Created at Source Raw Value Validated value
Dec. 26, 2020, 12:31 a.m. usa

- patients requiring invasive (mechanical ventilation) or non-invasive (cpap, bipap for hypoxemia) ventilation or ecmo (note: oxygen supplementation using high flow oxygen systems or low flow oxygen systems would not exclude patients from this study) - intractable metabolic acidosis - cardiogenic pulmonary edema - hypotension requiring use of vasopressors - hyperferritinemia (serum ferritin ≥2,000 mcg/l) - white blood cell count > 50,000/mm3 - participation in another interventional clinical trial for covid-19 therapy - highly immunosuppressive therapy or anti-cancer combination chemotherapy within 24 hours prior to first dose of sargramostim - known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product - previous experience of severe and unexplained side effects during aerosol delivery of any kind of medical product - presence of any preexisting illness that, in the opinion of the investigator, would place the patient at an unreasonably increased risk through participation in this study - pregnant or breastfeeding females - severe or uncontrolled pulmonary comorbid conditions, including systemic steroid dependent asthma, systemic steroid dependent copd, oxygen dependent copd, lung transplant, known interstitial lung disease, or cystic fibrosis

- patients requiring invasive (mechanical ventilation) or non-invasive (cpap, bipap for hypoxemia) ventilation or ecmo (note: oxygen supplementation using high flow oxygen systems or low flow oxygen systems would not exclude patients from this study) - intractable metabolic acidosis - cardiogenic pulmonary edema - hypotension requiring use of vasopressors - hyperferritinemia (serum ferritin ≥2,000 mcg/l) - white blood cell count > 50,000/mm3 - participation in another interventional clinical trial for covid-19 therapy - highly immunosuppressive therapy or anti-cancer combination chemotherapy within 24 hours prior to first dose of sargramostim - known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product - previous experience of severe and unexplained side effects during aerosol delivery of any kind of medical product - presence of any preexisting illness that, in the opinion of the investigator, would place the patient at an unreasonably increased risk through participation in this study - pregnant or breastfeeding females - severe or uncontrolled pulmonary comorbid conditions, including systemic steroid dependent asthma, systemic steroid dependent copd, oxygen dependent copd, lung transplant, known interstitial lung disease, or cystic fibrosis

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

- intubated and supported by mechanical ventilation - intractable metabolic acidosis - cardiogenic pulmonary edema - hypotension requiring use of vasopressors - hyperferritinemia (serum ferritin ≥2,000 mcg/l) - white blood cell count > 50,000/mm3 - participation in another interventional clinical trial for covid-19 therapy - highly immunosuppressive therapy or anti-cancer combination chemotherapy within 24 hours prior to first dose of sargramostim - known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product - previous experience of severe and unexplained side effects during aerosol delivery of any kind of medical product - presence of any preexisting illness that, in the opinion of the investigator, would place the patient at an unreasonably increased risk through participation in this study - pregnant or breastfeeding females

- intubated and supported by mechanical ventilation - intractable metabolic acidosis - cardiogenic pulmonary edema - hypotension requiring use of vasopressors - hyperferritinemia (serum ferritin ≥2,000 mcg/l) - white blood cell count > 50,000/mm3 - participation in another interventional clinical trial for covid-19 therapy - highly immunosuppressive therapy or anti-cancer combination chemotherapy within 24 hours prior to first dose of sargramostim - known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product - previous experience of severe and unexplained side effects during aerosol delivery of any kind of medical product - presence of any preexisting illness that, in the opinion of the investigator, would place the patient at an unreasonably increased risk through participation in this study - pregnant or breastfeeding females