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

STATUS

Recruiting
participants needed

140
sponsor

Pluristem Ltd.

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Updated on 19 February 2024

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respiratory distress

covid-19

SARS

acute respiratory distress

acute respiratory syndrome (sars)

Summary

This clinical trial will examine if a new treatment of Mesenchymal Stems Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.

Details

Condition	ADULT RESPIRATORY DISTRESS SYNDROME, COVID
Age	40-80 years
Treatment	Placebo, PLX-PAD
Clinical Study Identifier	NCT04389450
Sponsor	Pluristem Ltd.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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