A Global Expanded Access Protocol on Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Infusion Treatment for Patients With COVID-19 Associated ARDS

Inclusion Criteria: 1. Provision of informed consent by self or proxy. 2. Stated willingness to comply with study protocol. 3. Male or female of any age≥ 18 years of age 4. May be pregnantunless the patient has one or more conditions listed under Exclusion Criteria #4. 5. PositiveReverse Transcriptase Polymerase Chain Reaction (RT-PCR) SARS-CoV-2. 6. Moderate to severe ARDS as defined by timing within 1 week of known clinical insult or new or worsening respiratory symptoms, bilateral opacities not fully explained by effusions or lung collapse, and respiratory failure not fully explained by cardiac failure or fluid overload, and PaO2/FiO2£200 mmHg. 7. Acute presentation of hypoxic respiratory failurerequiring noninvasive oxygen support OR mechanical ventilation (MV). 8. Agreementto use highly effective birth control contraceptionif of reproductive age and potential.

Exclusion Criteria: 1. Active malignancy requiring treatment within the last five years. 2. Eligibility for enrollment in Protocol DB-EF-PhaseII-001. 3. Patients who are not full code. 4. Pregnant patients with current or past history of eclampsia, preeclampsia, hemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome during pregnancy. 5. New York Heart Association (NYHA)Functional Class III (symptoms present during ordinary activities) or IV Heart Failure (symptoms present at rest)or listed for heart transplant. 6. Chronic Kidney Disease (CKD) Stage IV (GFR 15-29 mL/min/1.73m2)and Stage V (GFR