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New treatment option for Acute Respiratory Distress Syndrome
Official title Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)
ClinicalTrials.gov ID: NCT05354141
What this study is testing
What is ExoFlo?
ExoFlo is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute respiratory distress syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Men and women aged 18-75 years of age
- Presence of the following criteria for moderate to severe ARDS as defined by the Berlin Criteria within 24 hours of the first infustion:
- Onset within 7 days of known clinical insult or requiring increasing respiratory rate, increasing oxygen flows, or increased work of breathing, and
- Bilateral lung opacities not fully explained by pleural effusions, atelectasis, or nodules, and
- PaO2/FiO2 (P/F ratio) ≤ 200 mm Hg, and
You likely can't join if
- Lack of signed and dated informed consent form (either by the individual or by the individual's healthcare proxy).
- Stated unwillingness to comply with all study procedures and availability for the duration of the study
- Vulnerable populations such as pregnant patients, children, individuals with severe physical or mental disabilities who cannot provide meaningful...
- Active malignancy requiring treatment within the last two years, with the exception of non-melanoma skin cancers.
- Major physical trauma in the last 2 days, including motor vehicle accidents, assaults, mechanical falls with sequelae of significant bleeding or...
- Duration of mechanical ventilation exceeds 3 days or 72 hours from diagnosis of ARDS.
See the full eligibility criteria
- Men and women aged 18-75 years of age
- Presence of the following criteria for moderate to severe ARDS as defined by the Berlin Criteria within 24 hours of the first infustion:
- Onset within 7 days of known clinical insult or requiring increasing respiratory rate, increasing oxygen flows, or increased work of breathing, and
- Bilateral lung opacities not fully explained by pleural effusions, atelectasis, or nodules, and
- PaO2/FiO2 (P/F ratio) ≤ 200 mm Hg, and
- 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
- Respiratory failure not fully explained by cardiac failure or fluid overload.
- Lack of signed and dated informed consent form (either by the individual or by the individual's healthcare proxy).
- Stated unwillingness to comply with all study procedures and availability for the duration of the study
- Vulnerable populations such as pregnant patients, children, individuals with severe physical or mental disabilities who cannot provide meaningful consent.
- Active malignancy requiring treatment within the last two years, with the exception of non-melanoma skin cancers.
- 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...
- Duration of mechanical ventilation exceeds 3 days or 72 hours from diagnosis of ARDS.
- ALT or AST \> 8 x Upper Limit of Normal (ULN).
- Documented history of cirrhosis.
- DNR order, as in electing not to receive chest compressions, cardiac defibrillation, cardiac drugs, or intubation.
- Moribund-expected survival \< 24 hours.
- Severe metabolic disturbances at randomization (e.g., ketoacidosis, pH \< 7.2)
- Patient currently connected to Extracorporeal Membrane Oxygenation at initiation of screening.
- 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...
- Use of investigational COVID-19 agents or any other investigational agents within 30 days prior to the first dose.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Davis, California, United States
- Irvine, California, United States
- Sacramento, California, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Boise, Idaho, United States
- Iowa City, Iowa, United States
- Silver Spring, Maryland, United States
- Boston, Massachusetts, United States
- Burlington, Massachusetts, United States
- Springfield, Massachusetts, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- Jackson, Mississippi, United States
- Flushing, New York, United States
- Queens, New York, United States
- The Bronx, New York, United States
- Durham, North Carolina, United States
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Davis, California, United States; Irvine, California, United States; Sacramento, California, United States; Washington D.C., District of Columbia, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.