ACT-20 in Patients With Severe COVID-19 Pneumonia

Inclusion Criteria: 1. Male or female patients age 18 to 85, inclusive 2. Confirmed positive test for COVID-19 by standard reverse transcriptase polymerase chain reaction (RT-PCR) assay or equivalent 3. On mechanical ventilation (n=35), or high-flow O2 support (n=35) and: 1. Disease severity level of "moderate" (PaO2/FiO2 of 100-200) (n=35), or "severe" (PaO2/FiO2 \< 100) (n=35) as established using the Berlin Criteria for ARDS (Barbas, Isola \& Caser, 2014; Baron \& Levy, 2016). 2. Positive end-expiratory airway pressure (PEEP) ≥ 5 cmH2O 3. Oxygen saturation ≤ 93% 4. Non-cardiogenic bilateral pulmonary edema on frontal chest radiograph that cannot be explained by effusion, collapsed lung or lung nodule 5. Able to understand and provide voluntary informed consent Exclusion Criteria: 1. Unable to understand and provide voluntary informed consent 2. Current infection with HIV-1, HIV-2, Hepatitis B, Hepatitis C or HTLV 3. History of malignancy, other than non-melanoma skin cancer or non-metastatic prostate cancer 4. Currently receiving extracorporeal life support or high-frequency oscillatory ventilation 5. Weight \> 150 kg 6. Current severe chronic respiratory disease, as demonstrated by: 1. PaCO2 \> 50 mm Hg, or 2. history of use of home oxygen 7. Major trauma within the past 7 days 8. Lung transplant recipient 9. WHO Class III or IV pulmonary hypertension 10. Documented deep vein thrombosis or pulmonary embolism within the past 3 months 11. Currently pregnant or lactating 12. Currently participating in another clinical trial, or participation in another clinical trial within 30 days of enrollment 13. Hypersensitivity to Dextran-40 or Dimethyl Sulfoxide (DMSO) 14. Current pharmacotherapy using hydroxychloroquine or Interleukin-6 inhibitors 15. History of CVA or MI within 180 days of study enrollment