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

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ClinicalTrials.gov Identifier: NCT04389450
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Pluristem Ltd.

Tracking Information
First Submitted Date  ICMJE May 14, 2020
First Posted Date  ICMJE May 15, 2020
Last Update Posted Date October 29, 2020
Actual Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2020)		 Number of ventilator free days [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2020)
  • All-cause mortality [ Time Frame: 28 days ]
  • Duration of mechanical ventilation [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of Severe COVID-19
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID
  • ARDS
Intervention  ICMJE
  • Biological: PLX-PAD
    PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
  • Biological: Placebo
    Placebo solution for injection
Study Arms  ICMJE
  • Experimental: PLX-PAD interval high dose
    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.
    Intervention: Biological: PLX-PAD
  • Experimental: PLX-PAD low dose
    PLX-PAD 300, single administration, second administration of placebo after 1 week.
    Intervention: Biological: PLX-PAD
  • Placebo Comparator: Control Group A
    Placebo, two administrations, 1 week apart
    Intervention: Biological: Placebo
  • Experimental: PLX-PAD high dose
    PLX-PAD, single administration
    Intervention: Biological: PLX-PAD
  • Placebo Comparator: Control Group B
    Placebo, single administration
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2020)		 140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries Israel
 
Administrative Information
NCT Number  ICMJE NCT04389450
Other Study ID Numbers  ICMJE PLX-COV-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pluristem Ltd.
Study Sponsor  ICMJE Pluristem Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pluristem Ltd.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP