Fig. 1: Safety and efficacy of inhaled bispecific single-domain antibody BM219 for mild-to-moderate COVID-19.

a Trial profile. Patients with mild-to-moderate COVID-19 were recruited to assess the efficacy of inhaled BM219. A total of 84 participants were randomized into three cohorts to receive BM219 at 60 mg twice daily, 120 mg once daily, 120 mg twice daily. Within each cohort, participants were further assigned to receive either BM219 or a matching placebo at a 5:2 ratio over a 5-day treatment period. b Adverse events occurring from the first dose through 28 days. Bar graphs present the percentage of participants reporting adverse events (AEs), serious AEs (SAEs), grade ≥ 3 AEs, and events leading to trial interruption, stratified by treatment group (60 mg BID, 120 mg QD, 120 mg BID, and placebo). Denominators indicate group sample sizes (n = 20 or n = 24). AE categories are defined in protocol. c Change in viral load from baseline through day 5 in the JN.1-infected patients over time. The viral load was quantified by RT-PCR of nasopharyngeal swabs, with Day 1 (pre-first dose) defined as baseline. Shown are the mean absolute changes in viral load (log10 copies/mL) from baseline through Day 5 for each treatment group (60 mg BID, 120 mg QD, 120 mg BID) and the corresponding placebo group among JN.1-infected participants. d Time to sustained clinical recovery in the full analysis population. Final analysis was performed using the Kaplan–Meier method. Shown is the cumulative incidence of time to sustained clinical recovery (hours) for placebo, 60 mg BID, 120 mg QD, and 120 mg BID groups. Sustained clinical recovery was defined as the alleviation of all COVID-19-related symptoms to a total score of 0 or 1 (sum of 11 symptoms, each scored 0–3; total range 0–33) maintained for at least 2 consecutive days. Data include number of participants at risk at each timepoint, event rates (n, %), median times with 95% confidence intervals (95% CI), and comparative treatment trajectories.