Clinical trial NCT04389450: Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID
ARDS
Lead sponsor: Pluristem Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-15
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of ventilator free days
timeFrame: 28 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 28 days
measure: Duration of mechanical ventilation
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Los Angeles
country: United States
facility: University of Southern California (USC) - Keck School of Medicine (KSOM)
state: California
city: Sacramento
country: United States
facility: University Of California Davis,4860 Y Street
state: California
city: Jacksonville
country: United States
facility: Baptist Health Medical Center
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia at Augusta University
state: Georgia
city: Macon
country: United States
facility: Sarah Cannon Research Institute, LLC (Mercer University School of Medicine)
state: Georgia
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Camden
country: United States
facility: Cooper Research Institute
state: New Jersey
city: Teaneck
country: United States
facility: Holy Medical Center
state: New Jersey
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Maimonides Medical Center
state: New York
city: New York
country: United States
facility: Mercy Medical Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References: