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Clinical Trials/NCT04367077
NCT04367077TerminatedPhase 2

A Phase 2/3 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease (COVID-19)

Healios K.K.4 sites in 1 country206 target enrollmentStarted: April 28, 2020Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
206
Locations
4
Primary Endpoint
Ventilator-Free Days
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 89 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

MultiStem

Experimental

Intervention: MultiStem (Biological)

Placebo

Placebo Comparator

Intervention: Placebo (Biological)

Outcomes

Primary Outcomes

Ventilator-Free Days

Time Frame: Day 0 through Day 28.

Safety and Tolerability as measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0.

Time Frame: Day 28

Secondary Outcomes

  • All-cause mortality(Day 60)
  • Ranked hierarchical composite outcome of alive and ventilator-free(Day 28)
  • Ventilator-free days(Day 0 through Day 60)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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