Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19
NCT ID: NCT04389450
Last Updated: 2024-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
66 participants
INTERVENTIONAL
2020-10-01
2023-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
PLX-PAD
PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
PLX-PAD low dose
PLX-PAD 300, single administration, second administration of placebo after 1 week.
PLX-PAD
PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
Control Group A
Placebo, two administrations, 1 week apart
Placebo
Placebo solution for injection
PLX-PAD high dose
PLX-PAD, single administration
PLX-PAD
PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
Control Group B
Placebo, single administration
Placebo
Placebo solution for injection
Interventions
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PLX-PAD
PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
Placebo
Placebo solution for injection
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
40 Years
80 Years
ALL
No
Sponsors
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Pluristem Ltd.
INDUSTRY
Responsible Party
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Locations
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University of California Irvine
Irvine, California, United States
University of Southern California (USC) - Keck School of Medicine (KSOM)
Los Angeles, California, United States
University Of California Davis,4860 Y Street
Sacramento, California, United States
Baptist Health Medical Center
Jacksonville, Florida, United States
Medical College of Georgia at Augusta University
Augusta, Georgia, United States
Sarah Cannon Research Institute, LLC (Mercer University School of Medicine)
Macon, Georgia, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Cooper Research Institute
Camden, New Jersey, United States
Holy Medical Center
Teaneck, New Jersey, United States
Montefiore Medical Center
New York, New York, United States
Maimonides Medical Center
New York, New York, United States
Mercy Medical Center
New York, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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Related Info
Other Identifiers
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PLX-COV-01
Identifier Type: -
Identifier Source: org_study_id
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