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Updated: May 24, 2025
Live Imaging and Quantification of Viral Infection in K18 hACE2 Transgenic Mice Using Reporter-Expressing Recombinant SARS-CoV-2
Published on: November 5, 2021
Phase 2-3 Trial: Prevention of the Progression to Moderate and Severe COVID-19 in SARS-CoV-2-Infected
M Khaitov1,2, A Nikonova1, V Smirnov1,3
1National Research Center (NRC) Institute of Immunology Federal Medical-Biological Agency (FMBA) of Russia, Moscow, Russia.
Background:
COVID-19 continues to be a major global health challenge. Inhaled siRNA-based MIR 19 has been shown to reduce the time to clinical improvement in patients hospitalized with moderate COVID-19.
Methods:
We conducted an open-label, randomized, controlled multicenter phase 2b-3 trial (NCT05783206) evaluating the safety and efficacy of inhaled siR-7-EM/KK-46 (MIR 19) (5.55 mg/day) in comparison with standard care (control group) in outpatients with mild COVID-19 (N = 492 for each group). The primary endpoint was the proportion of patients who developed moderate or severe COVID-19 by the 28th day of randomization.
Results:
Moderate or severe course of the disease was detected in 14 (2.85%) and 34 (6.91%) patients in the siR-7-EM/KK-46 (5.55 mg) and standard therapy groups, respectively (the difference in proportions was -4.107% [95% CI: -7.28% to -1.03%] (p = 0.002)). Adverse events (AE) were reported in 77 (15.65%) patients from the siR-7-EM/KK-46 (5.55 mg) group, while in the standard therapy group AEs were registered in 100 (20.33%) patients. No severe, treatment-related AEs were observed in the siR-7-EM/KK-46 group.
Conclusions:
siR-7-EM/KK-46, a SARS-CoV-2-specific RNAi-based drug, was well-tolerated and significantly decreased the progression to moderate/severe disease in outpatients with mild COVID-19.
