On May 6, 2020, Mesoblast announced that the first patients were dosed in the 300-patient randomized placebo-controlled Phase 2/3 trial in the U.S. of Mesoblast’s allogeneic cellular medicine remestemcel-L in COVID-19 infected patients with moderate to severe acute respiratory distress syndrome (ARDS) on ventilator support.

Mesoblast holds an Investigational New Drug (IND) application cleared by the FDA for use of remestemcel-L in the treatment of patients with COVID-19 ARDS. The clinical protocol for the Phase 2/3 trial is based on initial promising results from use of remestemcel-L in patients with moderate to severe COVID-19 ARDS under an emergency IND application or expanded access protocol at The Mount Sinai Hospital in New York. The trial will randomize up to 300 ventilator-dependent patients in intensive care units to either remestemcel-L or placebo (1:1) on top of maximal care, in line with specific guidance provided by the United States Food and Drug Administration (FDA) for robust statistical analysis. The primary endpoint is all-cause mortality within 30 days of randomization, with the key secondary endpoint being the number of days alive and off mechanical support.

The trial will include up to 30 sites across North America, with patient screening and enrollment having already commenced at Baylor University Medical Center, a part of Baylor Scott & White Health; Cleveland Clinic, Duke University Hospital, Keck Medical Center of USC, Lutheran Hospital Indiana, The Mount Sinai Hospital, Ochsner Medical Center – Jefferson Highway, and the University of Maryland School of Medicine/University of Maryland Medical Center. Enrollment is expected to complete within three to four months, with interim analyses planned which could result in stopping the trial early for efficacy or futility.