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Wednesday, August 26, 2020

CytoDyn enrolls leronlimab study for COVID-19; results expected by mid-October

CytoDyn (OTCQB:CYDY) has reached the requisite number of enrolled patients in its Phase 3 trial of leronlimab in COVID-19 patients with severe-to-critical symptoms to perform an interim analysis following the 28-day phase of the trial, with results anticipated by mid-October. 

The study has three phases lasting 28 days: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured is all-cause mortality at Day 28.
Secondary outcomes measured are all-cause mortality at Day 14, change in clinical status of subject at Day 14 and Day 28, and change from baseline in Sequential Organ Failure Assessment score at Day 14.
Recently, the Data Safety Monitoring Committee completed its first safety review of patients from 149 of 169 patients enrolled and did not raise any concerns regarding safety, thereby recommending the trial to continue as planned.
https://seekingalpha.com/news/3608809-cytodyn-completes-enrollment-in-leronlimab-study-for-covidminus-19-results-expected-mid

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