loading page

Treatment of COVID-19 patients with a SARS-CoV-2-specific siRNA-peptide dendrimer formulation
  • +33
  • 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
Musa Khaitov
FGBU Gosudarstvennyj naucnyj centr Institut immunologii Federal'nogo mediko-biologiceskogo agentstva Rossii

Corresponding Author:[email protected]

Author Profile
Alexandra Nikonova
FGBU Gosudarstvennyj naucnyj centr Institut immunologii Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Ilya Kofiadi
FGBU Gosudarstvennyj naucnyj centr Institut immunologii Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Igor Shilovskiy
FGBU Gosudarstvennyj naucnyj centr Institut immunologii Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Valeriy Smirnov
FGBU Gosudarstvennyj naucnyj centr Institut immunologii Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Olga G. Elisyutina
FGBU Gosudarstvennyj naucnyj centr Institut immunologii Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Artem Maerle
FGBU Gosudarstvennyj naucnyj centr Institut immunologii Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Artem Shatilov
FGBU Gosudarstvennyj naucnyj centr Institut immunologii Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Anastasia Timofeeva
FGBU Gosudarstvennyj naucnyj centr Institut immunologii Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Sergey Andreev
FGBU Gosudarstvennyj naucnyj centr Institut immunologii Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Ilya Sergeev
FGBU Gosudarstvennyj naucnyj centr Institut immunologii Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Dmitry Trofimov
FGBU Gosudarstvennyj naucnyj centr Institut immunologii Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Tatyana Latysheva
FGBU Gosudarstvennyj naucnyj centr Institut immunologii Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Nataliya Ilina
FGBU Gosudarstvennyj naucnyj centr Institut immunologii Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Alexander Martynov
FGBU Gosudarstvennyj naucnyj centr Institut immunologii Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Sevastyan Rabdano
FGUP Sankt-Peterburgskij naucno-issledovatel'skij institut vakcin i syvorotok i predpriatie po proizvodstvu bakterijnyh preparatov FMBA Rossii
Author Profile
Ellina Ruzanova
FGUP Sankt-Peterburgskij naucno-issledovatel'skij institut vakcin i syvorotok i predpriatie po proizvodstvu bakterijnyh preparatov FMBA Rossii
Author Profile
Nikita Savelev
FGUP Sankt-Peterburgskij naucno-issledovatel'skij institut vakcin i syvorotok i predpriatie po proizvodstvu bakterijnyh preparatov FMBA Rossii
Author Profile
Iuliia Pletiukhina
FGUP Sankt-Peterburgskij naucno-issledovatel'skij institut vakcin i syvorotok i predpriatie po proizvodstvu bakterijnyh preparatov FMBA Rossii
Author Profile
Ariana Safi
FGUP Sankt-Peterburgskij naucno-issledovatel'skij institut vakcin i syvorotok i predpriatie po proizvodstvu bakterijnyh preparatov FMBA Rossii
Author Profile
Vyacheslav Ratnikov
FGBUZ Kliniceskaa bol'nica No 122 imeni L G Sokolova Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Viktor Gorelov
FGBUZ Kliniceskaa bol'nica No 122 imeni L G Sokolova Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Viktor Kaschenko
FGBUZ Kliniceskaa bol'nica No 122 imeni L G Sokolova Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Natalya Kucherenko
FGBUZ Kliniceskaa bol'nica No 122 imeni L G Sokolova Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Irina Umarova
FGBUZ Kliniceskaa bol'nica No 122 imeni L G Sokolova Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Svetlana Moskaleva
FGBUZ Kliniceskaa bol'nica No 122 imeni L G Sokolova Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Sergei Fabrichnikov
FGBUZ Kliniceskaa bol'nica No 122 imeni L G Sokolova Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Oleg Zuev
Federal Clinical Center of High Medical Technologies of the Federal Medical and Biological Agency of Russia
Author Profile
Nikolai Pavlov
Federal Clinical Center of High Medical Technologies of the Federal Medical and Biological Agency of Russia
Author Profile
Daria Kruchko
Federal'noe mediko-biologiceskoe agentstvo Rossii
Author Profile
Igor Berzin
Federal'noe mediko-biologiceskoe agentstvo Rossii
Author Profile
Dmitriy Goryachev
Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation
Author Profile
Vadim Merkulov
Pervyj Moskovskij gosudarstvennyj medicinskij universitet imeni I M Secenova
Author Profile
Victor Trukhin
FGUP Sankt-Peterburgskij naucno-issledovatel'skij institut vakcin i syvorotok i predpriatie po proizvodstvu bakterijnyh preparatov FMBA Rossii
Author Profile
Rudolf Valenta
FGBU Gosudarstvennyj naucnyj centr Institut immunologii Federal'nogo mediko-biologiceskogo agentstva Rossii
Author Profile
Veronica Skvortsova
Federal'noe mediko-biologiceskoe agentstvo Rossii
Author Profile

Abstract

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 2>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.
28 Oct 2022Submitted to Allergy
30 Oct 2022Submission Checks Completed
30 Oct 2022Assigned to Editor
30 Oct 2022Review(s) Completed, Editorial Evaluation Pending
31 Oct 2022Reviewer(s) Assigned
22 Nov 2022Editorial Decision: Revise Minor
15 Dec 20221st Revision Received
15 Dec 2022Submission Checks Completed
15 Dec 2022Assigned to Editor
15 Dec 2022Review(s) Completed, Editorial Evaluation Pending
20 Dec 2022Reviewer(s) Assigned
30 Dec 2022Editorial Decision: Revise Minor
06 Jan 20232nd Revision Received
06 Jan 2023Review(s) Completed, Editorial Evaluation Pending
06 Jan 2023Submission Checks Completed
06 Jan 2023Assigned to Editor
13 Jan 2023Editorial Decision: Accept