This is a Phase 2, randomized controlled, multicenter study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care (SOC) treatments for COVID-19 infection in hospitalized subjects with ARD/ARDS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Fresno Community Hospital
Fresno, California, United States
Mortality at Day 28
All-cause mortality at Day 28
Time frame: Randomization through Day 28
Mortality at Days 60 and 90
All-cause mortality at Days 60 and 90
Time frame: Randomization through Day 60 and Day 90
Number of ventilator-free days
Number of ventilator-free days through Day 28
Time frame: Randomization through Day 28
Improvement in oxygenation
Improvement in oxygenation at Day 2, 4, 6, 14, and 28 compared to Baseline, as assessed by PaO2/FiO2
Time frame: Randomization to Day 2, Day 4, Day 6, Day 14, Day 28
SOFA score at Day 28
SOFA score at Day 28 compared to Baseline
Time frame: Randomization to Day 28
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