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

Pluri (Pluristem Therapeutics)

Status and phase: Terminated; Phase 2

Conditions: COVID; ARDS

Treatments: Biological: PLX-PAD; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04389450

PLX-COV-01

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 5 patient groups, including a placebo group

PLX-PAD interval high dose

Experimental group

Description:

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.

Treatment:

Biological: PLX-PAD

PLX-PAD low dose

Experimental group

Description:

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

Treatment:

Biological: PLX-PAD

Control Group A

Placebo Comparator group

Description:

Placebo, two administrations, 1 week apart

Treatment:

Biological: Placebo

PLX-PAD high dose

Experimental group

Description:

PLX-PAD, single administration

Treatment:

Biological: PLX-PAD

Control Group B

Placebo Comparator group

Description:

Placebo, single administration

Treatment:

Biological: Placebo