MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)
MACoVIA
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)
1 other identifier
interventional
400
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2020
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2020
CompletedStudy Start
First participant enrolled
April 28, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedSeptember 9, 2021
September 1, 2021
2.7 years
April 27, 2020
September 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
All-cause mortality
Day 60
Ranked hierarchical composite outcome of alive and ventilator-free
Day 28
Ventilator-free days
Day 0 through Day 60
Study Arms (2)
MultiStem
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Healios K.K.lead
Study Sites (4)
Athersys Investigational Site 107
Chicago, Illinois, 60601, United States
Athersys Investigational Site 103
Akron, Ohio, 44304, United States
Athersys Investigational Site 101
Cleveland, Ohio, 44106, United States
Athersys Investigational Site 102
Cleveland, Ohio, 44109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eric Jenkins, MD
Healios K.K.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2020
First Posted
April 29, 2020
Study Start
April 28, 2020
Primary Completion
January 1, 2023
Study Completion
December 1, 2023
Last Updated
September 9, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share