Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)
NCT ID: NCT05354141
Last Updated: 2024-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
970 participants
INTERVENTIONAL
2022-07-01
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Normal saline 100 mL
Intravenous normal saline
Placebo
Experimental Dose
Normal saline 85 mL and ExoFlo 15 mL
ExoFlo
Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles
Interventions
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ExoFlo
Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles
Intravenous normal saline
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Presence of the following criteria for moderate to severe ARDS as defined by the Berlin Criteria within 24 hours of the first infustion:
1. Onset within 7 days of known clinical insult or requiring increasing respiratory rate, increasing oxygen flows, or increased work of breathing, and
2. Bilateral lung opacities not fully explained by pleural effusions, atelectasis, or nodules, and
3. PaO2/FiO2 (P/F ratio) ≤ 200 mm Hg, and
4. Invasive or noninvasive ventilation with a minimum PEEP 5 cm H2O or minimum of continuous positive airway pressure (CPAP) 5 cm H2O, or High Flow Nasal Oxygen at ≥ 30 L/min, and
5. Respiratory failure not fully explained by cardiac failure or fluid overload.
Exclusion Criteria
2. Stated unwillingness to comply with all study procedures and availability for the duration of the study
3. Vulnerable populations such as pregnant patients, children, individuals with severe physical or mental disabilities who cannot provide meaningful consent.
4. Active malignancy requiring treatment within the last two years, with the exception of non-melanoma skin cancers.
5. Major physical trauma in the last 2 days, including motor vehicle accidents, assaults, mechanical falls with sequelae of significant bleeding or craniofacial bruising, and surgeries, such that not one or more injury may be undiagnosed at time of screening.
6. Duration of mechanical ventilation exceeds 3 days or 72 hours from diagnosis of ARDS.
7. ALT or AST \> 8 x Upper Limit of Normal (ULN).
8. Documented history of cirrhosis.
9. DNR order, as in electing not to receive chest compressions, cardiac defibrillation, cardiac drugs, or intubation.
10. Moribund-expected survival \< 24 hours.
11. Severe metabolic disturbances at randomization (e.g., ketoacidosis, pH \< 7.2)
12. Patient currently connected to Extracorporeal Membrane Oxygenation at initiation of screening.
13. If the candidate, either a male or female of reproductive potential, is unwilling to two methods of highly effective birth control contraception such as condoms with oral contraceptive pill or choose to remain abstinent if already practicing abstinence during the screening period. The required duration of usage of double method OR maintenance of abstinence must include the time from the beginning of the screening period until Day 61, day of withdrawal or early termination
14. Use of investigational COVID-19 agents or any other investigational agents within 30 days prior to the first dose.
18 Years
75 Years
ALL
No
Sponsors
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Direct Biologics, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Bill Arana
Role: STUDY_DIRECTOR
Direct Biologics, LLC
Locations
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Direct Biologics Investigational Site
Birmingham, Alabama, United States
Direct Biologics Investigational Site
Chandler, Arizona, United States
Direct Biologics Investigational Site
Phoenix, Arizona, United States
Direct Biologics Investigational Site
Little Rock, Arkansas, United States
Direct Biologics Investigational Site
Davis, California, United States
Direct Biologics Investigational Site
Fullerton, California, United States
Direct Biologics Investigational Site
Irvine, California, United States
Direct Biologics Investigational Site
Orange, California, United States
Direct Biologics Investigational Site
Sacramento, California, United States
Direct Biologics Investigational Site
San Francisco, California, United States
Direct Biologics Investigational Site
Washington D.C., District of Columbia, United States
Direct Biologics Investigational Site
Jacksonville, Florida, United States
Direct Biologics Investigational Site
Boise, Idaho, United States
Direct Biologics Investigational Site
Iowa City, Iowa, United States
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Wichita, Kansas, United States
Direct Biologics Investigational Site
Silver Spring, Maryland, United States
Direct Biologics Investigational Site
Boston, Massachusetts, United States
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Burlington, Massachusetts, United States
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Springfield, Massachusetts, United States
Direct Biologics Investigational Site
Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Jackson, Mississippi, United States
Direct Biologics Investigational Site
Flushing, New York, United States
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Queens, New York, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
Direct Biologics Investigational Site
Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
Direct Biologics Investigational Site
Cleveland, Ohio, United States
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Portland, Oregon, United States
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Charleston, South Carolina, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Murray, Utah, United States
Direct Biologics Investigational Site
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Related Links
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Direct Biologics, LLC
Other Identifiers
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DB-EF-PHASEIII-0001
Identifier Type: -
Identifier Source: org_study_id
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