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MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)

A

Athersys

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

ARDS

Treatments

Biological: Placebo
Biological: MultiStem

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

400 participants in 2 patient groups, including a placebo group

MultiStem
Experimental group
Treatment:
Biological: MultiStem
Placebo
Placebo Comparator group
Treatment:
Biological: Placebo

Trial contacts and locations

4

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Central trial contact

Athersys Clinical Trials Group

Data sourced from clinicaltrials.gov

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