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; A Nikonova; V Smirnov; I Shilovsky; I Kofiadi; E Ruzanova; V Teplykh; D Makarov; A Vertichikh; S Teplykh; D Alpenidze; E Muldagalieva; E Simakina; T Ivanushkina; K Zakharov; L Melnikova; D Medvedev; O Zuev; D Kudlay; D Kruchko; I Berzin; R Valenta; V Skvortsova

doi:10.1111/all.16515

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, A Nikonova, V Smirnov, I Shilovsky, I Kofiadi, E Ruzanova, V Teplykh, D Makarov, A Vertichikh, S Teplykh, D Alpenidze, E Muldagalieva, E Simakina, T Ivanushkina, K Zakharov, L Melnikova, D Medvedev, O Zuev, D Kudlay, D KruchkoI Berzin, R Valenta, V Skvortsova

Scientific Working Group Allergology and Immunology

Research output: Journal article (peer-reviewed) › Journal article

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.

Original language	English
Journal	Allergy: European Journal of Allergy and Clinical Immunology
DOIs	https://doi.org/10.1111/all.16515
Publication status	E-pub ahead of print - 03 Mar 2025

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Khaitov, M., Nikonova, A., Smirnov, V., Shilovsky, I., Kofiadi, I., Ruzanova, E., Teplykh, V., Makarov, D., Vertichikh, A., Teplykh, S., Alpenidze, D., Muldagalieva, E., Simakina, E., Ivanushkina, T., Zakharov, K., Melnikova, L., Medvedev, D., Zuev, O., Kudlay, D., ... Skvortsova, V. (2025). 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. Allergy: European Journal of Allergy and Clinical Immunology. Advance online publication. https://doi.org/10.1111/all.16515

@article{55b5fceb47214e41a7a706700365e4d6,

title = "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",

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.",

author = "M Khaitov and A Nikonova and V Smirnov and I Shilovsky and I Kofiadi and E Ruzanova and V Teplykh and D Makarov and A Vertichikh and S Teplykh and D Alpenidze and E Muldagalieva and E Simakina and T Ivanushkina and K Zakharov and L Melnikova and D Medvedev and O Zuev and D Kudlay and D Kruchko and I Berzin and R Valenta and V Skvortsova",

note = "Publisher Copyright: {\textcopyright} 2025 European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.",

year = "2025",

month = mar,

day = "3",

doi = "10.1111/all.16515",

language = "English",

journal = "Allergy: European Journal of Allergy and Clinical Immunology",

issn = "0105-4538",

publisher = "Wiley-Blackwell Publishing Ltd",

}

Khaitov, M, Nikonova, A, Smirnov, V, Shilovsky, I, Kofiadi, I, Ruzanova, E, Teplykh, V, Makarov, D, Vertichikh, A, Teplykh, S, Alpenidze, D, Muldagalieva, E, Simakina, E, Ivanushkina, T, Zakharov, K, Melnikova, L, Medvedev, D, Zuev, O, Kudlay, D, Kruchko, D, Berzin, I, Valenta, R & Skvortsova, V 2025, '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', Allergy: European Journal of Allergy and Clinical Immunology. https://doi.org/10.1111/all.16515

TY - JOUR

T1 - Phase 2-3 Trial

T2 - Prevention of the Progression to Moderate and Severe COVID-19 in SARS-CoV-2-Infected Non-Hospitalized Adults With Inhaled siRNA-Based MIR 19

AU - Khaitov, M

AU - Nikonova, A

AU - Smirnov, V

AU - Shilovsky, I

AU - Kofiadi, I

AU - Ruzanova, E

AU - Teplykh, V

AU - Makarov, D

AU - Vertichikh, A

AU - Teplykh, S

AU - Alpenidze, D

AU - Muldagalieva, E

AU - Simakina, E

AU - Ivanushkina, T

AU - Zakharov, K

AU - Melnikova, L

AU - Medvedev, D

AU - Zuev, O

AU - Kudlay, D

AU - Kruchko, D

AU - Berzin, I

AU - Valenta, R

AU - Skvortsova, V

PY - 2025/3/3

Y1 - 2025/3/3

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=86000251962&partnerID=8YFLogxK

U2 - 10.1111/all.16515

DO - 10.1111/all.16515

M3 - Journal article

C2 - 40028836

SN - 0105-4538

JO - Allergy: European Journal of Allergy and Clinical Immunology

JF - Allergy: European Journal of Allergy and Clinical Immunology

ER -

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

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