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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Direct Biologics, LLC
Study ID
NCT05354141
Phase
PHASE3
Status
Recruiting
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Conditions

  • ARDS
  • Acute Respiratory Distress Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ExoFlo — BIOLOGICAL
    Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles
  • Intravenous normal saline — OTHER
    Placebo

Study Details

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).

Key Dates

Start date
Jul 1, 2022
Status verified
Feb 2026
Primary completion
Nov 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
970 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Normal saline 100 mL
  • Experimental: Experimental Dose
    Normal saline 85 mL and ExoFlo 15 mL

Primary Outcome Measure

Evaluation of 60-day All-cause Mortality [ Time Frame: 60 days ]

Central Contacts

Locations (32)

FacilityCityStateZIPSite coordinators
Direct Biologics Investigational SitePhoenixArizona85012-
Direct Biologics Investigational SiteLittle RockArkansas72205-
Direct Biologics Investigational SiteDavisCalifornia95817-
Direct Biologics Investigational SiteIrvineCalifornia92627-
Direct Biologics Investigational SiteSacramentoCalifornia95817-
Direct Biologics Investigational SiteWashington D.C.District of Columbia20010-
Direct Biologics Investigational SiteJacksonvilleFlorida32224-
Direct Biologics Investigational SiteBoiseIdaho83712-
Direct Biologics Investigational SiteIowa CityIowa52242-
Direct Biologics Investigational SiteSilver SpringMaryland20910-
Direct Biologics Investigational SiteBostonMassachusetts02115-
Direct Biologics Investigational SiteBurlingtonMassachusetts01805-
Direct Biologics Investigational SiteSpringfieldMassachusetts01199-
Direct Biologics Investigational SiteDetroitMichigan48202-
Direct Biologics Investigational SiteRochesterMinnesota55905-
Direct Biologics Investigational SiteJacksonMississippi39202-
Direct Biologics Investigational SiteFlushingNew York11368-
Direct Biologics Investigational SiteQueensNew York11040-
Direct Biologics Investigational SiteThe BronxNew York10467-
Direct Biologics Investigational SiteDurhamNorth Carolina27710-
Direct Biologics Investigational SiteWinston-SalemNorth Carolina27157-
Direct Biologics Investigational SiteCincinnatiOhio45219-
Direct Biologics Investigational SiteClevelandOhio44106-
Direct Biologics Investigational SitePortlandOregon97239-
Direct Biologics Investigational SiteCharlestonSouth Carolina29425-
Direct Biologics Investigational SiteKnoxvilleTennessee37996-
Direct Biologics Investigational SiteNashvilleTennessee37235-
Direct Biologics Investigational SiteDallasTexas75246-
Direct Biologics Investigational SiteFort WorthTexas76104-
Direct Biologics Investigational SiteHoustonTexas77030-
Direct Biologics Investigational SiteMurrayUtah84107-
Direct Biologics Investigational SiteSalt Lake CityUtah84101-

Find similar trials in Phoenix, AZ

By research site
Direct Biologics Investigational Site· Phoenix, AZDirect Biologics Investigational Site· Little Rock, ARDirect Biologics Investigational Site· Davis, CADirect Biologics Investigational Site· Irvine, CADirect Biologics Investigational Site· Sacramento, CADirect Biologics Investigational Site· Washington D.C., DC

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