Status:
TERMINATED
Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19
Lead Sponsor:
Pluristem Ltd.
Conditions:
COVID
ARDS
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04389450
Start Date
October 1 2020
End Date
June 7 2023
Last Update
August 30 2024
Active Locations (13)
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1
University of California Irvine
Irvine, California, United States, 92868
2
University of Southern California (USC) - Keck School of Medicine (KSOM)
Los Angeles, California, United States, 90033
3
University Of California Davis,4860 Y Street
Sacramento, California, United States, 95817
4
Baptist Health Medical Center
Jacksonville, Florida, United States, 32207