Statistical analysis
anosmia, death, ageusia, fever
EVENTS, RECRUITMENT, DISEASES, VIRAL SHEDDING
Assuming that the median time to sustained improvement or resolution was 12 days in control group and 9 days in LHQW group, 652 patients would be randomized to LHQW or placebo group (1:1) with a 95% power with a two-sided significance of 0.05 according to PASS software. In practice, patients were enrolled while taking into account RAT findings, and 344 patients per group would be needed when assuming that 95% of patients with positive RAT findings would yield positive NAAT findings. Recruitment of 860 patients would be needed while considering a 20% dropout rate.We conducted statistical analyses with SAS 9.4 software (SAS Institute, Cary, North Carolina). All patients who had been randomized and taken at least one dose of study medication and had a confirmed diagnosis of COVID-19 based on NAAT were included in the full-analysis set. Patients who fully complied with the protocol (adherence: 80% or greater) were included in per-protocol set. We prioritized data presentation of the full-analysis set. The primary endpoint was analyzed by using the Log-rank test and displayed with Kaplan-Meier curve. The time to events was presented as the median duration and 95% confidence interval (95%CI). The hazards ratio (HR) of clinical events was demonstrated. We analyzed the following endpoints with chi-square test or Fisher’s exact probability model, including the proportion of patients with alleviation of symptoms, reduction in viral shedding (censored at day 14), major improvement in radiology, severe and critical diseases, death and all-cause death. We also analyzed the median time to sustained alleviation of single symptom, the alleviation of fever, digestive symptoms, ageusia or anosmia and all clinical symptoms, and the duration of viral shedding with the same analytical strategy with the primary endpoint. We conducted The FLOSAN trial was registered with Chinese Clinical Trial Registry (No.: ChiCTR2200056727). The CONSORT checklist can be found in the supplemental file.