Change in total and individual domain FLU-PRO symptom prevalence and scores
(A) FLU-PRO and COVID-19-specific symptom prevalence. The prevalence of FLU-PRO and COVID-19-specific (loss of taste, loss of smell) symptoms at baseline and follow-up distributed by total and individual domains. A significant reduction in the total (p = 0.005) and body/systemic (p = 0.006) domains occurred between groups. A numerically larger reduction in chest/respiratory symptoms occurred in the IPE (69%) compared with the usual care cohort (53%), although not a significant difference. The remaining domains had similar reductions in prevalence between groups. Values shown are based on the number of patients with complete paired data and non-zero treatment compliance. All domains within the IPE and usual care cohorts had significant within-group differences, comparing the number of symptomatic patients at baseline versus follow-up, via Chi-square analyses: IPE (p < 0.01 within all domains except the gastrointestinal domain [p = 0.049]); usual care (p ≤ 0.01 within all domains).
(B) Prespecified primary clinical endpoint - change in FLU-PRO scores. Mean change in FLU-PRO scores from baseline to follow-up, distributed by total and individual domains. A significant score reduction in the IPE group compared with the usual care cohort occurred in the total (p = 0.003), body/systemic (p = 0.001), and chest/respiratory (p = 0.01) domains. A significant score reduction in the usual care group compared with the IPE cohort occurred in the gastrointestinal domain (p = 0.026). The remaining domains had non-significant changes in scores between groups. Values shown are based on the number of patients with complete paired data and non-zero treatment compliance. Mean FLU-PRO scores and associated between-group p values at baseline, per domain: Total: IPE = 0.18, usual care = 0.14, p = 0.03; body/systemic: IPE = 0.28, usual care = 0.23, p = 0.04; gastrointestinal: IPE = 0.01, usual care = 0.04, p = 0.04; chest/respiratory: IPE = 0.25, usual care = 0.16, p = 0.03; eyes: IPE = 0.02, usual care = 0.01, p = 0.34; throat; IPE = 0.10, usual care = 0.08, p = 0.59; nose: IPE = 0.10, usual care = 0.05, p = 0.16.