Open-label Multicenter Study to Evaluate the Efficacy of PLX-PAD for the Treatment of COVID-19

October 9, 2023 updated by: Pluristem Ltd.

A Randomized, Controlled, Multicenter, Parallel-Group Phase IIa 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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charite Campus Virchow
      • Berlin, Germany, 12203
        • Campus Benjamin Franklin - CBF Charité - Universitätsmedizin
      • Bonn, Germany, 53127
        • University of hospital Bonn
      • Köln, Germany, 51109
        • Hospital Cologne-Merheim
  • Israel
      • Afula, Israel, 1834111
        • Emek Medical Center
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center
      • Nahariya, Israel, 22100
        • Galilee Medical Center
      • Tiberias, Israel, 15208
        • Baruch Padeh Medical center, Poriya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 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 18-85 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PLX-PAD Treatment

PLX-PAD 300 million cells (20 million/mL) administered via 15 IM injections (1 mL each).

Single administration in addition to best standard medical care.
Biological: PLX-PAD
PLX-PAD - allogeneic ex-vivo expanded placental mesenchymal-like adherent stromal cells
No Intervention: Control Group
Best standard medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of ventilator-free days
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 28 and 60 days
28 and 60 days
Duration of mechanical ventilation
Time Frame: 28 and 60 days
28 and 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pluristem Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2020

Primary Completion (Actual)

August 4, 2021

Study Completion (Actual)

February 7, 2023

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • PLX-COV-03

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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