MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)

NCT ID: NCT04367077

Last Updated: 2021-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-28

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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ARDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MultiStem

Group Type EXPERIMENTAL

MultiStem

Intervention Type BIOLOGICAL

intravenous infusion

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

intravenous infusion

Interventions

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MultiStem

intravenous infusion

Intervention Type BIOLOGICAL

Placebo

intravenous infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Healios K.K.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Jenkins, MD

Role: STUDY_DIRECTOR

Healios K.K.

Locations

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Athersys Investigational Site 107

Chicago, Illinois, United States

Site Status RECRUITING

Athersys Investigational Site 103

Akron, Ohio, United States

Site Status RECRUITING

Athersys Investigational Site 101

Cleveland, Ohio, United States

Site Status RECRUITING

Athersys Investigational Site 102

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Athersys Clinical Trials Group

Role: CONTACT

2164263597

Facility Contacts

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Athersys Clinical Trials Group

Role: primary

216-426-3597

Athersys Clinical Trials Group

Role: primary

216-426-3597

Athersys Clinical Trials Group

Role: primary

216-426-3597

Athersys Clinical Trials Group

Role: primary

216-426-3597

Other Identifiers

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B04-03

Identifier Type: -

Identifier Source: org_study_id

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