Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of Severe COVID-19

This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.

Key Inclusion Criteria:

• Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.
• Male or non-pregnant female adult 40-80 years of age at time of enrollment.
• Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to 21 days prior to randomization.
• Meets definition of ARDS according to Berlin criteria.

Key Exclusion Criteria:

• Body weight under 55 kg (121 lbs)
• Serum creatinine level of over 1.5 mg/dL at time of randomization.
• Total Bilirubin ≥2 mg/dL at time of randomization.
• Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin.
• Stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization.
• Chronic Obstructive Pulmonary disease GOLD stage above II.