drugset / Trial / NCT05354141

Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)

NCT05354141 ↗

Phase 3 Recruiting 970 enrolled Direct Biologics, LLC
RandomizedParallel-groupTriple-blindTreatment

Summary

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).

Timeline

Start
2022-07-01
Primary completion
2027-11-30
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject ExoFlo Other / unclassified 15 ml Intravenous