Remarks

• Whereas sotrovimab achieves a substantial reduction in the relative risk of hospitalization, the absolute benefit will be trivial in absolute terms except in those at highest risk for hospitalization, for which the intervention should be reserved.
• The panel identified a risk beyond 10% of being hospitalized for COVID-19 to represent a threshold at which most people would want to be treated with sotrovimab.
• In the absence of credible tools to predict risk for hospitalization in people infected with COVID-19, typical characteristics of people at highest risk include those who are unvaccinated, older people, or those with immunodeficiencies and/or chronic diseases (e.g. diabetes).
• Casirivimab-imdevimab were also conditionally recommended (see Section 6.5) and represent an alternative to sotrovimab; the two drugs should not be given together. The choice of which monoclonal antibodies to use depends on availability, as well as clinical and contextual factors, including emerging information about effectiveness with different variants (see Justification).
• Patients with severe or critical COVID-19: based on current evidence, the benefit of sotrovimab in seronegative patients with severe or critical COVID-19 (see casirivimab-imdevimab recommendation in Section 6.5) remains unclear. This means that careful clinical judgment needs to be applied if casirivimab-imdevimab is unavailable and sotrovimab is considered. New trial evidence for sotrovimab in this setting was published after the GDG developed recommendations for this iteration, and will be considered, alongside other publicly available emerging evidence, when developing future recommendations.

Practical Info Route, dosage and duration: Additional considerations are available in a summary of practical issues. Here follows a brief summary of key points.

• The authorized dose for sotrovimab is one single intravenous infusion of 500 mg over 30 minutes, administered as soon as possible after a positive viral test for SARS-CoV-2 and within 10 days of symptom onset.
• Sotrovimab is available as a concentrated solution, and must be diluted prior to administration.
• Patients should be clinically monitored patients during the infusion, and observed for at least 1 hour after the infusion is completed