Aim:
Sotrovimab is an engineered human
monoclonal antibody that binds a conserved region of the
SARS-CoV-2 spike protein. The COMET-
ICE phase III study evaluated
sotrovimab for treatment of mild to moderate
COVID-19 in nonhospitalized participants with ≥1 risk factor for severe
disease progression. Materials & methods: We evaluated the presence of circulating SARS-CoV-2 variants of concern or interest (VOCs/VOIs) and characterized the presence of baseline, post-baseline and emergent amino acid substitutions detected in the
epitope of
sotrovimab in SARS-CoV-2. Results: None of the
sotrovimab-treated participants with baseline
epitope substitutions, and 1 of 48
sotrovimab-treated participants with post-baseline
epitope substitutions, met the primary clinical endpoint for progression. Conclusion: Overall, progression was not associated with identified VOC/VOI or the presence of
epitope substitutions in
sotrovimab-treated participants.