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

1. patients with 'mild' or 'severe' covid-19 disease severity, as defined by latest comprehensive guidelines for management of covid-19 patients, directorate general of health services, mohfw, goi at the time of randomization. this includes any one or more of the following 1. peripheral blood oxygen saturation ≥94% or \<90% 2. respiratory rate or \<24 or ≥30 breaths per minute 2. first positive rt-pcr more than 7 days prior to treatment administration 3. patients with evidence of other serious infectious, malignant, autoimmune, kidney, hepatic, cardiovascular or other systemic disease and/or laboratory abnormality, which, in the opinion of the investigator, prevent the patient from participating in the study 4. subjects with chronic liver disease (child pugh class b or c) and chronic renal disease (gfr\<30ml/min). 5. renal dysfunction \[serum creatinine \> 2.5 times of uln or calculated creatinine clearance \< 30ml/min\], liver dysfunction \[total bilirubin \> 3times uln \& ast/alt \> 5times uln\]. 6. chronic systemic glucocorticoid treatment or any immunosuppressive treatment 7. history of human immunodeficiency virus (hiv) or active infection with hepatitis b virus (hbv) or hepatitis c virus (hcv) 8. pregnant and lactating patients. 9. patients who require il-6 inhibitors for management of inflammation at the time of study entry. 10. subject has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. 11. hospital discharge is anticipated in ≤ 24 hours or anticipated transfer to another hospital which is not a study site within 72 hours. 12. patients that are currently or have participated in such studies participating in other clinical studies with investigational drug, biological agent or device within 1 month or within 5 half-lives (of the drug/biologic) prior to randomization (whichever is longer).

1. patients with 'mild' or 'severe' covid-19 disease severity, as defined by latest comprehensive guidelines for management of covid-19 patients, directorate general of health services, mohfw, goi at the time of randomization. this includes any one or more of the following 1. peripheral blood oxygen saturation ≥94% or \<90% 2. respiratory rate or \<24 or ≥30 breaths per minute 2. first positive rt-pcr more than 7 days prior to treatment administration 3. patients with evidence of other serious infectious, malignant, autoimmune, kidney, hepatic, cardiovascular or other systemic disease and/or laboratory abnormality, which, in the opinion of the investigator, prevent the patient from participating in the study 4. subjects with chronic liver disease (child pugh class b or c) and chronic renal disease (gfr\<30ml/min). 5. renal dysfunction \[serum creatinine \> 2.5 times of uln or calculated creatinine clearance \< 30ml/min\], liver dysfunction \[total bilirubin \> 3times uln \& ast/alt \> 5times uln\]. 6. chronic systemic glucocorticoid treatment or any immunosuppressive treatment 7. history of human immunodeficiency virus (hiv) or active infection with hepatitis b virus (hbv) or hepatitis c virus (hcv) 8. pregnant and lactating patients. 9. patients who require il-6 inhibitors for management of inflammation at the time of study entry. 10. subject has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. 11. hospital discharge is anticipated in ≤ 24 hours or anticipated transfer to another hospital which is not a study site within 72 hours. 12. patients that are currently or have participated in such studies participating in other clinical studies with investigational drug, biological agent or device within 1 month or within 5 half-lives (of the drug/biologic) prior to randomization (whichever is longer).

Dec. 21, 2022, 8 a.m. usa

patients with 'mild' or 'severe' covid-19 disease severity, as defined by latest comprehensive guidelines for management of covid-19 patients, directorate general of health services, mohfw, goi at the time of randomization. this includes any one or more of the following peripheral blood oxygen saturation ≥94% or <90% respiratory rate or <24 or ≥30 breaths per minute first positive rt-pcr more than 7 days prior to treatment administration patients with evidence of other serious infectious, malignant, autoimmune, kidney, hepatic, cardiovascular or other systemic disease and/or laboratory abnormality, which, in the opinion of the investigator, prevent the patient from participating in the study subjects with chronic liver disease (child pugh class b or c) and chronic renal disease (gfr<30ml/min). renal dysfunction [serum creatinine > 2.5 times of uln or calculated creatinine clearance < 30ml/min], liver dysfunction [total bilirubin > 3times uln & ast/alt > 5times uln]. chronic systemic glucocorticoid treatment or any immunosuppressive treatment history of human immunodeficiency virus (hiv) or active infection with hepatitis b virus (hbv) or hepatitis c virus (hcv) pregnant and lactating patients. patients who require il-6 inhibitors for management of inflammation at the time of study entry. subject has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. hospital discharge is anticipated in ≤ 24 hours or anticipated transfer to another hospital which is not a study site within 72 hours. patients that are currently or have participated in such studies participating in other clinical studies with investigational drug, biological agent or device within 1 month or within 5 half-lives (of the drug/biologic) prior to randomization (whichever is longer).

patients with 'mild' or 'severe' covid-19 disease severity, as defined by latest comprehensive guidelines for management of covid-19 patients, directorate general of health services, mohfw, goi at the time of randomization. this includes any one or more of the following peripheral blood oxygen saturation ≥94% or <90% respiratory rate or <24 or ≥30 breaths per minute first positive rt-pcr more than 7 days prior to treatment administration patients with evidence of other serious infectious, malignant, autoimmune, kidney, hepatic, cardiovascular or other systemic disease and/or laboratory abnormality, which, in the opinion of the investigator, prevent the patient from participating in the study subjects with chronic liver disease (child pugh class b or c) and chronic renal disease (gfr<30ml/min). renal dysfunction [serum creatinine > 2.5 times of uln or calculated creatinine clearance < 30ml/min], liver dysfunction [total bilirubin > 3times uln & ast/alt > 5times uln]. chronic systemic glucocorticoid treatment or any immunosuppressive treatment history of human immunodeficiency virus (hiv) or active infection with hepatitis b virus (hbv) or hepatitis c virus (hcv) pregnant and lactating patients. patients who require il-6 inhibitors for management of inflammation at the time of study entry. subject has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. hospital discharge is anticipated in ≤ 24 hours or anticipated transfer to another hospital which is not a study site within 72 hours. patients that are currently or have participated in such studies participating in other clinical studies with investigational drug, biological agent or device within 1 month or within 5 half-lives (of the drug/biologic) prior to randomization (whichever is longer).