There is one clinical trial.
The purpose of the study is to determine if a high dose of IVIG plus SMT can reduce all-cause
mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to
the ICU through Day 29.
Primary Outcomes
Measure: All-Cause Mortality Rate Through Day 29 Time: Up to Day 29
Secondary Outcomes
Measure: Time to Actual ICU Discharge Time: Day 1 through Day 29
Measure: Duration of Mechanical Ventilation Time: Day 1 through Day 29
Measure: Time to Actual Hospital Discharge Time: Day 1 through Day 29
Measure: Duration of Any Oxygen Use Time: Day 1 through Day 29
Measure: Absolute Value and Mean 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: Overall Number of Participants who Develop Acute Respiratory Distress Syndrome (ARDS) Time: Up to Day 29
Measure: Number of Participants who Develop ARDS Distributed by Severity Time: Up to Day 29
Measure: Change from Baseline in Sequential Organ Failure Assessment (SOFA) Score Time: Days 5, 15, and 29
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