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Trial record 1 of 1 for:    NCT04367077
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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
ARDS Biological: MultiStem Biological: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MultiStem Biological: MultiStem
intravenous infusion
Placebo Comparator: Placebo Biological: Placebo
intravenous infusion


Outcome Measures
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Primary Outcome Measures :
  1. Ventilator-Free Days [ Time Frame: Day 0 through Day 28. ]
  2. 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 Measures :
  1. All-cause mortality [ Time Frame: Day 60 ]
  2. Ranked hierarchical composite outcome of alive and ventilator-free [ Time Frame: Day 28 ]
  3. Ventilator-free days [ Time Frame: Day 0 through Day 60 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04367077


Contacts
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Contact: Athersys Clinical Trials Group 2164263597 macovia@athersys.com

Locations
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United States, Illinois
Athersys Investigational Site 107 Recruiting
Chicago, Illinois, United States, 60601
Contact: Athersys Clinical Trials Group    216-426-3597    macovia@athersys.com   
United States, Ohio
Athersys Investigational Site 103 Recruiting
Akron, Ohio, United States, 44304
Contact: Athersys Clinical Trials Group    216-426-3597    macovia@athersys.com   
Athersys Investigational Site 101 Recruiting
Cleveland, Ohio, United States, 44106
Contact: Athersys Clinical Trials Group    216-426-3597    macovia@athersys.com   
Athersys Investigational Site 102 Recruiting
Cleveland, Ohio, United States, 44109
Contact: Athersys Clinical Trials Group    216-426-3597    macovia@athersys.com   
Sponsors and Collaborators
Athersys, Inc
Investigators
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Study Director: Eric Jenkins, MD Athersys, Inc
More Information
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Responsible Party: Athersys, Inc
ClinicalTrials.gov Identifier: NCT04367077    
Other Study ID Numbers: B04-03
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Athersys, Inc:
COVID19
respiratory distress
adult stem cells
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases