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 40years - 80years
Treatment Placebo, PLX-PAD
Clinical Study IdentifierNCT04389450
SponsorPluristem Ltd.
Last Modified on19 February 2024

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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