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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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COVID, ARDS

Intervention / Treatment
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* Biological: PLX-PAD
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLX-PAD interval high dose<br>PLX-PAD will be administered via 15 IM injections (1 mL each). Each subject will be treated twice, with an interval of 1 week between treatments. | Biological: PLX-PAD<br>* PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells<br>|
| Experimental: PLX-PAD low dose<br>PLX-PAD 300, single administration, second administration of placebo after 1 week. | Biological: PLX-PAD<br>* PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells<br>|
| Placebo Comparator: Control Group A<br>Placebo, two administrations, 1 week apart | Biological: Placebo<br>* Placebo solution for injection<br>|
| Experimental: PLX-PAD high dose<br>PLX-PAD, single administration | Biological: PLX-PAD<br>* PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells<br>|
| Placebo Comparator: Control Group B<br>Placebo, single administration | Biological: Placebo<br>* Placebo solution for injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ventilator free days |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 28 days | 
| Duration of mechanical ventilation |  | 8 weeks |