| 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 |
| Authors: |
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. |
| Source: |
Allergy ; volume 80, issue 7, page 2031-2042 ; ISSN 0105-4538 1398-9995 |
| Publisher Information: |
Wiley |
| Publication Year: |
2025 |
| Collection: |
Wiley Online Library (Open Access Articles via Crossref) |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1111/all.16515 |
| Availability: |
https://doi.org/10.1111/all.16515; https://onlinelibrary.wiley.com/doi/pdf/10.1111/all.16515 |
| Rights: |
http://onlinelibrary.wiley.com/termsAndConditions#vor |
| Accession Number: |
edsbas.FA35EE0B |
| Database: |
BASE |