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Vir Biotechnology and GSK provide update on NIH-sponsored ACTIV-3 trial evaluating VIR 7831 in hospitalised adults with COVID-19.

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Published:5th Mar 2021
Vir Biotechnology, Inc. and GlaxoSmithKline plc provided an update on the VIR 7831 (GSK4182136) arm of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase III clinical trial. The companies were informed that while VIR 7831 met initial pre-specified criteria to continue to the next phase of the ACTIV-3 trial and there were no reported safety signals, sensitivity analyses of the available data raised concerns about the magnitude of potential benefit. The independent Data and Safety Monitoring Board (DSMB) has recommended that the VIR 7831 arm of the trial be closed to enrolment while the data mature . The companies will continue discussions with the NIH about appropriate ways to further assess the potential of VIR 7831 in the hospitalised population as all parties gain a fuller understanding of the still-emerging data. The DSMB recommendation was based on a routine, pre-planned safety and efficacy data review of the first 300 patients hospitalised with COVID-19 enrolled in ACTIV-3.
Condition: Coronavirus/COVID-19 Infection
Type: drug

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