MultiStem Administration for COVID-19 Induced ARDS (MACoVIA) | NCT04367077

Studies
MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)

NCT04367077

Sponsor

Healios K.K.

Status

Unknown status

Last Update Posted

Sep 9, 2021Actual

Enrollment

400Estimated

Phase

Phase 2Phase 3

Conditions

ARDS

Interventions

MultiStem
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 28, 2020Actual

Primary Completion Date

Jan 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Apr 27, 2020

First Submission Date that Met QC Criteria

Apr 27, 2020

First Posted Date

Apr 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2021

Last Update Posted Date

Sep 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MultiStem	Experimental		Biological: MultiStem
Placebo	Placebo Comparator		Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MultiStem	Biological	intravenous infusion	MultiStem
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
All-cause mortality		Day 60
Ranked hierarchical composite outcome of alive and ventilator-free		Day 28
Ventilator-free days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Athersys Clinical Trials Group	Contact	2164263597		macovia@athersys.com

Overall Officials

Name	Affiliation	Role
Eric Jenkins, MD	Healios K.K.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Athersys Investigational Site 107	Recruiting	Chicago	Illinois	60601	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D004417	Dyspnea

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided