Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Jul;80(7):2031-2042.
doi: 10.1111/all.16515. Epub 2025 Mar 3.

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

M Khaitov  1   2 , A Nikonova  1 , V Smirnov  1   3 , I Shilovsky  1 , I Kofiadi  1 , E Ruzanova  4 , V Teplykh  4 , D Makarov  4 , A Vertichikh  4 , S Teplykh  5 , D Alpenidze  6 , E Muldagalieva  7 , E Simakina  8 , T Ivanushkina  9 , K Zakharov  10 , L Melnikova  11 , D Medvedev  12 , O Zuev  13 , D Kudlay  1   3 , D Kruchko  14 , I Berzin  14 , R Valenta  1   15   16 , V Skvortsova  14
Affiliations
Clinical Trial

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

M Khaitov et al. Allergy. 2025 Jul.

Abstract

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.

Keywords: COVID‐19; SARS‐CoV‐2; clinical trial; efficacy; safety; siRNA.

PubMed Disclaimer

References

    1. M. J. Torres, L. Klimek, I. Agache, et al., “Four Years Into the COVID‐19 Pandemic: Timely Published Articles for Patient Care and EAACI's Leadership Role,” Allergy 79, no. 8 (2024): 2031–2033.
    1. S. Huuskonen, X. Liu, I. Pohner, et al., “The Comprehensive SARS‐CoV‐2 ‘Hijackome’ Knowledge Base,” Cell Discovery 10, no. 1 (2024): 125.
    1. N. Wolter, W. Jassat, S. Walaza, et al., “Early Assessment of the Clinical Severity of the SARS‐CoV‐2 Omicron Variant in South Africa: A Data Linkage Study,” Lancet 399, no. 10323 (2022): 437–446.
    1. C. Menni, A. M. Valdes, L. Polidori, et al., “Symptom Prevalence, Duration, and Risk of Hospital Admission in Individuals Infected With SARS‐CoV‐2 During Periods of Omicron and Delta Variant Dominance: A Prospective Observational Study From the ZOE COVID Study,” Lancet 399, no. 10335 (2022): 1618–1624.
    1. A. Rossler, L. Riepler, D. Bante, D. von Laer, and J. Kimpel, “SARS‐CoV‐2 Omicron Variant Neutralization in Serum From Vaccinated and Convalescent Persons,” New England Journal of Medicine 386, no. 7 (2022): 698–700.

Publication types

LinkOut - more resources