Created at Source Raw Value Validated value
March 9, 2021, 12:31 a.m. usa

None

None

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

- progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator. - multiple organ failure according to the investigator's judgement or a sequential organ failure assessment (sofa score) >10 if in the icu. - extracorporeal membrane oxygenation (ecmo) hemofiltration/dialysis or high-dose (>0.15 micrograms [mcg]/kilograms [kg]/min) noradrenaline (or equivalent) or more than one vasopressor. - current serious or uncontrolled medical condition (for example: significant pulmonary disease [such as severe chronic obstructive pulmonary disease (copd) or pulmonary fibrosis], heart failure [new york heart association {nyha} class iii or higher], significant renal dysfunction, acute myocardial infarction or acute cerebrovascular accident within the last 3 months) or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study. - untreated systemic bacterial, fungal, viral, or other infection (other than sars-cov-2). - known active tuberculosis (tb), history of untreated or incompletely treated active or latent tb, suspected or known extrapulmonary tb. - known human immunodeficiency virus (hiv) regardless of immunological status. - known hepatitis b surface antigen (hbsag) and/or anti-hepatitis c virus (hcv) positive. - currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy. - received monoclonal antibody therapy (e.g. tocilizumab, sarilumab) within the past 3 months prior to randomization, including intravenous immunoglobulin, or planned to be received, during the study. - received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, janus kinase (jak) inhibitors (e.g. baricitinib, tofacitinib, upadacitinib) within the last 3 months prior to randomization or planned to be received during the study. - history of allergic reaction, including anaphylaxis to any previous treatment with an anti-gm-csf therapy. - received covid-19 convalescent plasma within 48 hours of randomization. - currently receiving chronic oral corticosteroids for a non-covid-19 related condition in a dose higher than prednisone 10 milligrams (mg) or equivalent per day. - treatment with an investigational drug within 30 days of randomization. - participating in other drug clinical trials, including for covid-19. - aspartate aminotransferase (ast) or alanine aminotransferase (alt) >5 times uln. - platelets <50,000/cubic millimeters (mm^3) - hemoglobin <=9 grams per deciliter (g/dl) - absolute neutrophil count (anc) <1.5 times 10^9/l (neutropenia >= grade 2) - estimated glomerular filtration rate (gfr) <=30 milliliters (ml)/min/1.73 meter square (/m^2). - pregnant or breastfeeding females.

- progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator. - multiple organ failure according to the investigator's judgement or a sequential organ failure assessment (sofa score) >10 if in the icu. - extracorporeal membrane oxygenation (ecmo) hemofiltration/dialysis or high-dose (>0.15 micrograms [mcg]/kilograms [kg]/min) noradrenaline (or equivalent) or more than one vasopressor. - current serious or uncontrolled medical condition (for example: significant pulmonary disease [such as severe chronic obstructive pulmonary disease (copd) or pulmonary fibrosis], heart failure [new york heart association {nyha} class iii or higher], significant renal dysfunction, acute myocardial infarction or acute cerebrovascular accident within the last 3 months) or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study. - untreated systemic bacterial, fungal, viral, or other infection (other than sars-cov-2). - known active tuberculosis (tb), history of untreated or incompletely treated active or latent tb, suspected or known extrapulmonary tb. - known human immunodeficiency virus (hiv) regardless of immunological status. - known hepatitis b surface antigen (hbsag) and/or anti-hepatitis c virus (hcv) positive. - currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy. - received monoclonal antibody therapy (e.g. tocilizumab, sarilumab) within the past 3 months prior to randomization, including intravenous immunoglobulin, or planned to be received, during the study. - received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, janus kinase (jak) inhibitors (e.g. baricitinib, tofacitinib, upadacitinib) within the last 3 months prior to randomization or planned to be received during the study. - history of allergic reaction, including anaphylaxis to any previous treatment with an anti-gm-csf therapy. - received covid-19 convalescent plasma within 48 hours of randomization. - currently receiving chronic oral corticosteroids for a non-covid-19 related condition in a dose higher than prednisone 10 milligrams (mg) or equivalent per day. - treatment with an investigational drug within 30 days of randomization. - participating in other drug clinical trials, including for covid-19. - aspartate aminotransferase (ast) or alanine aminotransferase (alt) >5 times uln. - platelets <50,000/cubic millimeters (mm^3) - hemoglobin <=9 grams per deciliter (g/dl) - absolute neutrophil count (anc) <1.5 times 10^9/l (neutropenia >= grade 2) - estimated glomerular filtration rate (gfr) <=30 milliliters (ml)/min/1.73 meter square (/m^2). - pregnant or breastfeeding females.