To evaluate the safety and efficacy of intravenous administration of bone marrow derived extracellular vesicles, ExoFlo, versus placebo as treatment for moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) in patients with severe COVID-19.
This is a Phase II, double-blinded, placebo-controlled, randomized controlled trial that enrolled 102 subjects that were admitted with COVID-19 associated moderate-to-severe ARDS across 6 sites in the United States.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
102
Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles
Placebo
Direct Biologics Investigational Site
Sheffield, Alabama, United States
Direct Biologics Investigational Site
Anaheim, California, United States
Direct Biologics Investigational Site
Sayre, Pennsylvania, United States
Direct Biologics Investigational Site
Houston, Texas, United States
Evaluation of 60-day Mortality Rate
To evaluate the 60-day mortality rate for IP 15mL as a treatment for COVID-19 associated moderate to severe ARDS compared to placebo. Reducing the mortality rate for hospitalized patients with COVID-19 associated ARDS is a measure of the treatment effect.
Time frame: 60 days
Overall Survival Rates
Reducing the mortality rate for hospitalized patients with COVID-19 associated ARDS is a measure of the treatment effect.
Time frame: Days 15, 30, 60
Proportion of Discharged Patients
Discharge is an unbiased measure of overall clinical improvement.
Time frame: Days 7, 30, 60
Time to Discharge
Discharge is an unbiased measure of overall clinical improvement.
Time frame: Number of days from the date of randomization until documented discharge from hospital, up to 60 days.
Incidence of Treatment Emergent Serious Adverse Events
Safety comparison performed between IP 15 mL and placebo arms
Time frame: 61 days
Ventilation Free Days
Number of days for which patients are not on mechanical ventilation.
Time frame: Within 60 days of follow-up
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Direct Biologics Investigational Site
Lubbock, Texas, United States
Direct Biologics Investigational Site
Mesquite, Texas, United States