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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04614025
Recruitment Status : Active, not recruiting
First Posted : November 3, 2020
Last Update Posted : August 10, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COVID ARDS Biological: PLX-PAD Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 19, 2020
Actual Primary Completion Date : August 4, 2021
Estimated Study Completion Date : September 2022

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



Primary Outcome Measures :
  1. Number of ventilator-free days [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 28 and 60 days ]
  2. Duration of mechanical ventilation [ Time Frame: 28 and 60 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04614025


Locations
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Germany
Charite Campus Virchow
Berlin, Germany, 10117
Campus Benjamin Franklin - CBF Charité - Universitätsmedizin
Berlin, Germany, 12203
University of hospital Bonn
Bonn, Germany, 53127
Hospital Cologne-Merheim
Köln, Germany, 51109
Israel
Emek Medical Center
Afula, Israel, 1834111
Bnai Zion Medical Center
Haifa, Israel, 31048
Rambam Health Care Campus
Haifa, Israel, 3109601
Galilee Medical Center
Nahariya, Israel, 22100
Baruch Padeh Medical Center, Poriya
Tiberias, Israel, 15208
Sponsors and Collaborators
Pluristem Ltd.
Additional Information:
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Responsible Party: Pluristem Ltd.
ClinicalTrials.gov Identifier: NCT04614025    
Other Study ID Numbers: PLX-COV-03
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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