Back to resultsMultiStem Administration for COVID-19 Induced ARDS (MACoVIA) (MACoVIA)
Primary Purpose
ARDS
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MultiStem
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for ARDS focused on measuring COVID19, respiratory distress, adult stem cells
Eligibility Criteria
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
Sites / Locations
- Athersys Investigational Site 107Recruiting
- Athersys Investigational Site 103Recruiting
- Athersys Investigational Site 101Recruiting
- Athersys Investigational Site 102Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MultiStem
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Ventilator-Free Days
Safety and Tolerability as measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0.
Secondary Outcome Measures
All-cause mortality
Ranked hierarchical composite outcome of alive and ventilator-free
Ventilator-free days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04367077
Brief Title
MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)
Acronym
MACoVIA
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2020 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Athersys, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS
Keywords
COVID19, respiratory distress, adult stem cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MultiStem
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
MultiStem
Intervention Description
intravenous infusion
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
intravenous infusion
Primary Outcome Measure Information:
Title
Ventilator-Free Days
Time Frame
Day 0 through Day 28.
Title
Safety and Tolerability as measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
Day 60
Title
Ranked hierarchical composite outcome of alive and ventilator-free
Time Frame
Day 28
Title
Ventilator-free days
Time Frame
Day 0 through Day 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Athersys Clinical Trials Group
Phone
2164263597
Email
macovia@athersys.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Jenkins, MD
Organizational Affiliation
Athersys, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Athersys Investigational Site 107
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials Group
Phone
216-426-3597
Email
macovia@athersys.com
Facility Name
Athersys Investigational Site 103
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials Group
Phone
216-426-3597
Email
macovia@athersys.com
Facility Name
Athersys Investigational Site 101
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials Group
Phone
216-426-3597
Email
macovia@athersys.com
Facility Name
Athersys Investigational Site 102
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athersys Clinical Trials Group
Phone
216-426-3597
Email
macovia@athersys.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)
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