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Terminated

NCT Number: NCT04367077

MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)

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.

Why the study stopped: Sponsor's decision
Terminated

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Key information

Conditions

ARDS COVID-19 Coronaviridae Infections Coronavirus Infections Dyspnea Infections Lung Diseases Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Virus Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Athersys Investigational Site 107, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MultiStem

Biological

intravenous infusion

Placebo

Biological

intravenous infusion

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Healios K.K.

Industry

Registry information

Official study 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)

Acronym: MACoVIA

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2020
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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