Official Title
Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment: Expanded Access Protocol for Patients With COVID-19 Associated ARDS Who Do Not Qualify for Phase II Randomized Control Trial
Brief Summary

Infusion Treatment Using Bone Marrow Mesenchymal Stem Cell (bmMSC) Derived Extracellular Vesicle Product, ExoFlo™, for COVID-19 Associated ARDS (EXIT COVID-19), is currently being studied in Protocol DB-EF-PhaseII-001 in patients with COVID-19 associated moderate to severe Acute Respiratory Distress Syndrome (ARDS). This expanded access protocol is an open-label study intended to provide ExoFlo to critically ill patients who do not qualify for the Phase II randomized controlled trial because they: - Do not meet phase II eligibility criteria at current phase II sites. - Do meet phase II eligibility criteria but cannot access phase II sites. - Do not meet phase II eligibility criteria & cannot access phase II sites. •

Available
Intermediate-size Population
COVID19
ARDS
Hypoxia
Cytokine Storm

Biological: Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment
Intravenous Infusion over 60 minutes
Other Name: ExoFlo

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Contacts

Heidi Moran
800-791-1021
hmoran@directbiologics.com

Direct Biologics, LLC
NCT Number
Keywords
Covid-19
ARDS
SARS-CoV-2
MeSH Terms
COVID-19
Hypoxia
Cytokine Release Syndrome