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

1. anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. 2. subject meets criteria for ordinal scale category 6 or 7 at the time of screening. 3. subject has a positive test for influenza virus during this current hospital admission. 4. subjects with an estimated glomerular filtration rate (egfr) \< 30 ml/min are excluded unless in the opinion of the pi, the potential benefit of receiving remdesivir outweighs the potential risk of study participation. 5. alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 5 times the upper limits of normal. 6. total white cell blood cell count (wbc) \<1500 cells/microliter. 7. platelet count \<50,000/microliter. 8. history of chronic liver disease (e.g., jaundice, ascites, hepatic encephalopathy, history of bleeding esophageal or gastric varices). no laboratory testing is needed. 9. pregnancy or breast feeding (lactating women who agree to discard breast milk from day 1 until three weeks after the last study product is given are not excluded). 10. allergy to any study medication including history of hypersensitivity to natural or recombinant interferon beta or human albumin. 11. patient has a chronic or acute medical condition or is taking a medication that cannot be discontinued at enrollment, that in the judgement of the pi, places them at unacceptable risk for a poor clinical outcome if they were to participate in the study. 12. received three or more doses of remdesivir, including the loading dose, outside of the study for covid-19. 13. received convalescent plasma or intravenous immunoglobulin \[ivig\] for the treatment of covid-19. 14. received any interferon product within two weeks of screening, either for the treatment of covid-19 or for a chronic medical condition (e.g., multiple sclerosis, hcv infection). 15. received any of the following in the two weeks prior to screening as treatment of covid-19: * small molecule tyrosine kinase inhibitors (e.g. baricitinib, imatinib, gefitinib, acalabrutinib, etc.); * monoclonal antibodies targeting cytokines (e.g., tnf inhibitors, anti-interleukin-1 \[il-1\], anti-il-6 \[tocilizumab or sarilumab\], etc.); * monoclonal antibodies targeting t-cells or b-cells as treatment for covid-19. 16. prior enrollment in actt-3.

1. anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. 2. subject meets criteria for ordinal scale category 6 or 7 at the time of screening. 3. subject has a positive test for influenza virus during this current hospital admission. 4. subjects with an estimated glomerular filtration rate (egfr) \< 30 ml/min are excluded unless in the opinion of the pi, the potential benefit of receiving remdesivir outweighs the potential risk of study participation. 5. alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 5 times the upper limits of normal. 6. total white cell blood cell count (wbc) \<1500 cells/microliter. 7. platelet count \<50,000/microliter. 8. history of chronic liver disease (e.g., jaundice, ascites, hepatic encephalopathy, history of bleeding esophageal or gastric varices). no laboratory testing is needed. 9. pregnancy or breast feeding (lactating women who agree to discard breast milk from day 1 until three weeks after the last study product is given are not excluded). 10. allergy to any study medication including history of hypersensitivity to natural or recombinant interferon beta or human albumin. 11. patient has a chronic or acute medical condition or is taking a medication that cannot be discontinued at enrollment, that in the judgement of the pi, places them at unacceptable risk for a poor clinical outcome if they were to participate in the study. 12. received three or more doses of remdesivir, including the loading dose, outside of the study for covid-19. 13. received convalescent plasma or intravenous immunoglobulin \[ivig\] for the treatment of covid-19. 14. received any interferon product within two weeks of screening, either for the treatment of covid-19 or for a chronic medical condition (e.g., multiple sclerosis, hcv infection). 15. received any of the following in the two weeks prior to screening as treatment of covid-19: * small molecule tyrosine kinase inhibitors (e.g. baricitinib, imatinib, gefitinib, acalabrutinib, etc.); * monoclonal antibodies targeting cytokines (e.g., tnf inhibitors, anti-interleukin-1 \[il-1\], anti-il-6 \[tocilizumab or sarilumab\], etc.); * monoclonal antibodies targeting t-cells or b-cells as treatment for covid-19. 16. prior enrollment in actt-3.

Nov. 16, 2021, 6:30 p.m. usa

anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. subject meets criteria for ordinal scale category 6 or 7 at the time of screening. subject has a positive test for influenza virus during this current hospital admission. subjects with an estimated glomerular filtration rate (egfr) < 30 ml/min are excluded unless in the opinion of the pi, the potential benefit of receiving remdesivir outweighs the potential risk of study participation. alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 5 times the upper limits of normal. total white cell blood cell count (wbc) <1500 cells/microliter. platelet count <50,000/microliter. history of chronic liver disease (e.g., jaundice, ascites, hepatic encephalopathy, history of bleeding esophageal or gastric varices). no laboratory testing is needed. pregnancy or breast feeding (lactating women who agree to discard breast milk from day 1 until three weeks after the last study product is given are not excluded). allergy to any study medication including history of hypersensitivity to natural or recombinant interferon beta or human albumin. patient has a chronic or acute medical condition or is taking a medication that cannot be discontinued at enrollment, that in the judgement of the pi, places them at unacceptable risk for a poor clinical outcome if they were to participate in the study. received three or more doses of remdesivir, including the loading dose, outside of the study for covid-19. received convalescent plasma or intravenous immunoglobulin [ivig] for the treatment of covid-19. received any interferon product within two weeks of screening, either for the treatment of covid-19 or for a chronic medical condition (e.g., multiple sclerosis, hcv infection). received any of the following in the two weeks prior to screening as treatment of covid-19: small molecule tyrosine kinase inhibitors (e.g. baricitinib, imatinib, gefitinib, acalabrutinib, etc.); monoclonal antibodies targeting cytokines (e.g., tnf inhibitors, anti-interleukin-1 [il-1], anti-il-6 [tocilizumab or sarilumab], etc.); monoclonal antibodies targeting t-cells or b-cells as treatment for covid-19. prior enrollment in actt-3.

anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. subject meets criteria for ordinal scale category 6 or 7 at the time of screening. subject has a positive test for influenza virus during this current hospital admission. subjects with an estimated glomerular filtration rate (egfr) < 30 ml/min are excluded unless in the opinion of the pi, the potential benefit of receiving remdesivir outweighs the potential risk of study participation. alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 5 times the upper limits of normal. total white cell blood cell count (wbc) <1500 cells/microliter. platelet count <50,000/microliter. history of chronic liver disease (e.g., jaundice, ascites, hepatic encephalopathy, history of bleeding esophageal or gastric varices). no laboratory testing is needed. pregnancy or breast feeding (lactating women who agree to discard breast milk from day 1 until three weeks after the last study product is given are not excluded). allergy to any study medication including history of hypersensitivity to natural or recombinant interferon beta or human albumin. patient has a chronic or acute medical condition or is taking a medication that cannot be discontinued at enrollment, that in the judgement of the pi, places them at unacceptable risk for a poor clinical outcome if they were to participate in the study. received three or more doses of remdesivir, including the loading dose, outside of the study for covid-19. received convalescent plasma or intravenous immunoglobulin [ivig] for the treatment of covid-19. received any interferon product within two weeks of screening, either for the treatment of covid-19 or for a chronic medical condition (e.g., multiple sclerosis, hcv infection). received any of the following in the two weeks prior to screening as treatment of covid-19: small molecule tyrosine kinase inhibitors (e.g. baricitinib, imatinib, gefitinib, acalabrutinib, etc.); monoclonal antibodies targeting cytokines (e.g., tnf inhibitors, anti-interleukin-1 [il-1], anti-il-6 [tocilizumab or sarilumab], etc.); monoclonal antibodies targeting t-cells or b-cells as treatment for covid-19. prior enrollment in actt-3.

Nov. 14, 2020, 11:31 p.m. usa

1. anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. 2. subject meets criteria for ordinal scale category 6 or 7 at the time of screening. 3. subject has a positive test for influenza virus during this current hospital admission. 4. subjects with an estimated glomerular filtration rate (egfr) < 30 ml/min are excluded unless in the opinion of the pi, the potential benefit of receiving remdesivir outweighs the potential risk of study participation. 5. alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 5 times the upper limits of normal. 6. total white cell blood cell count (wbc) <1500 cells/microliter. 7. platelet count <50,000/microliter. 8. history of chronic liver disease (e.g., jaundice, ascites, hepatic encephalopathy, history of bleeding esophageal or gastric varices). no laboratory testing is needed. 9. pregnancy or breast feeding (lactating women who agree to discard breast milk from day 1 until three weeks after the last study product is given are not excluded). 10. allergy to any study medication including history of hypersensitivity to natural or recombinant interferon beta or human albumin. 11. patient has a chronic or acute medical condition or is taking a medication that cannot be discontinued at enrollment, that in the judgement of the pi, places them at unacceptable risk for a poor clinical outcome if they were to participate in the study. 12. received three or more doses of remdesivir, including the loading dose, outside of the study for covid-19. 13. received convalescent plasma or intravenous immunoglobulin [ivig] for the treatment of covid-19. 14. received any interferon product within two weeks of screening, either for the treatment of covid-19 or for a chronic medical condition (e.g., multiple sclerosis, hcv infection). 15. received any of the following in the two weeks prior to screening as treatment of covid-19: - small molecule tyrosine kinase inhibitors (e.g. baricitinib, imatinib, gefitinib, acalabrutinib, etc.); - monoclonal antibodies targeting cytokines (e.g., tnf inhibitors, anti-interleukin-1 [il-1], anti-il-6 [tocilizumab or sarilumab], etc.); - monoclonal antibodies targeting t-cells or b-cells as treatment for covid-19. 16. prior enrollment in actt-3.

1. anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. 2. subject meets criteria for ordinal scale category 6 or 7 at the time of screening. 3. subject has a positive test for influenza virus during this current hospital admission. 4. subjects with an estimated glomerular filtration rate (egfr) < 30 ml/min are excluded unless in the opinion of the pi, the potential benefit of receiving remdesivir outweighs the potential risk of study participation. 5. alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 5 times the upper limits of normal. 6. total white cell blood cell count (wbc) <1500 cells/microliter. 7. platelet count <50,000/microliter. 8. history of chronic liver disease (e.g., jaundice, ascites, hepatic encephalopathy, history of bleeding esophageal or gastric varices). no laboratory testing is needed. 9. pregnancy or breast feeding (lactating women who agree to discard breast milk from day 1 until three weeks after the last study product is given are not excluded). 10. allergy to any study medication including history of hypersensitivity to natural or recombinant interferon beta or human albumin. 11. patient has a chronic or acute medical condition or is taking a medication that cannot be discontinued at enrollment, that in the judgement of the pi, places them at unacceptable risk for a poor clinical outcome if they were to participate in the study. 12. received three or more doses of remdesivir, including the loading dose, outside of the study for covid-19. 13. received convalescent plasma or intravenous immunoglobulin [ivig] for the treatment of covid-19. 14. received any interferon product within two weeks of screening, either for the treatment of covid-19 or for a chronic medical condition (e.g., multiple sclerosis, hcv infection). 15. received any of the following in the two weeks prior to screening as treatment of covid-19: - small molecule tyrosine kinase inhibitors (e.g. baricitinib, imatinib, gefitinib, acalabrutinib, etc.); - monoclonal antibodies targeting cytokines (e.g., tnf inhibitors, anti-interleukin-1 [il-1], anti-il-6 [tocilizumab or sarilumab], etc.); - monoclonal antibodies targeting t-cells or b-cells as treatment for covid-19. 16. prior enrollment in actt-3.

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

1. anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. 2. subject is on or being prepared to go on extracorporeal membrane oxygenation (ecmo) at the time of screening. 3. subjects with an estimated glomerular filtration rate (egfr) < 30 ml/min are excluded unless in the opinion of the pi, the potential benefit of receiving remdesivir outweighs the potential risk of study participation. 4. alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 5 times the upper limits of normal. 5. total white cell blood cell count (wbc) <1500 cells/microliter. 6. platelet count <50,000/microliter. 7. history of chronic liver disease (e.g., jaundice, ascites, hepatic encephalopathy, history of bleeding esophageal or gastric varices). no laboratory testing is needed. 8. pregnancy or breast feeding (lactating women who agree to discard breast milk from day 1 until two weeks after the last study product is given are not excluded). 9. allergy to any study medication including history of hypersensitivity to natural or recombinant interferon beta or human albumin. 10. patient has a chronic or acute medical condition or is taking a medication that cannot be discontinued at enrollment, that in the judgement of the pi, places them at unacceptable risk for a poor clinical outcome if they were to participate in the study. 11. received three or more doses of remdesivir, including the loading dose, outside of the study for covid-19. 12. received convalescent plasma or intravenous immunoglobulin [ivig] for the treatment of covid-19. 13. received any interferon product within two weeks of screening, either for the treatment of covid-19 or for a chronic medical condition (e.g., multiple sclerosis, hcv infection). 14. received any of the following in the two weeks prior to screening as treatment of covid-19: - small molecule tyrosine kinase inhibitors (e.g. baricitinib, imatinib, gefitinib, acalabrutinib, etc.); - monoclonal antibodies targeting cytokines (e.g., tnf inhibitors, anti-interleukin-1 [il-1], anti-il-6 [tocilizumab or sarilumab], etc.); - monoclonal antibodies targeting t-cells or b-cells as treatment for covid-19.

1. anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. 2. subject is on or being prepared to go on extracorporeal membrane oxygenation (ecmo) at the time of screening. 3. subjects with an estimated glomerular filtration rate (egfr) < 30 ml/min are excluded unless in the opinion of the pi, the potential benefit of receiving remdesivir outweighs the potential risk of study participation. 4. alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 5 times the upper limits of normal. 5. total white cell blood cell count (wbc) <1500 cells/microliter. 6. platelet count <50,000/microliter. 7. history of chronic liver disease (e.g., jaundice, ascites, hepatic encephalopathy, history of bleeding esophageal or gastric varices). no laboratory testing is needed. 8. pregnancy or breast feeding (lactating women who agree to discard breast milk from day 1 until two weeks after the last study product is given are not excluded). 9. allergy to any study medication including history of hypersensitivity to natural or recombinant interferon beta or human albumin. 10. patient has a chronic or acute medical condition or is taking a medication that cannot be discontinued at enrollment, that in the judgement of the pi, places them at unacceptable risk for a poor clinical outcome if they were to participate in the study. 11. received three or more doses of remdesivir, including the loading dose, outside of the study for covid-19. 12. received convalescent plasma or intravenous immunoglobulin [ivig] for the treatment of covid-19. 13. received any interferon product within two weeks of screening, either for the treatment of covid-19 or for a chronic medical condition (e.g., multiple sclerosis, hcv infection). 14. received any of the following in the two weeks prior to screening as treatment of covid-19: - small molecule tyrosine kinase inhibitors (e.g. baricitinib, imatinib, gefitinib, acalabrutinib, etc.); - monoclonal antibodies targeting cytokines (e.g., tnf inhibitors, anti-interleukin-1 [il-1], anti-il-6 [tocilizumab or sarilumab], etc.); - monoclonal antibodies targeting t-cells or b-cells as treatment for covid-19.