A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2021;9(8):14 N Engl J Med. 2021 Mar 11;384(10): 905-914.What this means for my practice?
The results of this study may suggests that a single intravenous infusion of LY-CoV555 does not provide a clinical benefit for hospitalized patients with COVID-19. This study should be interpreted as part of a preliminary study on LY-CoV555 efficacy. Definitive statements on the safety of LY-CoV555 cannot be made due to the small sample size and shorter-than-planned duration of the study.
Study Summary
Three hundred and fourteen hospitalized patients with COVID-19 were randomized to receive a single intravenous infusion of LY-CoV555 antibody therapy (n=163) or placebo (n=151) for the improvement of recovery and reduction of adverse events. The primary outcomes of interest was sustained recovery (discharged home and remaining at home for at lest 14 days) and a composite safety outcome of death, serious adverse events, and grade 3 or 4 adverse events through day 5. Secondary outcomes of interest included the incidence of hospital discharge, incidence of infusion reaction, the composite safety outcome of organ dysfunction and serious co-infection, mortality, and pulmonary ordinal and pulmonary plus ordinal outcomes (measures of oxygen requirements and organ dysfunction, respectively). Outcomes were assessed for a median of 31 days follow up. Results revealed no statistically significant differences in all outcomes between the two groups (p>0.05 for all).
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