Original article: Efficacy and safety of single-dose suraxavir marboxil tablet in the treatment of acute uncomplicated influenza in adults: a multi-center, randomized, double-blind, placebo-controlled phase 2 clinical trial.

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To evaluate the therapeutic effect of suraxavir marboxil (GP681, abbreviated as suraxavir) in adults with uncomplicated influenza. We conducted a multi-center randomized, double-blind, placebo-controlled phase 2 trial in 18 Chinese centers. Participants had to be aged 18-65years with positive influenza test, presenting with at least one influenza systemic and respiratory symptoms in at least moderate severity within 48hours of onset. Participants were randomly assigned in 1:1:1 to receive suraxavir 40 mg, 20 mg or placebo once. The primary outcome was defined as the time to alleviation of influenza symptoms (TTAS) (from treatment to normal body temperature and resolution of all 7 influenza symptoms for ≥21.5hours) within 15days. Our trial was registered at ClinicalTrials.gov (NCT04736758). From January 8, 2021, to December 18, 2021, 245 participants underwent randomization, and 203 (82.9%) were included in the intention-to-treat infected population, with median age of 29.0 (IQR 11.0) years and the most common virus of influenza B (99.5%, 202/203). The median TTAS was shorter in two suraxavir groups (40 mg: 50.0 [44.1, 71.9] hours; 20 mg: 46.1 [39.6, 58.2] hours) than placebo group (82.3 [67.9, 87.3] hours). The mean (±SD) changes in viral titers from baseline in the suraxavir 40mg group, suraxavir 20mg group and placebo group were -2.14±1.97, -1.48±2.01 and -0.69±1.98 log10 50% tissue culture infectious dose/mL by 1day after administration, respectively. The incidences of adverse events were similar in each group (47.2%, 34/72; 46.6%, 34/73; 53.5%,38/71). The most reported adverse event was diarrhea (7.6%, 11/145). Only one serious adverse event of pulmonary infection occurred in the placebo group. No I38T polymerase acidic protein variants were detected. In this trial, timely single-dose suraxavir was effective in improving clinical symptoms and accelerating viral clearance in adults with uncomplicated influenza B infection safely than placebo.