To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EVs), ExoFlo, versus placebo for the treatment of hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).
This is a Phase III, multicenter, randomized, double-blinded, placebo-controlled trial for the treatment of moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
970
Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles
Placebo
Evaluation of 60-day All-cause Mortality
To evaluate the 60-day mortality rate for IMP 15mL as a treatment for moderate-to-severe ARDS compared to placebo. Reducing the mortality rate for hospitalized patients with moderate-to-severe ARDS is a measure of the treatment effect.
Time frame: 60 days
Time to death
Reducing the mortality rate for hospitalized patients moderate-to-severe ARDS is a measure of the treatment effect.
Time frame: 60 days
Ventilator-free days (VFDs)
Number of days for which patients are not on mechanical ventilation.
Time frame: Day 29
Oxygen free days
Number of days for which patients are not on oxygen support.
Time frame: Day 29
ICU free days
Number of days for which patients are not in the ICU.
Time frame: Day 29
Incidence of Treatment Emergent Serious Adverse Events (TESAEs)
Safety comparison performed between IMP 15 mL and placebo arms
Time frame: 61 days
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