On Nov. 11, 2020, Mesoblast announced that the randomized controlled Phase 3 trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection had received a recommendation to continue from the independent Data Safety Monitoring Board (DSMB) following completion of the trialﾒs second interim analysis.

The analysis was performed on the trialﾒs first 135 patients, 45% of the total target of up to 300 randomized patients, with the DSMB recommending continuation after reviewing the trialﾒs primary endpoint, all-cause mortality within 30 days of randomization and all safety data.