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

Pluristem Ltd.13 sites in 1 country66 target enrollmentOctober 1, 2020

ConditionsCOVID ARDS

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: COVID
Sponsor: Pluristem Ltd.
Enrollment: 66
Locations: 13
Primary Endpoint: Number of ventilator free days
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2020

End Date

June 7, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pluristem Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.

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.