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MultiStem Administration for COVID-19 Induced ARDS (MACoVIA) (MACoVIA)

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ClinicalTrials.gov Identifier: NCT04367077
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : September 9, 2021
Sponsor:
Information provided by (Responsible Party):
Athersys, Inc

Tracking Information
First Submitted Date  ICMJE April 27, 2020
First Posted Date  ICMJE April 29, 2020
Last Update Posted Date September 9, 2021
Actual Study Start Date  ICMJE April 28, 2020
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
  • All-cause mortality [ Time Frame: Day 60 ]
  • Ranked hierarchical composite outcome of alive and ventilator-free [ Time Frame: Day 28 ]
  • Ventilator-free days [ Time Frame: Day 0 through Day 60 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE ARDS
Intervention  ICMJE
  • Biological: MultiStem
    intravenous infusion
  • Biological: Placebo
    intravenous infusion
Study Arms  ICMJE
  • Experimental: MultiStem
    Intervention: Biological: MultiStem
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2020)		 400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Athersys Clinical Trials Group 2164263597 macovia@athersys.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04367077
Other Study ID Numbers  ICMJE B04-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Athersys, Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Athersys, Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eric Jenkins, MD Athersys, Inc
PRS Account Athersys, Inc
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP