Clinical Pharmacology Approaches to Predict Efficacy of Monoclonal Antibodies Against Emerging SARS-CoV-2 Variants.

ABSTRACT: The onset of the global COVID-19 pandemic created an urgent need for therapeutic monoclonal antibody (mAb) development, while the rapid mutation of the SARS-CoV-2 virus and emergence of new variants presented a moving target for validation of efficacy. Since it is virtually impossible to conduct randomized controlled trials in the context of a continually evolving variant landscape, other sources of data can inform ongoing effectiveness and appropriate dosing of existing treatments against new variants. This may include data from in vitro neutralization testing, real-world studies, and clinical pharmacology studies. There are various clinical pharmacology approaches available to aid in dose selection of COVID-19 mAbs, and the approach used for initial dose selection may differ from that us

SUBMITTER: Wang Q 

PROVIDER: S-EPMC12649055 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature