MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)

ARDS Clinical Trial

— MACoVIA  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04367077
• Other study ID #: B04-03
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 28, 2020
• Est. completion date: December 2023

Study information

• Verified date: September 2021
• Source: Athersys, Inc
• Contact: Athersys Clinical Trials Group
• Phone: 2164263597
• Email: macovia[@]athersys.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• ARDS

Intervention

Biological:
• MultiStem
intravenous infusion
• Placebo
intravenous infusion

Locations

Country	Name	City	State
United States	Athersys Investigational Site 103	Akron	Ohio
United States	Athersys Investigational Site 107	Chicago	Illinois
United States	Athersys Investigational Site 101	Cleveland	Ohio
United States	Athersys Investigational Site 102	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Athersys, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator-Free Days		Day 0 through Day 28.
Primary	Safety and Tolerability as measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0.		Day 28
Secondary	All-cause mortality		Day 60
Secondary	Ranked hierarchical composite outcome of alive and ventilator-free		Day 28
Secondary	Ventilator-free days		Day 0 through Day 60