ARDS, COVID
Conditions
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.
Interventions
BIOLOGICALPlacebo
Placebo solution for injection
BIOLOGICALPLX-PAD
PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
Sponsors
Pluristem Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of ventilator free days | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality | 28 days |
| Duration of mechanical ventilation | 8 weeks |
Countries
United States
Outcome results
None listed