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

Purpose

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.

Conditions

  • COVID
  • ARDS

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04389450
Status
Terminated
Sponsor
Pluristem Ltd.