PRO measurements
fatigue, throat, cough, gastrointestinal, body/systemic, and sense., taste and smell assessments, loss of smell or taste
DISEASE
Questionnaires were administered using an electronic device where possible. A paper PRO option was used in instances where logistical or technical difficulties in using electronic PROs were experienced. FLU-PRO Plus was completed once-daily with a 24-h recall, from Day 1 through Day 21, and then at Day 29, Week 8, and Week 12. Data through Day 29 are reported in this manuscript.COVID-19 symptoms were assessed across the 32 FLU-PRO Plus items and predominantly scored on a five-point severity scale (higher scores indicating more severe symptoms). Severity and duration of symptoms were quantified using the averaged change from baseline in FLU-PRO Plus score (as measured by area under the curve [AUC]) through Day 7, and through Day 14 and Day 21. FLU-PRO Plus total score did not include taste and smell assessments (i.e., sense domain) and these were instead accounted for as a separate binary score; individual domains were nose, throat, eyes, chest/respiratory, gastrointestinal, body/systemic, and sense.Subgroup analyses by symptom severity at baseline were performed for the FLU-PRO Plus endpoints among patients with ≥ 2 symptoms of moderate/higher intensity and those with < 2 symptoms of moderate/higher intensity.Time to sustained (≥ 48 h) symptom alleviation (i.e., responder definition), was measured by the FLU-PRO Plus over the first 21 days. Sustained (≥ 48 h) symptom resolution was defined as the absence of the majority of core symptoms of COVID-19 except for cough and fatigue items scoring no more than “Somewhat” in severity, but loss of smell or taste allowed; this definition was developed in line with the U.S. Food and Drug Administration (FDA) draft guidance [Health-related quality of life was measured by the SF-12 Hybrid, an established measure of health-related quality of life which has demonstrated validity in many disease areas [