|
Primary Outcome Measures:1. Percentage of subjects reporting each severity rating on an 8-point ordinal scale The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. [Time Frame: Day 15] Time to recovery Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities. [Time Frame: Day 1 through Day 29] Secondary Outcome Measures:2. Change from baseline in alanine transaminase (ALT) Day 1 through Day 29 Change from baseline in alanine transaminase (ALT) Day 1 through Day 29 3. Change from baseline in aspartate transaminase (AST) Day 1 through Day 29 Change from baseline in aspartate transaminase (AST) Day 1 through Day 29 4. Change from baseline in creatinine Day 1 through Day 29 Change from baseline in creatinine Day 1 through Day 29 5. Change from baseline in glucose Day 1 through Day 29 Change from baseline in glucose Day 1 through Day 29 6. Change from baseline in hemoglobin Day 1 through Day 29 Change from baseline in hemoglobin Day 1 through Day 29 7. Change from baseline in platelets Day 1 through Day 29 Change from baseline in platelets Day 1 through Day 29 8. Change from baseline in prothrombin time (PT) Day 1 through Day 29 Change from baseline in prothrombin time (PT) Day 1 through Day 29 9. Change from baseline in total bilirubin Day 1 through Day 29 Change from baseline in total bilirubin Day 1 through Day 29 10. Change from baseline in white blood cell count with differential Day 1 through Day 29 Change from baseline in white blood cell count (WBC) with differential Day 1 through Day 29 11. Change in National Early Warning Score (NEWS) from baseline The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. [Time Frame: Day 1 through Day 29] Change in National Early Warning Score (NEWS) from baseline The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. [Time Frame: Day 1 through Day 29] 12. Clinical status using ordinal scale The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. [Time Frame: Day 3 through Day 29] Clinical status using ordinal scale The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. [Time Frame: Day 3 through Day 29] 13. Cumulative incidence of Grade 3 and 4 adverse events (AEs) Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening. [Time Frame: Day 1 through Day 29] Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs) Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening. [Time Frame: Day 1 through Day 29] 14. Cumulative incidence of serious adverse events (SAEs) An SAE is defined as an AE or suspected adverse reaction is considered serious is, in the view of either the investigator or the sponsor, if results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. [Time Frame: Day 1 through Day 29] Cumulative incidence of serious adverse events (SAEs) An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. [Time Frame: Day 1 through Day 29] 15. Discontinuation or temporary suspension of infusions For any reason. [Time Frame: Day 1 through Day 29] Discontinuation or temporary suspension of investigational therapeutics For any reason. [Time Frame: Day 1 through Day 10] 16. Duration of hospitalization Measured in days. [Time Frame: Day 1 through Day 29] Duration of hospitalization Measured in days. [Time Frame: Day 1 through Day 29] 17. Duration of new non-invasive ventilation or high flow oxygen use [Time Frame: Day 1 through Day 29] Duration of new non-invasive ventilation or high flow oxygen use Measured in days. [Time Frame: Day 1 through Day 29] 18. Duration of new oxygen use [Time Frame: Day 1 through Day 29] Duration of new oxygen use Measured in days. [Time Frame: Day 1 through Day 29] 19. Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [Time Frame: Day 1 through Day 29] Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use Measured in days. [Time Frame: Day 1 through Day 29] 20. Incidence of new non-invasive ventilation or high flow oxygen use Day 1 through Day 29 Incidence of new non-invasive ventilation or high flow oxygen use Day 1 through Day 29 21. Incidence of new oxygen use Day 1 through Day 29 Incidence of new oxygen use Day 1 through Day 29 22. Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use Day 1 through Day 29 Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use Day 1 through Day 29 23. Mean change in the ordinal scale The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. [Time Frame: Day 1 through Day 29] Mean change in the ordinal scale The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. [Time Frame: Day 1 through Day 29] 24. Number of non-invasive ventilation/high flow oxygen free days Day 1 to Day 29 25. Number of oxygenation free days [Time Frame: Day 1 to Day 29] Percentage of subjects reporting each severity rating on an 8-point ordinal scale The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. [Time Frame: Day 15] 26. Subject 14-day mortality Date and cause of death (if applicable). [Time Frame: Day 1 through Day 15] Subject 14-day mortality Date and cause of death (if applicable). [Time Frame: Day 1 through Day 15] 27. Subject 28-day mortality Date and cause of death (if applicable). [Time Frame: Day 1 through Day 29] Subject 29-day mortality Date and cause of death (if applicable). [Time Frame: Day 1 through Day 29] 28. Time to an improvement of one category using an ordinal scale The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. [Time Frame: Day 1 through Day 29] Time to an improvement of one category using an ordinal scale The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. [Time Frame: Day 1 through Day 29] 29. Time to an improvement of two categories using an ordinal scale The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. [Time Frame: Day 1 through Day 29] Time to an improvement of two categories using an ordinal scale The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. [Time Frame: Day 1 through Day 29] 30. Time to discharge or to a National Early Warning Score (NEWS) of The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. [Time Frame: Day 1 through Day 29] Time to discharge or to a National Early Warning Score (NEWS) of The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. [Time Frame: Day 1 through Day 29] 31. Ventilator/extracorporeal membrane oxygenation (ECMO) free days Day 1 through Day 29 |
|
|
