CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 102 enrolled
Drug / intervention
ExoFlo +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04493242
NCT04493242Phase 2Completed
CompareCT.gov

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS): A Phase II Clinical Trial

Direct Biologics, LLC·interventional·Posted Jul 30, 2020·Updated Feb 13, 2024

In Brief

A Phase 2 clinical trial evaluating ExoFlo and Intravenous normal saline for COVID-19 and ARDS. Completed, enrolled 102 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19, ARDS
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJul 30, 2020
Enrollment StartSep 24, 2020
Primary CompletionMay 1, 2021
Study CompletionMay 22, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.9 years ago

Interventions

ExoFlobiological

Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles

Intravenous normal salineother

Placebo