Brief Summary
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.
Brief Title
Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19
Completion Date
Completion Date Type
Actual
Conditions
COVID
ARDS
Eligibility 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.
* 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.
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
40 Years
NCT Id
NCT04389450
Org Class
Industry
Org Full Name
Pluristem Ltd.
Org Study Id
PLX-COV-01
Overall Status
Terminated
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of Severe COVID-19
Primary Outcomes
Outcome Measure
Number of ventilator free days
Outcome Time Frame
28 days
Secondary Outcomes
Outcome Time Frame
28 days
Outcome Measure
All-cause mortality
Outcome Time Frame
8 weeks
Outcome Measure
Duration of mechanical ventilation
See Also Links
Url
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
40
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ali Mansour
Investigator Email
amansour@montefiore.org
Investigator Phone
MeSH Terms
COUNTERFEIT DRUGS
SUBSTANDARD DRUGS
PHARMACEUTICAL PREPARATIONS