This recommendation was based on a low likelihood that the intervention would be of clinical value in this hospitalized patient population. 26, 2020 and recommended no further participants be randomized to receive LY-CoV555 and that the investigators be unblinded to the data. The DSMB reviewed data from the ACTIV-3 trial on Oct. Subsequently, it was developed and manufactured by Indianapolis-based Lilly Research Laboratories, Eli Lilly and Company, in partnership with AbCellera. The monoclonal antibody was discovered by AbCellera Biologics based in Vancouver, in collaboration with NIAID’s Vaccine Research Center. The first agent evaluated in the Phase 3, randomized, controlled trial was LY-CoV555. If the investigational agent appears to be safe and effective based on an evaluation of the first 300 participants (stage 1), an additional 700 participants are randomized and followed for 90 days to assess sustained recovery, defined as being discharged, alive and home for 14 days (stage 2). After five days, participants’ clinical status is assessed based on an ordinal scale. All participants also receive standard care for patients hospitalized with COVID-19, including the antiviral remdesivir. Participants in the trial are randomly assigned to receive either an experimental agent or a matched placebo. The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.ĪCTIV-3 is a master protocol designed to allow for the study of multiple investigational agents compared to placebo in adults hospitalized with COVID-19. The ACTIV-3 clinical trial evaluating the investigational monoclonal antibody LY-CoV555 in hospitalized patients with COVID-19 will not enroll more participants into this sub-study following a recommendation from the independent Data and Safety Monitoring Board (DSMB).
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