Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Acute Respiratory Distress Syndrome and ARDS, sponsored by Direct Biologics.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
To evaluate the 60-day mortality rate for IMP 15mL as a treatment for moderate-to-severe ARDS compared to placebo. Reducing the mortality rate for hospitalized patients with moderate-to-severe ARDS is a measure of the treatment effect.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 970 participants |
| Start Date | 2022-07-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 3 |
What NCT05354141 shows while recruiting
NCT05354141 is an interventional study that assigns participants to a tested intervention. The registered 970 participants enrollment target is mid-sized for trials with a published cap, above the 336-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (189% higher).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Acute Respiratory Distress Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05354141's enrollment target sits among peer trials
970 4th of 31 higher than 28 of 31 other Acute Respiratory Distress Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Respiratory Distress Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome
RECRUITING · Phase 3
-
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)
RECRUITING · Phase 2
-
The ARISE Study - Use of Vertical Positioning
RECRUITING · NA
-
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort C: Bevacizumab
RECRUITING · Phase 2
-
The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
RECRUITING · NA
-
Dead Space and Inhaled Nitric Oxide in Pediatric Acute Respiratory Distress Syndrome
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06948422 · 974 participants · Phase 3
A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)
- NCT05600777 · 975 participants · Phase 3
A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
- NCT06541704 · 975 participants · Phase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
- NCT06820736 · 975 participants · NA
A Prospective, Randomized Comparison Of Drainage Techniques After One- Or Two-Level Open Posterior Lumbar Decompression Or Decompression And Fusion
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI