Tregs for the Treatment of Acute Respiratory Distress Syndrome (ARDS) Associated With COVID-19 (regARDS)

Inclusion Criteria: * Diagnosis of ARDS and respiratory failure requiring mechanical ventilation for less than 72 hours at the time of enrollment * PaO2/FiO2 \< 300 and PEEP \> 5 * Male or female, age 18 to 70 years at Screening * Weight \> 40 kg * Documented diagnosis of infection with SARS-CoV-2 virus by PCR * Chest imaging (radiograph or CT scan) with abnormalities consistent with COVID-19 pneumonia that could not be explained by effusions, pulmonary collapse, or nodules; and respiratory failure that could not be explained by cardiac failure or fluid overload * Females of childbearing potential and males must use effective contraception practices from Screening until 28 days after the EOS visit * Females of childbearing potential must have a negative pregnancy test at Screening and within 24 hours prior to dosing of study drug * Able to provide Informed Consent, either by self or by medical proxy * Willing and able to comply with this protocol for the entire duration of the study Exclusion Criteria: * Any history or sign of significant chronic active or recurrent infection or screening laboratory evidence consistent with a significant chronic active or recurrent infection requiring treatment with antibiotics, antivirals or antifungals (other than SARS-CoV-2); ongoing antimicrobial treatments will not be exclusionary if, in the opinion of the investigator, no active infection is present (other than SARS-CoV-2) * Receiving extracorporeal membrane oxygenation therapy * Mor…