Cellular Immuno-Therapy for COVID-19 ARDS Randomized Clinical Trial

Inclusion Criteria:

• Age of ≥18 years

• Laboratory-confirmed SARS-CoV-2 infection during the current admission

• On invasive, non-invasive mechanical ventilation (NIV) (PEEP ≥5 cmH20) or high-flownasal canula (HFNC) oxygen therapy (minimum total flow rate of 40 lpm)

• ARDS (onset <96h) as per the international consensus definition (P/F ratio < 300with PEEP ≥5cm H20 or on HFNC), not due primarily to cardiac causes.

Exclusion Criteria:

• No consent/inability to obtain consent

• Rockwood Clinical Frailty Score > 4

• Moribund patient not expected to survive 24 hours

• Any other irreversible disease or condition for which 6-month mortality is estimatedto be greater than 50%

• Currently receiving extracorporeal life support

• Pregnant or lactating

• Patients with a prior or concurrent malignancy whose natural history or treatmentdoes not have the potential to interfere with the safety or efficacy assessment ofthe investigational regimen are eligible for this trial

• Moderate to severe chronic liver disease (Childs-Pugh Score > 12)

• Severe chronic respiratory disease with a baseline PaCO2 > 50 mm Hg or the use ofhome oxygen

• Documented deep venous thrombosis or pulmonary embolism within the preceding 3months

• Inability/contra-indications to receiving local standard of care thromboprophylaxis

• Chronic immunosuppression (any chronic immunotherapy including daily oral steroiduse >6months)

• Known HIV, Hep B/C positive, or active tuberculosis

• Multisystem shock (SOFA score change from baseline of >2 in >2 systems)

• Patient, surrogate, or physician not committed to full support including intubation (exception: a patient will not be excluded if he/she would receive all supportivecare except for attempts at resuscitation from cardiac arrest)