Allogeneic Natural Killer (NK) Cell Therapy in Subjects Hospitalized for COVID-19

Inclusion criteria

• Be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
• Be between 18 and 80 years of age and weigh at least 40 kg, inclusive, at time of informed consent
• Be confirmed positive for COVID-19 (SARS-CoV-2) infection as determined by validated clinical PCR assay or by a hospital validated serological test within 7 days of consent
• Symptomatic onset within 7 days of signing consent
• Require hospitalization and meet the following:

• Radiographic infiltrates by imaging (chest x-ray, CT scans)
• Able to maintain a SpO2 ≥ 93% at rest. Supplemental oxygen to a maximum 4L by low flow O2-delivery is allowed, but not required
• Meet 2 out of the 3 following criteria:

i. IL-6 < 150 pg/mL ii. CRP < 100 mg/L (10 mg/dL) iii. Ferritin < 1000 ng/mL

• Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study and for a minimum of 90 days after study treatment

Exclusion criteria

• Weight less than 40 kg
• Be ventilator dependent or be diagnosed with ARDS or multi-system organ failure
• Have elevated oxygen requirement exceeding 4L oxygen by nasal cannula
• Expected intubation within 24 hours per investigators assessment
• Expected discharge from hospital within 72 hours of planned DVX201 date of infusion
• Have a known hypersensitivity to constituents of DVX201, such as DMSO or atinhistamine medications
• Have a history of symptomatic pulmonary or chronic pulmonary disease or severe asthma on chronic therapy for treatment
• Have a history of baseline requirement of supplemental oxygen prior to COVID-19 diagnosis
• Active autoimmune disorder or other medical condition requiring systemic immunosuppressive therapy (including steroids at > 5 mg prednisone or equivalent daily)
• Be pregnant or breast-feeding
• Have inadequate organ function as defined by:

• Acute or chronic kidney injury requiring intermittent or continuous venovenous hemodialysis or estimated GFR of < 60 mL/min/1.73 m2
• Abnormal liver function defined by AST (aspartate aminotransferase), ALT (alanine aminotransferase) or alkaline phosphatase ≥ 5 times the upper limit of normal