Abstract
INTRODUCTION: Bamlanivimab and etesevimab (BAM + ETE) are monoclonal antibodies (mAbs) effective in reducing COVID-19-related hospitalizations and all-cause mortality in adult participants at increased risk for severe disease. We present pharmacokinetic (PK), efficacy, and safety results from pediatric participants (< 18 years of age) with covid-19 who were treated with bam + ete. methods: in an addendum to the phase 2 3 blaze-1 clinical trial (nct04427501), pediatric participants received open-label weight-based dosing (wbd, n =" 94)" based on exposure-matching to the authorized dose of bam + ete in adult participants. for efficacy and safety assessments, placebo (n =" 14)" and bam + ete (n =" 20)-treated" adolescent participants (> 12 to < 18 years of age) from the blaze-1 trial were included in the overall pediatric population (n =" 128)." all participants had mild to moderate covid-19 upon enrollment and ≥ 1 risk factor for severe covid-19. the primary objective was to characterize the pk of bam and ete in the wbd population. results: the median age of the participants was 11.2 years, 46.1% were female, 57.9% were black african american, and 19.7% were hispanic latino. the area under the curve for bam and ete in the wbd population was similar to that previously observed in adults. there were no covid-19-related hospitalizations or deaths. all adverse events (ae) except one were mild or moderate, with one participant reporting a serious ae. conclusion: wbd in pediatric participants achieved similar drug exposures compared to adult participants that received the authorized bam + ete dose. the pediatric efficacy and safety data were consistent with adults receiving mabs for covid-19. trial registration number: nct04427501.>
