ARDS
Conditions
Keywords
COVID19, respiratory distress, adult stem cells
Brief summary
Multicenter investigation featuring an open-label lead-in followed by a double blinded, randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy of MultiStem therapy in subjects with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to pathogens including COVID-19.
Interventions
BIOLOGICALMultiStem
intravenous infusion
BIOLOGICALPlacebo
intravenous infusion
Sponsors
Healios K.K.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of new acute-onset moderate to severe ARDS, as defined by the Berlin criteria, requiring an endotracheal or tracheal tube, Evidence of pneumonia or severe localized or systemic infection
Exclusion criteria
Moribund subject who, in the opinion of the Investigator, is not expected to survive at least 48 hours and End-stage severe chronic lung disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ventilator-Free Days | Day 0 through Day 28. |
| Safety and Tolerability as measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0. | Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality | Day 60 |
| Ranked hierarchical composite outcome of alive and ventilator-free | Day 28 |
| Ventilator-free days | Day 0 through Day 60 |
Countries
United States
Contacts
STUDY_DIRECTOREric Jenkins, MD
Healios K.K.
Outcome results
None listed