Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress

Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells

This is a Phase 2 study to assess COVI-MSC in the setting of current standard of care in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute respiratory distress / acute respiratory distress syndrome.

This is a Phase 2 multicenter (United States and Mexico) study to assess the safety and preliminary efficacy of COVI-MSC in the setting of current standard of care in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute respiratory stress (ARD) / acute respiratory distress syndrome (ARDS).

Subjects will be randomized 1:1 COVI-MSC to placebo. COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4.

Inclusion Criteria:

• Laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen (can be documented from inpatient medical record)
• Hospitalized with at least "severe" COVID-19-induced ARD or ARDS as defined per FDA Guidance; COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
• Requires oxygen supplementation at Screening
• Willing to follow contraception guidelines

Exclusion Criteria:

• Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving
• Has severe ARDS with a PaO2/FiO2 (PF ratio) ≤ 100 mmHg or SpO2/FiO2 ratio < 150 mmHg with PEEP ≥ 5cm H2O
• A previous stem cell infusion unrelated to this trial
• Pregnant or breast feeding or planning for either during the study
• Suspected uncontrolled active bacterial, fungal, viral, or other infection (aside from infection with COVID-19)
• History of a splenectomy, lung transplant or lung lobectomy
• Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
• Expected survival or time to withdrawal of life-sustaining treatments expected to be < 7 days
• Has an existing "Do Not Intubate" order
• Has undergone home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing (eg, obstructive sleep apnea)
• Has any significant medical condition, laboratory abnormality or psychiatric illness that in the investigator's opinion would interfere or prevent the subject from safely participating in the study