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

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ClinicalTrials.gov Identifier: NCT04389450
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Pluristem Ltd.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COVID ARDS Biological: PLX-PAD Biological: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : March 2022
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of ventilator free days [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 28 days ]
  2. Duration of mechanical ventilation [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04389450


Locations
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United States, California
University of California Irvine Recruiting
Irvine, California, United States, 92868
Contact: Leonid Groysman, MD    562-826-5831    lgroysma@hs.uci.edu   
University of Southern California (USC) - Keck School of Medicine (KSOM) Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Sivagini Ganesh, MD    323-409-7594    Sivagini.Ganesh@med.usc.edu   
University Of California Davis,4860 Y Street Not yet recruiting
Sacramento, California, United States, 95817
Contact: Christian E Sandrock, MD    916-734-3351    cesandrock@UCDAVIS.EDU   
United States, Florida
Baptist Health Medical Center Recruiting
Jacksonville, Florida, United States, 32207
Contact: Eddy J Gutierrez, Dr    904-202-3885    Eddy.Gutierrez@bmcjax.com   
United States, Georgia
Medical College of Georgia at Augusta University Not yet recruiting
Augusta, Georgia, United States, 30907
Contact: Rabih I Bechara,, MD    706-721-5636    rbechara@augusta.edu   
Sarah Cannon Research Institute, LLC (Mercer University School of Medicine) Recruiting
Macon, Georgia, United States, 31217
Contact: Jennifer C Hoffman,, MD    615-329-7635    hoffman_jc@mercer.edu   
United States, Mississippi
University of Mississippi Medical Center Not yet recruiting
Jackson, Mississippi, United States, 39216
Contact: Luis A Shimose Ciudad, MD    601-984-5560    lshimoseciudad@umc.edu   
United States, New Jersey
Cooper Research Institute Not yet recruiting
Camden, New Jersey, United States, 08103
Contact: Nitin Puri, MD    856-536-1030    puri-nitin@CooperHealth.edu   
Holy Medical Center Recruiting
Teaneck, New Jersey, United States, 07666
Contact: Suraj Saggar, Dr.    201-503-0660    surajsaggar@hotmail.com   
United States, New York
Montefiore Medical Center Not yet recruiting
New York, New York, United States, 10467
Contact: Harish Seethamraju, MD    718-920-6546    hseetham@montefiore.org   
Maimonides Medical Center Recruiting
New York, New York, United States, 11219
Contact: Paul Sanders, MD    718-283-7686    PaSaunders@maimonidesmed.org   
Mercy Medical Center Recruiting
New York, New York, United States, 11570
Contact: Maqsood Alam, MD    516-974-5177    MAQS687@yahoo.com   
United States, Pennsylvania
Thomas Jefferson University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: George Gautam, Dr.    215-955-5161    Gautam.George@jefferson.edu   
Sponsors and Collaborators
Pluristem Ltd.
More Information
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Additional Information:

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Responsible Party: Pluristem Ltd.
ClinicalTrials.gov Identifier: NCT04389450    
Other Study ID Numbers: PLX-COV-01
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No