Clincosm LogoSign in Get a demo

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

Sponsor
Pluristem Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04389450
Collaborator
(none)
66
Enrollment
13
Locations
5
Arms
20
Anticipated Duration (Months)
5.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: PLX-PAD
  • Biological: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
May 17, 2021
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Biological: PLX-PAD
PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
Experimental: PLX-PAD low dose

PLX-PAD 300, single administration, second administration of placebo after 1 week.

Biological: PLX-PAD
PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
Placebo Comparator: Control Group A

Placebo, two administrations, 1 week apart

Biological: Placebo
Placebo solution for injection
Experimental: PLX-PAD high dose

PLX-PAD, single administration

Biological: PLX-PAD
PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
Placebo Comparator: Control Group B

Placebo, single administration

Biological: Placebo
Placebo solution for injection

Outcome Measures

Primary Outcome Measures

  1. Number of ventilator free days [28 days]

Secondary Outcome Measures

  1. All-cause mortality [28 days]

  2. Duration of mechanical ventilation [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California Irvine Irvine California United States 92868
2 University of Southern California (USC) - Keck School of Medicine (KSOM) Los Angeles California United States 90033
3 University Of California Davis,4860 Y Street Sacramento California United States 95817
4 Baptist Health Medical Center Jacksonville Florida United States 32207
5 Medical College of Georgia at Augusta University Augusta Georgia United States 30907
6 Sarah Cannon Research Institute, LLC (Mercer University School of Medicine) Macon Georgia United States 31217
7 University of Mississippi Medical Center Jackson Mississippi United States 39216
8 Cooper Research Institute Camden New Jersey United States 08103
9 Holy Medical Center Teaneck New Jersey United States 07666
10 Montefiore Medical Center New York New York United States 10467
11 Maimonides Medical Center New York New York United States 11219
12 Mercy Medical Center New York New York United States 11570
13 Thomas Jefferson University Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Pluristem Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pluristem Ltd.
ClinicalTrials.gov Identifier:
NCT04389450
Other Study ID Numbers:
  • PLX-COV-01
First Posted:
May 15, 2020
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 11, 2022