Study Stopped
The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients
Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19
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
1 other identifier
interventional
66
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2020
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2020
CompletedFirst Posted
Study publicly available on registry
May 15, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2023
CompletedAugust 30, 2024
August 1, 2024
8 months
May 14, 2020
August 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of ventilator free days
28 days
Secondary Outcomes (2)
All-cause mortality
28 days
Duration of mechanical ventilation
8 weeks
Study Arms (5)
PLX-PAD interval high dose
EXPERIMENTALPLX-PAD will be administered via 15 IM injections (1 mL each). Each subject will be treated twice, with an interval of 1 week between treatments.
PLX-PAD low dose
EXPERIMENTALPLX-PAD 300, single administration, second administration of placebo after 1 week.
Control Group A
PLACEBO COMPARATORPlacebo, two administrations, 1 week apart
PLX-PAD high dose
EXPERIMENTALPLX-PAD, single administration
Control Group B
PLACEBO COMPARATORPlacebo, single administration
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pluristem Ltd.lead
Study Sites (13)
University of California Irvine
Irvine, California, 92868, United States
University of Southern California (USC) - Keck School of Medicine (KSOM)
Los Angeles, California, 90033, United States
University Of California Davis,4860 Y Street
Sacramento, California, 95817, United States
Baptist Health Medical Center
Jacksonville, Florida, 32207, United States
Medical College of Georgia at Augusta University
Augusta, Georgia, 30907, United States
Sarah Cannon Research Institute, LLC (Mercer University School of Medicine)
Macon, Georgia, 31217, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Cooper Research Institute
Camden, New Jersey, 08103, United States
Holy Medical Center
Teaneck, New Jersey, 07666, United States
Montefiore Medical Center
New York, New York, 10467, United States
Maimonides Medical Center
New York, New York, 11219, United States
Mercy Medical Center
New York, New York, 11570, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Related Links
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2020
First Posted
May 15, 2020
Study Start
October 1, 2020
Primary Completion
May 17, 2021
Study Completion
June 7, 2023
Last Updated
August 30, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share