EBS - Late-stage study of Emergent Bio's COVID-19 plasma-derived therapy launched

Emergent BioSolutions (EBS) announces the initiation of an NIAID-sponsored Phase 3 clinical trial, INSIGHT-013, evaluating COVID-HIG (one of four such products), a hyperimmune immunoglobulin derived from plasma of people who have recovered from COVID-19, in hospitalized patients infected with the coronavirus.The 500-subject study will compare the plasma-derived therapies plus standard-of-care ((SOC)) treatment compared to placebo + SOC. All participants with receive background therapy of Gilead Sciences' (GILD) Veklury (remdesivir).The primary endpoint is a comparison of clinical status in each group at day 7 of follow-up.Secondary endpoints include all-cause mortality at day 28, discharge status at three time points (day 7, 14, 28) and time to recovery at same three time points.The estimated completion date is July 2021.

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Late-stage study of Emergent Bio's COVID-19 plasma-derived therapy launched