
2.6. Outcome measures and endpoints
sore throat, smell or taste disorder, tiredness, cough
SORE THROAT, SECONDARY, RECURRENCE, SARS-COV-2 INFECTION
The primary endpoint for this study will be the time to resolution of the 5 COVID-19 symptoms, defined as the time from the start of the study intervention until the resolution of the 5 symptoms (stuffy or runny nose, sore throat, cough, feeling hot or feverish, and low energy or tiredness) of SARS-CoV-2 infection. Patients will assess their symptoms using a partially modified index prescribed by the Food and Drug Administration (FDA)The 2 key secondary endpoints for this study will be change from baseline on Day 4 in the amount of SARS-CoV-2 viral RNA (key secondary endpoint 1) and the time to first negative SARS-CoV-2 viral titer, defined as the time from the first administration of the study intervention until the first confirmation of SARS-CoV-2 viral titer below a predetermined detection limit (key secondary endpoint 2). To evaluate the antiviral and clinical efficacy more clearly, for the primary and key secondary endpoints, the primary analysis population was defined as patients randomized <72 hours from the onset of COVID-19.Other secondary endpoints will include the time to resolution of the 5 COVID-19 symptoms without symptom recurrence, defined as no increase of any symptom scores to moderate or severe at least for 48 hours after achieving resolution; the time to resolution of the 12 and 14 COVID-19 symptoms; the proportion of patients with smell or taste disorder at each time point; the proportion of patients without resolution of COVID-19 symptoms 3 weeks after the study intervention; change from baseline in SARS-CoV-2 viral titer and viral RNA at each time point; and scores on the 8-point ordinal scale at each time point (Supplemental Table 3, 