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

Inclusion Criteria:

1. Men and women aged 18-75 years of age

2. Presence of the following criteria for moderate to severe ARDS as defined by theBerlin Criteria within 24 hours of the first infustion:

3. Onset within 7 days of known clinical insult or requiring increasingrespiratory rate, increasing oxygen flows, or increased work of breathing, and

4. Bilateral lung opacities not fully explained by pleural effusions, atelectasis,or nodules, and

5. PaO2/FiO2 (P/F ratio) ≤ 200 mm Hg, and

6. Invasive or noninvasive ventilation with a minimum PEEP 5 cm H2O or minimum ofcontinuous positive airway pressure (CPAP) 5 cm H2O, or High Flow Nasal Oxygenat ≥ 30 L/min, and

7. Respiratory failure not fully explained by cardiac failure or fluid overload.

Exclusion Criteria:

1. Lack of signed and dated informed consent form (either by the individual or by theindividual's healthcare proxy).

2. Stated unwillingness to comply with all study procedures and availability for theduration of the study

3. Vulnerable populations such as pregnant patients, children, individuals with severephysical or mental disabilities who cannot provide meaningful consent.

4. Active malignancy requiring treatment within the last two years, with the exceptionof 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 craniofacialbruising, and surgeries, such that not one or more injury may be undiagnosed at timeof screening.

6. Duration of mechanical ventilation exceeds 3 days or 72 hours from diagnosis ofARDS.

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 ofscreening.

13. If the candidate, either a male or female of reproductive potential, is unwilling totwo methods of highly effective birth control contraception such as condoms withoral contraceptive pill or choose to remain abstinent if already practicingabstinence during the screening period. The required duration of usage of doublemethod OR maintenance of abstinence must include the time from the beginning of thescreening period until Day 61, day of withdrawal or early termination

14. Use of investigational COVID-19 agents or any other investigational agents within 30days prior to the first dose.