Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

1. Require invasive mechanical ventilation <br/ >2. Presence of any of the following abnormal laboratory values at screening: o Absolute neutrophil count <1000 mm3 o Platelets <50,000 per mm3 o Hemoglobin <10 g/dL o Aspartate aminotransferase and alanine aminotransferase >5 Ã? ULN o Creatinine >1.5 Ã? ULN <br/ >3. Patients with confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline. <br/ >4. Known active tuberculosis (TB), history of incompletely treated TB or suspected TB (with clinical features like coughing for longer than 3 weeks, hemoptysis, chest pain) or known extrapulmonary TB <br/ >5. Known case of hepatitis B, hepatitis C or HIV infection. <br/ >6. Known hypersensitivity to etanercept or any component of the formulation <br/ >7. Patients having received Remdesivir prior to screening <br/ >8. Patients receiving cytotoxic/immunosuppressant or biologic treatments (such as tumor necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry <br/ >9. Participation in any other clinical trial of an experimental treatment for COVID-19 <br/ >10. Any condition that, in the opinion of the investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the patient at unacceptably high risk from the study.

1. Require invasive mechanical ventilation <br/ >2. Presence of any of the following abnormal laboratory values at screening: o Absolute neutrophil count <1000 mm3 o Platelets <50,000 per mm3 o Hemoglobin <10 g/dL o Aspartate aminotransferase and alanine aminotransferase >5 Ã? ULN o Creatinine >1.5 Ã? ULN <br/ >3. Patients with confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline. <br/ >4. Known active tuberculosis (TB), history of incompletely treated TB or suspected TB (with clinical features like coughing for longer than 3 weeks, hemoptysis, chest pain) or known extrapulmonary TB <br/ >5. Known case of hepatitis B, hepatitis C or HIV infection. <br/ >6. Known hypersensitivity to etanercept or any component of the formulation <br/ >7. Patients having received Remdesivir prior to screening <br/ >8. Patients receiving cytotoxic/immunosuppressant or biologic treatments (such as tumor necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry <br/ >9. Participation in any other clinical trial of an experimental treatment for COVID-19 <br/ >10. Any condition that, in the opinion of the investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the patient at unacceptably high risk from the study.

Nov. 13, 2021, 5:33 p.m. oms

N/A

N/A

May 27, 2021, 12:45 a.m. oms

1. Require invasive mechanical ventilation <br/ >2. Presence of any of the following abnormal laboratory values at screening: o Absolute neutrophil count <1000 mm3 o Platelets <50,000 per mm3 o Hemoglobin <10 g/dL o Aspartate aminotransferase and alanine aminotransferase >5 Ã? ULN o Creatinine >1.5 Ã? ULN <br/ >3. Patients with confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline. <br/ >4. Known active tuberculosis (TB), history of incompletely treated TB or suspected TB (with clinical features like coughing for longer than 3 weeks, hemoptysis, chest pain) or known extrapulmonary TB <br/ >5. Known case of hepatitis B, hepatitis C or HIV infection. <br/ >6. Known hypersensitivity to etanercept or any component of the formulation <br/ >7. Patients having received Remdesivir prior to screening <br/ >8. Patients receiving cytotoxic/immunosuppressant or biologic treatments (such as tumor necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry <br/ >9. Participation in any other clinical trial of an experimental treatment for COVID-19 <br/ >10. Any condition that, in the opinion of the investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the patient at unacceptably high risk from the study.

1. Require invasive mechanical ventilation <br/ >2. Presence of any of the following abnormal laboratory values at screening: o Absolute neutrophil count <1000 mm3 o Platelets <50,000 per mm3 o Hemoglobin <10 g/dL o Aspartate aminotransferase and alanine aminotransferase >5 Ã? ULN o Creatinine >1.5 Ã? ULN <br/ >3. Patients with confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline. <br/ >4. Known active tuberculosis (TB), history of incompletely treated TB or suspected TB (with clinical features like coughing for longer than 3 weeks, hemoptysis, chest pain) or known extrapulmonary TB <br/ >5. Known case of hepatitis B, hepatitis C or HIV infection. <br/ >6. Known hypersensitivity to etanercept or any component of the formulation <br/ >7. Patients having received Remdesivir prior to screening <br/ >8. Patients receiving cytotoxic/immunosuppressant or biologic treatments (such as tumor necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry <br/ >9. Participation in any other clinical trial of an experimental treatment for COVID-19 <br/ >10. Any condition that, in the opinion of the investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the patient at unacceptably high risk from the study.