Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19

Phase 2

Terminated

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

• Registration Number: NCT04389450
• 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 First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-15
• Study Start: 2020-10-01
• Primary Completion: 2021-05-17
• Study Completion: 2023-06-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 66

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.

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
Control Group A	Placebo	Placebo, two administrations, 1 week apart
PLX-PAD interval high dose	PLX-PAD	PLX-PAD will be administered via 15 IM injections (1 mL each). Each subject will be treated twice, with an interval of 1 week between treatments.
PLX-PAD high dose	PLX-PAD	PLX-PAD, single administration
PLX-PAD low dose	PLX-PAD	PLX-PAD 300, single administration, second administration of placebo after 1 week.
Control Group B	Placebo	Placebo, single administration

Primary Outcome Measures

Name	Time	Method
Number of ventilator free days	28 days

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	28 days
Duration of mechanical ventilation	8 weeks

Trial Locations

Locations (13)

Mercy Medical Center; 🇺🇸 New York, New York, United States

Medical College of Georgia at Augusta University; 🇺🇸 Augusta, Georgia, United States

Cooper Research Institute; 🇺🇸 Camden, New Jersey, United States

University of Southern California (USC) - Keck School of Medicine (KSOM); 🇺🇸 Los Angeles, California, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

University of California Irvine; 🇺🇸 Irvine, California, United States

Sarah Cannon Research Institute, LLC (Mercer University School of Medicine); 🇺🇸 Macon, Georgia, United States

Holy Medical Center; 🇺🇸 Teaneck, New Jersey, United States

Baptist Health Medical Center; 🇺🇸 Jacksonville, Florida, United States

University Of California Davis,4860 Y Street; 🇺🇸 Sacramento, California, United States

Maimonides Medical Center; 🇺🇸 New York, New York, United States

Montefiore Medical Center; 🇺🇸 New York, New York, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States