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

* clinically-significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol * treatment with ifn or other immunomodulatory/immunosuppressive agent within 12 months before screening. * respiratory compromise requiring ventilatory support other than nasal cannula (mask, bipap or intubation and mechanical ventilation) * history of treatment with any of the following medications within five half-lives or 30 days before administration of the study drug (whichever is longer): anti-il-6, anti-il6r antagonists, janus kinase inhibitors, ustekinumab (anti-il-12/23), or anti il-23 agents (guselkumab). * life threatening sae during the screening period * pregnant or nursing females * platelet count \<90,000 cells/mm3 * wbc count \<3,000 cells/mm3 * anc \<1,500 cells/mm3 * hb \<11 g/dl for women and \<12 g/dl for men * crcl \< 50 ml/min * bilirubin level ≥ 1.5x uln * inr ≥1.5 (except in the setting of concomitant anticoagulant use) * crp \> 200 mg/l * clinically-relevant alcohol or drug abuse within 12 months of screening * known hypersensitivity to interferons * current or planned participation in an investigational new drug (ind) trial from 30-days prior to randomization through day 14 post treatment

* clinically-significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol * treatment with ifn or other immunomodulatory/immunosuppressive agent within 12 months before screening. * respiratory compromise requiring ventilatory support other than nasal cannula (mask, bipap or intubation and mechanical ventilation) * history of treatment with any of the following medications within five half-lives or 30 days before administration of the study drug (whichever is longer): anti-il-6, anti-il6r antagonists, janus kinase inhibitors, ustekinumab (anti-il-12/23), or anti il-23 agents (guselkumab). * life threatening sae during the screening period * pregnant or nursing females * platelet count \<90,000 cells/mm3 * wbc count \<3,000 cells/mm3 * anc \<1,500 cells/mm3 * hb \<11 g/dl for women and \<12 g/dl for men * crcl \< 50 ml/min * bilirubin level ≥ 1.5x uln * inr ≥1.5 (except in the setting of concomitant anticoagulant use) * crp \> 200 mg/l * clinically-relevant alcohol or drug abuse within 12 months of screening * known hypersensitivity to interferons * current or planned participation in an investigational new drug (ind) trial from 30-days prior to randomization through day 14 post treatment

April 11, 2021, 12:31 a.m. usa

- clinically-significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol - treatment with ifn or other immunomodulatory/immunosuppressive agent within 12 months before screening. - respiratory compromise requiring ventilatory support other than nasal cannula (mask, bipap or intubation and mechanical ventilation) - history of treatment with any of the following medications within five half-lives or 30 days before administration of the study drug (whichever is longer): anti-il-6, anti-il6r antagonists, janus kinase inhibitors, ustekinumab (anti-il-12/23), or anti il-23 agents (guselkumab). - life threatening sae during the screening period - pregnant or nursing females - platelet count <90,000 cells/mm3 - wbc count <3,000 cells/mm3 - anc <1,500 cells/mm3 - hb <11 g/dl for women and <12 g/dl for men - crcl < 50 ml/min - bilirubin level ≥ 1.5x uln - inr ≥1.5 (except in the setting of concomitant anticoagulant use) - crp > 200 mg/l - clinically-relevant alcohol or drug abuse within 12 months of screening - known hypersensitivity to interferons - current or planned participation in an investigational new drug (ind) trial from 30-days prior to randomization through day 14 post treatment

- clinically-significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol - treatment with ifn or other immunomodulatory/immunosuppressive agent within 12 months before screening. - respiratory compromise requiring ventilatory support other than nasal cannula (mask, bipap or intubation and mechanical ventilation) - history of treatment with any of the following medications within five half-lives or 30 days before administration of the study drug (whichever is longer): anti-il-6, anti-il6r antagonists, janus kinase inhibitors, ustekinumab (anti-il-12/23), or anti il-23 agents (guselkumab). - life threatening sae during the screening period - pregnant or nursing females - platelet count <90,000 cells/mm3 - wbc count <3,000 cells/mm3 - anc <1,500 cells/mm3 - hb <11 g/dl for women and <12 g/dl for men - crcl < 50 ml/min - bilirubin level ≥ 1.5x uln - inr ≥1.5 (except in the setting of concomitant anticoagulant use) - crp > 200 mg/l - clinically-relevant alcohol or drug abuse within 12 months of screening - known hypersensitivity to interferons - current or planned participation in an investigational new drug (ind) trial from 30-days prior to randomization through day 14 post treatment

Dec. 13, 2020, 12:31 a.m. usa

- clinically-significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol - treatment with ifn or other immunomodulatory/immunosuppressive agent within 12 months before screening. - respiratory compromise requiring ventilatory support other than nasal cannula (mask, bipap or intubation and mechanical ventilation) - history of treatment with any of the following medications within five half-lives or 30 days before administration of the study drug (whichever is longer): anti-il-6, anti-il6r antagonists, janus kinase inhibitors, ustekinumab (anti-il-12/23), or anti il-23 agents (guselkumab). - life threatening sae during the screening period - pregnant or nursing females - platelet count <90,000 cells/mm3 - wbc count <3,000 cells/mm3 - anc <1,500 cells/mm3 - hb <11 g/dl for women and <12 g/dl for men - crcl < 50 ml/min - bilirubin level ≥ 2.5 mg/dl - alb <3.5 g/dl - inr ≥1.5 (except in the setting of concomitant anticoagulant use) - crp > 200 mg/l - clinically-relevant alcohol or drug abuse within 12 months of screening - known hypersensitivity to interferons - current or planned participation in an investigational new drug (ind) trial from 30-days prior to randomization through day 14 post treatment

- clinically-significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol - treatment with ifn or other immunomodulatory/immunosuppressive agent within 12 months before screening. - respiratory compromise requiring ventilatory support other than nasal cannula (mask, bipap or intubation and mechanical ventilation) - history of treatment with any of the following medications within five half-lives or 30 days before administration of the study drug (whichever is longer): anti-il-6, anti-il6r antagonists, janus kinase inhibitors, ustekinumab (anti-il-12/23), or anti il-23 agents (guselkumab). - life threatening sae during the screening period - pregnant or nursing females - platelet count <90,000 cells/mm3 - wbc count <3,000 cells/mm3 - anc <1,500 cells/mm3 - hb <11 g/dl for women and <12 g/dl for men - crcl < 50 ml/min - bilirubin level ≥ 2.5 mg/dl - alb <3.5 g/dl - inr ≥1.5 (except in the setting of concomitant anticoagulant use) - crp > 200 mg/l - clinically-relevant alcohol or drug abuse within 12 months of screening - known hypersensitivity to interferons - current or planned participation in an investigational new drug (ind) trial from 30-days prior to randomization through day 14 post treatment

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

- clinically-significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol - treatment with ifn or other immunomodulatory/immunosuppressive agent within 12 months before screening. - respiratory compromise requiring ventilatory support other than nasal cannula (mask, bipap or intubation and mechanical ventilation) - history of treatment with any of the following medications within five half-lives or 30 days before administration of the study drug (whichever is longer): anti-il-6, anti-il6r antagonists, janus kinase inhibitors, ustekinumab (anti-il-12/23), or anti il-23 agents (guselkumab). - life threatening sae during the screening period - pregnant or nursing females - platelet count <90,000 cells/mm3 - wbc count <3,000 cells/mm3 - anc <1,500 cells/mm3 - hb <11 g/dl for women and <12 g/dl for men - crcl < 50 ml/min - bilirubin level ≥ 2.5 mg/dl - alb <3.5 g/dl - inr ≥1.5 (except in the setting of concomitant anticoagulant use) - d-dimer > 1500 ng/ml - crp > 200 mg/l - clinically-relevant alcohol or drug abuse within 12 months of screening - known hypersensitivity to interferons - current or planned participation in an investigational new drug (ind) trial from 30-days prior to randomization through day 14 post treatment

- clinically-significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol - treatment with ifn or other immunomodulatory/immunosuppressive agent within 12 months before screening. - respiratory compromise requiring ventilatory support other than nasal cannula (mask, bipap or intubation and mechanical ventilation) - history of treatment with any of the following medications within five half-lives or 30 days before administration of the study drug (whichever is longer): anti-il-6, anti-il6r antagonists, janus kinase inhibitors, ustekinumab (anti-il-12/23), or anti il-23 agents (guselkumab). - life threatening sae during the screening period - pregnant or nursing females - platelet count <90,000 cells/mm3 - wbc count <3,000 cells/mm3 - anc <1,500 cells/mm3 - hb <11 g/dl for women and <12 g/dl for men - crcl < 50 ml/min - bilirubin level ≥ 2.5 mg/dl - alb <3.5 g/dl - inr ≥1.5 (except in the setting of concomitant anticoagulant use) - d-dimer > 1500 ng/ml - crp > 200 mg/l - clinically-relevant alcohol or drug abuse within 12 months of screening - known hypersensitivity to interferons - current or planned participation in an investigational new drug (ind) trial from 30-days prior to randomization through day 14 post treatment