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The following is a summary of “Phase 2-3 Trial: Prevention of the Progression to Moderate and Severe COVID-19 in SARS-CoV-2-Infected Non-Hospitalized Adults With Inhaled siRNA-Based MIR 19,” published in the March 2025 issue of European Journal of Allergy and Clinical Immunology by Khaitov et al. 

Researchers conducted a retrospective study on inhaled siRNA-based MIR 19, which reduced the time to clinical improvement in hospitalized patients with moderate COVID-19.  

They conducted an open-label, randomized, controlled multicenter phase 2b-3 trial (NCT05783206) to assess the safety and efficacy of inhaled siR-7-EM/KK-46 (MIR 19) (5.55 mg/day) versus standard care in outpatients with mild COVID-19 (N=492 per group). The primary endpoint was the proportion of patients developing moderate or severe COVID-19 by day 28. 

The results showed moderate or severe disease in 14 (2.85%) and 34 (6.91%) patients in the siR-7-EM/KK-46 (5.55 mg) and standard therapy groups, respectively (difference −4.107% [95% CI: −7.28% to −1.03%], P=0.002). Adverse events (AEs) occurred in 77 (15.65%) patients with siR-7-EM/KK-46 and 100 (20.33%) with standard therapy. No severe treatment-related adverse events were observed in the siR-7-EM/KK-46 group. 

Investigators found siR-7-EM/KK-46 well-tolerated and effective in reducing progression to moderate or severe disease in outpatients with mild COVID-19. 

Source: onlinelibrary.wiley.com/doi/abs/10.1111/all.16515