Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS

Phase 2 Completed 102 enrolled Direct Biologics, LLC

RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start: 2020-09-24
Primary completion: 2021-05-01
Completion: 2021-05-22

Outcome

Missed primary endpoint

registry analysis (other test); Experimental Dose 2 vs Placebo; p = 0.1343; Chi-squared NCT04493242 ↗

paper compared with placebo (not significant, χ2, P = .1343). PMID 37356708 ↗

Publications

Lightner AL, Sengupta V, Qian S, Ransom JT, Suzuki S, Park DJ, Melson TI, Williams BP, Walsh JJ, Awili M. Bone Marrow Mesenchymal Stem Cell-Derived Extracellular Vesicle Infusion for the Treatment of Respiratory Failure From COVID-19: A Randomized, Placebo-Controlled Dosing Clinical Trial. Chest. 2023 Dec;164(6):1444-1453. doi: 10.1016/j.chest.2023.06.024. Epub 2023 Jun 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ExoFlo	Other / unclassified	10 ml	Intravenous
Subject	ExoFlo	Other / unclassified	15 ml	Intravenous