MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)

Healios

Status and phase: Unknown; Phase 3; Phase 2

Conditions: ARDS

Treatments: Biological: MultiStem; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04367077

B04-03

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

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400 participants in 2 patient groups, including a placebo group

MultiStem

Experimental group

Treatment:

Biological: MultiStem

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo