There is one clinical trial.
The primary objective of the study is to determine if Prolastin plus SMT can reduce the
proportion of participants dying or requiring intensive care unit (ICU) admission on or
before Day 15 or who are dependent on invasive mechanical ventilation on Day 15 versus SMT
alone in hospitalized participants with Coronavirus disease 2019 (COVID-19).
Primary Outcomes
Measure: Percentage of Participants Dying or Requiring ICU Admission Time: Up to Day 15
Measure: Percentage of Participants Who are Dependent on Invasive Mechanical Ventilation Time: Day 15
Secondary Outcomes
Measure: Change from Baseline in National Early Warning Score (NEWS) Time: Day 1 through Day 29
Measure: Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours Time: Day 1 through Day 29
Measure: Time to Hospital Discharge Time: Day 1 through Day 29
Measure: Duration of ICU Stay Time: Up to Day 29
Measure: Duration of Any Oxygen Use Time: Day 1 through Day 29
Measure: Duration of Mechanical Ventilation Time: Up to Day 29
Measure: Mean Change from Baseline in Ordinal Scale Time: Day 1 through Day 29
Measure: Absolute Value Change from Baseline in Ordinal Scale Time: Day 1 through Day 29
Measure: Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale Time: Day 15, Day 29
Measure: Time to Sustained Normalization of Temperature Time: Day 1 through Day 29
Measure: Percentage of Participants who Sustained Normalization of Temperature Time: Day 1 through Day 29
Measure: Number of Participants who Develop Acute Respiratory Distress Syndrome (ARDS) Time: Up to Day 29
Measure: Length of Time to Clinical Progression Time: Up to Day 29
Measure: Mortality Through Day 29 Time: Up to Day 29