drugset / Trial / NCT05125562

Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19

NCT05125562 ↗

Phase 2 Withdrawn Direct Biologics, LLC
RandomizedParallel-groupTriple-blindTreatment

Summary

Early Mild Outpatient infusion Therapy with ExoFloTM for COVID-19 (EMOTE COVID-19) To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles, ExoFlo, as treatment for mild-moderate COVID-19.

Timeline

Start
2022-12-07
Primary completion
2023-03-07
Completion
2023-03-07

Outcome

Outcome not reported

Stopped: “Sponsor has withdrawn/closed the IND with the FDA. A letter dated 21NOV2022 was submitted to the FDA.”

Drugs

EvaluationDrugModalityDoseRoute
Subject ExoFlo Other / unclassified 10 ml Intravenous
Subject ExoFlo Other / unclassified 15 ml Intravenous

Indications