Reduces risk for hospitalizations and/or deaths for nonhospitalized patients at high risk for clinical progression
By Elana Gotkine HealthDay Reporter
WEDNESDAY, April 19, 2023 (HealthDay News) — For nonhospitalized patients with COVID-19 at high risk for clinical progression, amubarvimab plus romlusevimab is safe and reduces the risk for hospitalization and/or death, according to a study published online April 18 in the Annals of Internal Medicine.
Teresa H. Evering, M.D., from Weill Cornell Medicine in New York City, and colleagues examined the safety and efficacy of amubarvimab plus romlusevimab in a randomized phase 2 and 3 platform trial among nonhospitalized patients with COVID-19. The phase 3 analysis included 807 participants within 10 days of symptom onset at high risk for clinical progression, with a median age of 49 years.
The researchers found that hospitalizations and/or death occurred in 2.3 and 10.7 percent of participants in the amubarvimab plus romlusevimab and placebo groups, respectively, with an estimated reduction in events of 79 percent. Those with five or less and more than five days of symptoms at study entry had similar reductions. Participants randomly assigned to amubarvimab plus romlusevimab less frequently had grade 3 or higher treatment-emergent adverse events through day 28 than those randomly assigned to placebo (7.3 versus 16.1 percent); there were no severe infusion reactions or drug-related serious adverse events reported.
“Amubarvimab plus romlusevimab is safe and effective in reducing hospitalizations and deaths among those with mild-to-moderate COVID-19 at high risk for clinical progression and acquired infection before emergence of omicron variants,” the authors write.
Several authors disclosed financial ties to the pharmaceutical and biomedical industries.
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