There is one clinical trial.
This study is designed rapidly assess safety and preliminary efficacy in hospitalized patients with COVID-19 respiratory distress to provide clinical guidance for possible wider use in treating patients in this pandemic environment. This data will be used for FDA IND filings and pursuit of a BLA.
Description: Frequency of all reported adverse events in study
Measure: Frequency of all adverse events Time: Through study completion, an average of three monthsDescription: Frequency of SAEs in the 6 hours post-infusion for each infusion
Measure: Frequency of infusion related serious adverse events Time: 6 hours post infusionDescription: Frequency of all serious adverse events in study
Measure: Frequency of serious adverse events Time: Through study completion, an average of three monthsDescription: All-cause mortality through Day 28
Measure: Mortality Time: Study days 0-28Description: Ventilator free days through Study day 28
Measure: Ventilator Free Days Time: Study days 0-28Description: Total days not in ICU from Study day 0 through Study day 28
Measure: ICU Free Days Time: Days 0 through 28Description: Total Days in Hospital from Day 0 through discharge for survivors
Measure: Total Hospital Days Time: Days 0 through discharge, an average of 28 daysDescription: Total Days in ICU from Day 0 through discharge for survivors
Measure: Total ICU Days Time: Days 0 through discharge, an average of 28 daysDescription: Improvement in oxygenation comparing Study day 0, to days 2, 4, 6
Measure: Improvement in Oxygenation Time: Study days 0, 2, 4, 6