NCT04614025|TerminatedPhase 2DMC

Study Stopped

The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients.

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

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

Pluristem Ltd.ClinicalTrials.gov

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1 other identifier

PLX-COV-03

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredNov 2020

StartedOct 2020

CompletionFeb 2023

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Oct 2020

Geographic Reach

2 countries

9 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

Study Start

First participant enrolled

October 19, 2020

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

November 2, 2020

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2021

Completed

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2023

Completed

Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

November 2, 2020

Last Update Submit

August 28, 2024

Conditions

COVID ARDS

Outcome Measures

Primary Outcomes (1)

Number of ventilator-free days
28 days

Secondary Outcomes (2)

All-cause mortality
28 and 60 days
Duration of mechanical ventilation
28 and 60 days

Study Arms (2)

PLX-PAD Treatment

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Best standard medical care

Interventions

PLX-PADBIOLOGICAL

PLX-PAD - allogeneic ex-vivo expanded placental mesenchymal-like adherent stromal cells

PLX-PAD Treatment

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pluristem Ltd.lead

Study Sites (9)

Charite Campus Virchow

Berlin, 10117, Germany

Location

Campus Benjamin Franklin - CBF Charité - Universitätsmedizin

Berlin, 12203, Germany

Location

University of hospital Bonn

Bonn, 53127, Germany

Location

Hospital Cologne-Merheim

Cologne, 51109, Germany

Location

Emek Medical Center

Afula, 1834111, Israel

Location

Bnai Zion Medical Center

Haifa, 31048, Israel

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Galilee Medical Center

Nahariya, 22100, Israel

Location

Baruch Padeh Medical Center, Poriya

Tiberias, 15208, Israel

Location

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 3, 2020

Study Start

October 19, 2020

Primary Completion

August 4, 2021

Study Completion

February 7, 2023

Last Updated

August 29, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing: Will not share

Locations

IL(5)DE(4)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

PLX-PAD Treatment

Control Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Links

Study Design

Study Record Dates

Data Sharing

Locations