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.

Study Overview

• Status: Terminated
• Conditions: COVID; ARDS
• Intervention / Treatment: Biological: PLX-PAD; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92868
      • University of California Irvine
    • Los Angeles, California, United States, 90033
      • University of Southern California (USC) - Keck School of Medicine (KSOM)
    • Sacramento, California, United States, 95817
      • University Of California Davis,4860 Y Street
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Health Medical Center
  • Georgia
    • Augusta, Georgia, United States, 30907
      • Medical College of Georgia at Augusta University
    • Macon, Georgia, United States, 31217
      • Sarah Cannon Research Institute, LLC (Mercer University School of Medicine)
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper Research Institute
    • Teaneck, New Jersey, United States, 07666
      • Holy Medical Center
  • New York
    • New York, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 11219
      • Maimonides Medical Center
    • New York, New York, United States, 11570
      • Mercy Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PLX-PAD interval high dose; 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; PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
Experimental: PLX-PAD low dose; PLX-PAD 300, single administration, second administration of placebo after 1 week.	Biological: PLX-PAD; PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
Placebo Comparator: Control Group A; Placebo, two administrations, 1 week apart	Biological: Placebo; Placebo solution for injection
Experimental: PLX-PAD high dose; PLX-PAD, single administration	Biological: PLX-PAD; PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
Placebo Comparator: Control Group B; Placebo, single administration	Biological: Placebo; Placebo solution for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of ventilator free days	28 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pluristem Ltd.

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): May 17, 2021
• Study Completion (Actual): June 7, 2023

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PLX-COV-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No