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

September 7, 2021 updated by: Athersys, Inc

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)

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60601
        • Recruiting
        • Athersys Investigational Site 107
        • Contact:
    • Ohio
      • Akron, Ohio, United States, 44304
        • Recruiting
        • Athersys Investigational Site 103
        • Contact:
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Athersys Investigational Site 101
        • Contact:
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • Athersys Investigational Site 102
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: Placebo
intravenous infusion
Experimental: MultiStem
Biological: MultiStem
intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ventilator-Free Days
Time Frame: Day 0 through Day 28.
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
Day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: Day 60
Day 60
Ranked hierarchical composite outcome of alive and ventilator-free
Time Frame: Day 28
Day 28
Ventilator-free days
Time Frame: Day 0 through Day 60
Day 0 through Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Athersys, Inc

Investigators

  • Study Director: Eric Jenkins, MD, Athersys, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2020

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B04-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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