MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)

Status unconfirmed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: ARDS

In brief

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.

Key facts

Study ID

NCT04367077

Run by

Healios K.K.

People needed

400

Starts

2020-04-28

Expected to finish

2023-12-01

Last updated by the study team

2021-09-09

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Athersys Investigational Site 107 — Chicago, Illinois, United States (enrolling)
• Athersys Investigational Site 103 — Akron, Ohio, United States (enrolling)
• Athersys Investigational Site 101 — Cleveland, Ohio, United States (enrolling)
• Athersys Investigational Site 102 — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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