MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)

Phase 2

• Conditions: ARDS
• Interventions: Biological: MultiStem; Biological: Placebo

• Registration Number: NCT04367077
• Lead Sponsor: Healios K.K.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study Start: 2020-04-28
• Study First Posted: 2020-04-29
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-09
• Primary Completion: 2023-01
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MultiStem	MultiStem	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Ventilator-Free Days	Day 0 through Day 28.
Safety and Tolerability as measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0.	Day 28

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	Day 60
Ranked hierarchical composite outcome of alive and ventilator-free	Day 28
Ventilator-free days	Day 0 through Day 60

Trial Locations

Locations (4)

Athersys Investigational Site 107; 🇺🇸 Chicago, Illinois, United States

Athersys Investigational Site 103; 🇺🇸 Akron, Ohio, United States

Athersys Investigational Site 101; 🇺🇸 Cleveland, Ohio, United States

Athersys Investigational Site 102; 🇺🇸 Cleveland, Ohio, United States