeter of mercury (mmhg) at screening. for cities located at altitudes greater than 2500 m above sea level, these will be substituted with spo2 <90% and pao2/fio2 <250 mmhg. - apache ii score of ≥10 at screening - c-reactive protein (crp) ≥20 mg/l and/or ferritin level ≥600 μg/l at screening - body mass index of ≥18 to <40kg/m2 at screening exclusion criteria - suspected active or chronic bacterial (including mycobacterium tuberculosis), fungal, viral, or other infection (besides sars-cov-2) - in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment - intubated prior to randomization - previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of hydroxychloroquine, chloroquine or corticosteroids: for covid-19 infection, ongoing corticosteroid treatment is permitted at doses as per local soc for non-covid-19 disorders, ongoing corticosteroid treatment is permitted at doses up to and including prednisolone 10 mg daily or equivalent in patients in the netherlands only, the use of hydroxychloroquine and/or chloroquine in the past 2 weeks are exclusionary - serum alanine transaminase (alt) or aspartate transaminase (ast) >5 times upper limit of normal detected within 24 hours at screening or at baseline (according to local laboratory reference ranges) or other evidence if severe hepatic impairment (child-pugh class c) - absolute peripheral blood neutrophil count of ≤1000/mm3 - estimated gfr (egfr) ≤30 ml/min/1.73m2 (based on ckd-epi formula) - patients currently being treated with drugs known to be strong or moderate inducers of isoenzyme cyp2c9 and/or strong inhibitors of cyp2c9 and/or strong inducers of cytochrome p450, family 3, subfamily a (cyp3a) and the treatment cannot be discontinued or switched to a different medication prior to starting study treatment - patients with innate or acquired immunodeficiencies - patients who have undergone solid organ or stem cell transplantation