MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)

• Sponsor: Athersys, Inc (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04367077
• Collaborator: (none)
• Enrollment: 400
• Locations: 4
• Arms: 2
• Anticipated Duration (Months): 43.1
• Patients Per Site: 100
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ARDS	Biological: MultiStem; Biological: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Apr 28, 2020
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Ventilator-Free Days [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. [Day 28]

Secondary Outcome Measures

1. All-cause mortality [Day 60]

2. Ranked hierarchical composite outcome of alive and ventilator-free [Day 28]

3. Ventilator-free days [Day 0 through Day 60]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Athersys Investigational Site 107	Chicago	Illinois	United States	60601
2	Athersys Investigational Site 103	Akron	Ohio	United States	44304
3	Athersys Investigational Site 101	Cleveland	Ohio	United States	44106
4	Athersys Investigational Site 102	Cleveland	Ohio	United States	44109

Sponsors and Collaborators

• Athersys, Inc

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Athersys, Inc
• ClinicalTrials.gov Identifier: NCT04367077
• Other Study ID Numbers: B04-03
• First Posted: Apr 29, 2020
• Last Update Posted: Sep 9, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Athersys, Inc: COVID19; respiratory distress; adult stem cells
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Sep 9, 2021