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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2023-02-07

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID ARDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PLX-PAD

Intervention Type BIOLOGICAL

PLX-PAD - allogeneic ex-vivo expanded placental mesenchymal-like adherent stromal cells

Control Group

Best standard medical care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PLX-PAD

PLX-PAD - allogeneic ex-vivo expanded placental mesenchymal-like adherent stromal cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No