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

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04614025
• Other study ID #: PLX-COV-03
• Status: Terminated
• Phase: Phase 2
• Start date: October 19, 2020
• Est. completion date: February 7, 2023

Study information

• Verified date: October 2023
• 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: 23
• Est. completion date: February 7, 2023
• Est. primary completion date: August 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 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 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.

Related Conditions & MeSH terms

• ARDS
• COVID

Intervention

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

Locations

Country	Name	City	State
Germany	Campus Benjamin Franklin - CBF Charité - Universitätsmedizin	Berlin
Germany	Charite Campus Virchow	Berlin
Germany	University of hospital Bonn	Bonn
Germany	Hospital Cologne-Merheim	Köln
Israel	Emek Medical Center	Afula
Israel	Bnai Zion Medical Center	Haifa
Israel	Rambam Health Care Campus	Haifa
Israel	Galilee Medical Center	Nahariya
Israel	Baruch Padeh Medical Center, Poriya	Tiberias

Sponsors (1)

Lead Sponsor	Collaborator
Pluristem Ltd.

Countries where clinical trial is conducted

Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ventilator-free days		28 days
Secondary	All-cause mortality		28 and 60 days
Secondary	Duration of mechanical ventilation		28 and 60 days

External Links

•   Related Info