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

Phase 2

Terminated

• Conditions: ARDS; COVID
• Interventions: Biological: PLX-PAD

• Registration Number: NCT04614025
• Lead Sponsor: Pluristem Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-19
• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-03
• Primary Completion: 2021-08-04
• Study Completion: 2023-02-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLX-PAD Treatment	PLX-PAD	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.

Primary Outcome Measures

Name	Time	Method
Number of ventilator-free days	28 days

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Charite Campus Virchow; 🇩🇪 Berlin, Germany

Campus Benjamin Franklin - CBF Charité - Universitätsmedizin; 🇩🇪 Berlin, Germany

University of hospital Bonn; 🇩🇪 Bonn, Germany

Hospital Cologne-Merheim; 🇩🇪 Köln, Germany

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, Israel