Discussion
infection, illness
INFECTION, DISEASE, INFLUENZA
A previous report from the COMET-ICE study has demonstrated the efficacy of sotrovimab for improving rates of hospitalization and survival in high-risk COVID-19 patients [Based on AUC, sotrovimab provides statistically significant improvements through Day 21 in patient-reported symptoms compared with placebo. Based on the observed mean daily FLU-PRO Plus total and individual domain scores, improvements with sotrovimab occurred rapidly (within a week of treatment administration) compared to placebo, and the observed mean daily score for the individual domains of the FLU-PRO Plus followed a similar pattern. The clinical relevance of the PRO findings was further supported by estimates towards shorter time to symptom resolution in the sotrovimab arm compared to placebo. As COVID-19 vaccination and prior infection become increasingly widespread, further improvements in time to symptom resolution may occur. As seen previously in influenza, duration of illness is shortened among immune participants [Sub-group analyses were generally consistent with results for the overall population, although interpretation of the data for some categories is limited due to the small numbers of participants completing the questionnaires. Results obtained with other PRO tools were less conclusive. Minimal difference between the sotrovimab and placebo arms was observed for any of the WPAI domains, and little difference was observed for any of the SF-12 domains or summary scores. It should be noted that these instruments are generic, and therefore may be less sensitive to change overall in a specific disease.Although the COMET-ICE trial, as well as analyses of the content validity and psychometric properties of the FLU-PRO Plus [The main limitation of the current analysis is the potential for bias due to missing questionnaire data. This was primarily due to operational challenges surrounding rapid initiation of the study which resulted from urgent medical need during the early stages of the pandemic. This led to a lack of time to sufficiently execute electronic PRO set-up and implement a back-up paper plan. However, despite these challenges, completion rates were similar between both treatment arms, with more than 80% of participants completing the questionnaire on Day 1 and approximately 50% at Day 21. In addition, no single minimal clinically important difference for FLU-PRO in COVID-19 has been established, and was not developed as part of this study.