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

COVID Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04389450
• Other study ID #: PLX-COV-01
• Status: Terminated
• Phase: Phase 2
• Start date: October 1, 2020
• Est. completion date: June 7, 2023

Study information

• Verified date: January 2022
• Source: Pluristem Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: June 7, 2023
• Est. primary completion date: May 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• ARDS
• COVID

Intervention

Biological:
• PLX-PAD
PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
• Placebo
Placebo solution for injection

Locations

Country	Name	City	State
United States	Medical College of Georgia at Augusta University	Augusta	Georgia
United States	Cooper Research Institute	Camden	New Jersey
United States	University of California Irvine	Irvine	California
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Baptist Health Medical Center	Jacksonville	Florida
United States	University of Southern California (USC) - Keck School of Medicine (KSOM)	Los Angeles	California
United States	Sarah Cannon Research Institute, LLC (Mercer University School of Medicine)	Macon	Georgia
United States	Maimonides Medical Center	New York	New York
United States	Mercy Medical Center	New York	New York
United States	Montefiore Medical Center	New York	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University Of California Davis,4860 Y Street	Sacramento	California
United States	Holy Medical Center	Teaneck	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Pluristem Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ventilator free days		28 days
Secondary	All-cause mortality		28 days
Secondary	Duration of mechanical ventilation		8 weeks

External Links

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