| Autor: |
Musa Khaitov, Alexandra Nikonova, Ilya Kofiadi, Igor Shilovskiy, Valeriy Smirnov, Olga G. Elisyutina, Artem Maerle, Artem Shatilov, Anastasia Timofeeva, Sergey Andreev, Ilya Sergeev, Dmitry Trofimov, Tatyana Latysheva, Nataliya Ilina, Alexander Martynov, Sevastyan Rabdano, Ellina Ruzanova, Nikita Savelev, Iuliia Pletiukhina, Ariana Safi, Vyacheslav Ratnikov, Viktor Gorelov, Viktor Kaschenko, Natalya Kucherenko, Irina Umarova, Svetlana Moskaleva, Sergei Fabrichnikov, Oleg Zuev, Nikolai Pavlov, Daria Kruchko, Igor Berzin, Dmitriy Goryachev, Vadim Merkulov, Victor Trukhin, Rudolf Valenta, Veronica Skvortsova |
| Rok vydání: |
2022 |
| Popis: |
BACKGROUND Severe acute respiratory syndrome corona virus (SARS-CoV-2) infection frequently causes severe and prolonged disease but only few specific treatments are available. We aimed to investigate safety and efficacy of a SARS-CoV-2-specific siRNA-peptide dendrimer formulation (MIR 19 ®) targeting a conserved sequence in known SARS-CoV-2 variants for treatment of COVID-19. METHODS We conducted an open-label, randomized controlled multicenter phase II trial (NCT05184127) evaluating safety and efficacy of inhaled MIR 19 ® (3.7mg and 11.1 mg/day: groups 1 and 2, respectively) in comparison with standard etiotropic drug treatment (group 3) in patients hospitalized with moderate COVID-19. The primary endpoint was the time to clinical improvement according to predefined criteria within 14 days of randomization. RESULTS Patients from group1 had a significantly reduced (median 6 days (95% confidence interval [CI]: 5-7, HR 1.75, P=0.0005) time to clinical improvement compared to patients from group 3 (8 days (95% CI: 7-10). Normalized oxygen saturation (SpO >94%) occurred quicker in the group 1 (median 5 days (95% CI: 4–5, HR 1.59, P=0.0033) than in the group 3 (6 days, 95% CI: 5–8). Treatment with MIR 19® was well tolerated and safe. CONCLUSIONS MIR 19 ®, a SARS-CoV-2-specific siRNA-peptide dendrimer formulation is safe and significantly reduces time to clinical improvement in hospitalized moderate COVID-19 patients compared to standard therapy in a randomized controlled trial. MIR 19 ® treatment targets a sequence which is identical in all SARS-CoV-2 variants known so far and hence should be applicable for all of them. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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