Abstract
Objective: Several investigational monoclonal antibody (mAb) therapies have Emergency Use Authorizations (EUA) for the treatment of mild to moderate coronavirus disease 2019 (COVID-19). In well-designed randomized clinical trials (RCTs), mAb therapies have demonstrated a reduction in the progression to hospitalization and death in high-risk individuals. This study assessed the real-world efficacy of treatment with mAb therapy during a time with a high percentage of the Alpha variant circulating.
Methods: We performed a prospective study looking at the progression to hospitalization in a high-risk treatment population that qualified for mAb therapy under the current EUA and that consented to have their viral isolates undergo whole genome sequencing (WGS) to assess for the presence of genetic variants. A total of 125 patients consented to participate and ultimately 81 participants that both had obtainable sequence data and completed follow-up were included in the final analysis. Based on the risk profile of these participants we anticipated a >10% hospitalization without therapy and a 70-80% reduction based on prior RCTs. Five of the 81 patients (6%) were hospitalized despite monoclonal antibody therapy. The most common variant was Alpha (n=66, 81%), followed by other unknown variants (n=6, 7%), Iota (n=3, 4%), Epsilon (n=2, 2%), Gamma (n=2, 2%), and no variant detected (n=2, 2%).
Conclusion: Monitoring of the local variants, proper procurement decisions regarding specific mAb treatment effective against circulating variants and following real world efficacy has the potential to positively impact the use of mAb therapies. Future studies are needed to assess the efficacy of different mAb treatment results in real world settings with various SARS-CoV-2 variants, various treatment delays and various populations.