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NCT05354141 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Acute Respiratory Distress Syndrome and ARDS, sponsored by Direct Biologics.

Recruiting
Registry status
Phase 3
Development phase
970
Enrollment target
20
Study locations

NCT05354141 is a Phase 3 study of Acute Respiratory Distress Syndrome and ARDS that is actively recruiting participants, run by Direct Biologics. The registered enrollment target is 970 participants, above the 336-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (189% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT05354141, a Phase 3 study of Acute Respiratory Distress Syndrome and ARDS, is actively recruiting participants, sponsored by Direct Biologics.

RECRUITING
Registry status
Phase 3
Development phase
970 participants
Enrollment target
20
Study locations

Study 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).

Conditions Studied

Acute Respiratory Distress Syndrome ARDS

Interventions

  • BIOLOGICAL ExoFlo
  • OTHER Intravenous normal saline

Study Locations (20)

California

  • Direct Biologics Investigational Site - Davis
  • Direct Biologics Investigational Site - Irvine
  • Direct Biologics Investigational Site - Sacramento

Massachusetts

  • Direct Biologics Investigational Site - Boston
  • Direct Biologics Investigational Site - Burlington
  • Direct Biologics Investigational Site - Springfield

New York

  • Direct Biologics Investigational Site - Flushing
  • Direct Biologics Investigational Site - Queens
  • Direct Biologics Investigational Site - The Bronx

Arizona

  • Direct Biologics Investigational Site - Phoenix

Arkansas

  • Direct Biologics Investigational Site - Little Rock

District of Columbia

  • Direct Biologics Investigational Site - Washington D.C.

Florida

  • Direct Biologics Investigational Site - Jacksonville

Idaho

  • Direct Biologics Investigational Site - Boise

Trial Details

FieldValue
Enrollment Target 970 participants
Start Date 2022-07-01
Est. Completion 2027-12-31
Phase Phase 3

Sponsor

Direct Biologics

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05354141

The ClinicalTrials.gov registry entry for NCT05354141 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 970 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 336-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (189% higher). The listed sponsor is Direct Biologics, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Acute Respiratory Distress Syndrome appearing as the primary indexed condition, and to 2 interventions - of which ExoFlo is the first listed.

NCT05354141 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Massachusetts, New York.

Frequently Asked Questions

What is clinical trial NCT05354141 about?

NCT05354141 is a clinical study titled "Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)". 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).

What is the current status of trial NCT05354141?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 970 participants. The study started on 2022-07-01. Estimated completion is 2027-12-31.

What conditions does trial NCT05354141 study?

This clinical trial studies the following conditions: Acute Respiratory Distress Syndrome, ARDS.

What interventions are being tested in trial NCT05354141?

The interventions under investigation include: ExoFlo (BIOLOGICAL), Intravenous normal saline (OTHER).

Who is sponsoring clinical trial NCT05354141?

This trial is sponsored by Direct Biologics, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05354141 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.