2.4. Statistical Analysis
ADVERSE EVENTS, VIRUS, EMERGENCY, SECONDARY
The primary endpoints of the study were: (1) time to virus RNA clearance as measured by quantitative RT-PCR analysis of nasopharyngeal swabs using a validated, laboratory-developed test based on the U.S. CDC 2019-nCoV Emergency Use Authorization assay, and (2) the proportion of patients with symptoms resolution at day 5 from baseline. Secondary endpoints evaluated the antiviral activity, symptom resolution, changes in the WHO clinical progression scale, and emergence of adverse events at each of the clinic visits along with the pharmacokinetics of probenecid.Time to virus RNA clearance was estimated using the Kaplan–Meier (KM) method. The median time to virus RNA clearance along with the 95% confidence intervals is given for each treatment arm. The number and percentage of subjects with time to virus RNA clearance and who are censored are presented, as are the KM product-limit estimates of the 25th, 50th (median), and 75th percentiles with associated CIs (where estimable). Viral loads below the limit of detection of 250 copies/mL were imputed as 125 copies/mL.The proportion of patients with symptom resolution at days 3, 5, 10, and 15 was assessed using chi-square statistics. The chi-square test was used for the comparison of proportions from all treatment groups. In addition to a The change in the WHO progressions scale at days 3, 5, 10, 15, and 28 was analyzed using ANCOVA. ANCOVA analysis was performed for change from baseline analysis. ANCOVA model with change from baseline as the response variable and the baseline value of respective parameter and treatment as independent variables was fit to test mean difference between the treatments in change from baseline. Adjusted least square (LS) mean and the standard error values along with the In the absence of previous efficacy data for probenecid, a sample size of 75 patients (25 patients/treatment regimen) was used.A complete listing of all secondary endpoints is included in the protocol, available from the corresponding author.