11.11.2020 12:21:18
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Mesoblast: Data Safety Monitoring Board Recommends To Continue Remestemcel-L Trial In COVID-19 ARDS
(RTTNews) - Mesoblast Limited (MESO) said the phase 3 trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome due to COVID-19 infection had received a recommendation to continue from the independent Data Safety Monitoring Board following completion of the trial's second interim analysis. The analysis was performed on the trial's first 135 patients, 45% of the total target of up to 300 randomized patients. The third and final interim analysis, when 60% of the randomized target has completed 30 days of follow-up, will occur in the coming weeks.
The phase 3 trial aims to confirm findings from a pilot study in which nine of 12 ventilator-dependent patients (75%) were successfully discharged from hospital a median of 10 days after receiving two intravenous doses of remestemcel-L within five days.
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