Kinetics of viral load
VIRUS, ORF
Overall, data of the primary outcome did not show a normal distribution (Shapiro–Wilk test, The median/mean viral load value (ORF 1a/b gene) of the ITT analysis set at enrolment was logAs expected, a continuous decrease in the mean virus load was observed in all study groups during the 11 treatment days. The reduction of virus load (reflected by decreases of ORF 1a/b gene copy numbers) from baseline to the end of treatment (day 11) was logAbsolute changes in viral copy numbers (logWithin the subgroup of patients with baseline Ct values below 25, a similar progression of viral load data was observed (Fig. Absolute changes in viral copy numbers (logEvaluation of AUC values (reflecting baseline adjusted decreases of viral load over 11 days) showed that the 0.1% azelastine group exhibited a greater AUC value of 24.14 ± 13.12 (referring to greater decrease) compared to the placebo group with an AUC value of 18.89 ± 4.70 (Area under the curve (AUC) reflecting changes in viral copy numbers (logDecreases of viral load were also reflected in increases of negative PCR results over time. While PCR results in the placebo group turned negative only on day 11 of treatment, individual patients of the 0.1% azelastine group already showed negative PCR test results from day 2 on. On Day 8, 5 of the 27 (18.5%) and 6 of the 28 (21.4%) patients in the 0.1% azelastine and 0.02% azelastine groups, respectively were negative for the ORF1a/b gene, compared to the 0 of 26 patients in the placebo group. At the end of the treatment, 48.2% of the patients of the 0.1% azelastine group showed no detection of the ORF 1a/b gene, whereas only 23.1% of patients of the placebo group showed negative PCR results (supplementary Table Kaplan–Meier survival analyses underlined those findings, indicating that mean times of a PCR result to turn negative was 9.96 days (95% CI: 9.02–10.90) in the 0.1% azelastine group, 10.21 days (95% CI: 9.57–10.86) in the 0.02% azelastine group and 11.00 (95% CI: 10.00–10.77) in the placebo group (Fig. Kaplan–Meier analysis results regarding the ORF 1a/b gene from baseline (day 1) until day 11 of treatment (ITT analysis set).