Efficacy and safety evaluation of Ingavirin® as COVID-19 antiviral therapy: clinical trial


如何引用文章

全文:

开放存取 开放存取
受限制的访问 ##reader.subscriptionAccessGranted##
受限制的访问 订阅或者付费存取

详细

There are two major clinical periods during COVID-19: the period of active viral reproduction and the period of immunologic mechanisms dysregulation, hyperinflammatory response. Thus, the early administration of antiviral therapy during is pathogenetically substantiated approach as it limitates virus replication and prevents life-threatening conditions development. One of the established antiviral drug with proven efficacy against the wide spectrum of respiratory viruses in adults and children is Ingavirin®. Ingavirin® activity against highly pathogenic coronavirus SARS-CoV has been proven during pre-clinical studies even before COVID-19 pandemic. Therefore, there were reliable reasons for studying the clinical efficacy of the drug in patients with new coronavirus infection. The aim of the phase III clinical study was to evaluate the efficacy and safety of Ingavirin®, 90 mg capsules, in outpatients with COVID-19. Material and methods. The study screened 234 patients of both sexes aged from 18 to 75 years with laboratory-confirmed mild COVID-19 233 of which were randomized in two groups: Ingavirin® group and placebo group. The maximum treatment duration was 7 days. The follow-up for 21±1 days was performed after the end of drug administration. Results and conclusion. The obtained results demonstrate the superiority of Ingavirin® therapy over placebo in the treatment of mild COVID-19 in terms of time to clinical recovery with a difference of 47,8 hours and faster regression of intoxication and catarrhal symptoms. Evaluation of adverse events and laboratory data confirm Ingavirin® favorable safety profile and tolerance.

全文:

受限制的访问

作者简介

A. Malyavin

A.I. Yevdokimov Moscow State University of Medicine and Dentistry of the Ministry of Healthcare of Russia

Email: maliavin@mail.ru
107150, Moscow, 39/2 Losinoostrovskaya Str

A. Gorelov

A.I. Yevdokimov Moscow State University of Medicine and Dentistry of the Ministry of Healthcare of Russia;Central Research Institute of Epidemiology of Rospotrebnadzor

111123, Moscow, 3А Novogireevskaya Str

E. Antonova

City Polyclinic No. 112

195427, Saint Petersburg, 25/1 Akademika Baykova Str

T. Pobedinskaya

Ivanovo Clinical Hospital named after Kuvaevs

153025, Ivanovo, 45 Akademika Maltseva Str

A. Globenko

JSC Valenta Pharm Pharmaceutical Company

Email: aleksandr.globenko0valentapharm.com
121471, Moscow, 26/10 Ryabinovaya Str

A. Kapashin

JSC Valenta Pharm Pharmaceutical Company

Email: aleksey.kapashin0valentapharm.com
121471, Moscow, 26/10 Ryabinovaya Str

M. Bagaeva

JSC Valenta Pharm Pharmaceutical Company

Email: madina.bagaeva0valentapharm.com
121471, Moscow, 26/10 Ryabinovaya Str

参考

  1. Рюленс М., Ваутерс Я. COVID-19: испытания и потрясения для глобального управления в сфере здравоохранения. Вестник международных организаций: образование, наука, новая экономика. 2021; 2: 70-98. @@Ruelens M., Wouters J. COVID-19 and the trials and tribulations of global health governance. Vestnik mezhdunarodnykh organizatsiy: obrazovaniye, nauka, novaya ekonomika = Bulletin of International Organizations: Education, Science, New Economy. 2021; 2: 70-98 (In Russ.)]. https://dx.doi.org/10.17323/1996-7845-2021-02-05.
  2. Временные методические рекомендации «Профилактика, диагностика и лечение новой коронавирусной инфекции (COVID-19)». Версия 15 (22.02.2022). Минздрав России. Доступ: https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/059/392/original/BMP_COVID-19_V15.pdf (дата обращения - 12.05.2022). @@Interim guidelines «Prevention, diagnosis and treatment of novel coronavirus infection (COVID-19)». Version 15 (02/22/2022). Ministry of Healthcare of Russia. URL: https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/059/392/original/BMP_COVID-19_V15.pdf(date of access - 12.05.2022).
  3. Cantini F., Goletti D., Petrone L. et al. Immune therapy, or antiviral therapy, or both for COVID-19: A systematic review. Drugs. 2020; 80(18): 1929-46. https://dx.doi.org/10.1007/s40265-020-01421-w.
  4. Wena W., Chena C., Tanga J. et al. Efficacy and safety of three new oral antiviral treatment (molnupiravir fluvoxamine and paxlovid] for COVID-19: A meta-analysis. Ann Med. 2022; 54(1): 516-23. https://dx.doi.org/10.1080/07853890.2022.2034936.
  5. Zhou S., Hill C.S., Sarkar S. et al. B-d-N4-hydroxycytidine inhibits SARSCoV-2 through lethal mutagenesis but is also mutagenic to mammalian cells. J Infect Dis. 2021; 224(3): 415-19. https://dx.doi.org/10.1093/infdis/jiab247.
  6. Pourkarim F., Pourtaghi-Anvarian S., Rezaee H. Molnupiravir: A new candidate for COVID-19 treatment. Pharmacol Res Perspect. 2022; 10(1): e00909. https://dx.doi.org/10.1002/prp2.909.
  7. Singh A.K., Singh A., Singh R., Misra A. Molnupiravir in COVID-19: A systematic review of literature. Diabetes Metab Syndr. 2021; 15(6): 102329. https://dx.doi.org/10.1016Zj.dsx.2021.102329.
  8. Shiraki K., Sato N., Sakai K. et al. Antiviral therapy for COVID-19: Derivation of optimal strategy based on past antiviral and favipiravir experiences. Pharmacol Ther. 2022; 235: 108121. https://dx.doi.org/10.1016/j.pharmthera.2022.108121.
  9. Pilkington V., Pepperrell T., Hill A. A review of the safety of favipiravir - a potential treatment in the COVID-19 pandemic? J Virus Erad. 2020; 6(2): 45-51. https://dx.doi.org/10.1016/S2055-6640(20)30016-9.
  10. Bosaeed M., Alharbi A., Mahmoud E. et al. Efficacy of favipiravir in adults with mild COVID-19: a randomized, double-blind, multicentre, placebo-controlled clinical trial. Clin Microbiol Infect. 2022; 28(4): 602-8. https://dx.doi.org/10.1016/j.cmi.2021.12.026.
  11. Holubar M., Subramanian A., Purington N. et al. Favipiravir for treatment of outpatients with asymptomatic or uncomplicated COVID-19: A double-blind randomized, placebo-controlled, phase 2 trial. Clin Infect Dis. 2022; ciac312. https://dx.doi.org/10.1093/cid/ciac312. Online ahead of print.
  12. AlQahtani M., Kumar N., Aljawder D. et al. Randomized controlled trial of favipiravir, hydroxychloroquine, and standard care in patients with mild/moderate COVID-19 disease. Sci Rep. 2022; 12(1): 4925. https://dx.doi.org/10.1038/s41598-022-08794-w.
  13. Лиманова О.А., Громова О.А., Федотова Л.Э. Комбинированная оральная контрацепция и лечение новой коронавирусной инфекции (COVID-19): вопросы взаимодействия лекарственных средств. Фармакокинетика и фармакодинамика. 2020; 3: 30-39. @@Limanova O.A., Gromova O.A., Fedotova L.E.Combined oral contraception and treatment of new coronavirus infection (COVID-19): drug interaction issues. Farmakokinetika i farmakodinamika = Pharmacokinetics and Pharmacodynamics. 2020; 3: 30-39 (In Russ.)]. https://dx.doi.org/10.37489/2587-7836-2020-3-30-39.
  14. Saravolatz L.D., Depcinski S., Sharma M. Molnupiravir and nirmatrelvir-ritonavir: Oral COVID antiviral drugs. Clin Infect Dis. 2022: ciac180. https://dx.doi.org/10.1093/cid/ciac180. Online ahead of print.
  15. Wang Y., Zhang D., Du G. et al. Remdesivir in adults with severe COVID-19: A randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2020; 395(10236): 1569-78. https://dx.doi.org/10.1016/S0140-6736(20)31022-9.
  16. Безопасность применения ремдесивира и тоцилизумаба при лечении COVID-19. Безопасность и риск фармакотерапии. 2020; 3: 160-162. @@Safety of remdesivir and tocilizumab in COVID-19 treatment. Bezopasnost' i risk farmakoterapii = Safety and Risk of Pharmacotherapy. 2020; 3: 160-162. (In Russ.)]. https://doi.org/10.30895/2312-7821-2020-8-3-160-162.
  17. Колобухина Л.В., Меркулова Л.Н., Щелканов М.Ю. с соавт. Эффективность Ингавирина в лечении гриппа у взрослых. Терапевтический архив. 2009; 3: 54-57. @@Kolobukhina L.V., Merkulova L.N., Shchelkanov M.Yu. et al. Efficacy of ingavirin in the treatment of influenza in adults. Terapevticheskiy arkhiv = Therapeutic Archive. 2009; 3: 54-57 (In Russ.)
  18. Колобухина Л.В. Щелканов М.Ю., Прошина Е.С. с соавт. Клинико-патогенетические особенности и оптимизация противовирусной терапии пандемического гриппа A(H1N1)pdm09. Вопросы вирусологии. 2012; S1: 189-198. @@Kolobukhina L.V., Shchelkanov M.Y., Proshina E.S. et al. Clinic and pathogenetic peculiarities and optimization of antiviral therapy of pandemic influenza А (H1N1) pdm09. Voprosy virusologii = Issues of virology. 2012; S1: 189-198 (In Russ.)
  19. Малявин А.Г, Крихели Н.И., Рогова И.В. с соавт. Терапия пациентов с COVID-19: результаты оценки эффективности и безопасности включения препарата Ингавирин® в схему рекомендованной стандартной терапии в реальной клинической практике. Терапия. 2021; 5: 22-32. @@Маlyavin A.G., Krikheli N.I., Rogova I.V. et al. COVID-19 therapy: the efficacy and safety of combination of Ingavirin® with standard recommended treatment in real clinical practice. Terapiya = Therapy. 2021; 5: 22-32 (In Russ.)]. https://dx.doi.org/10.18565/therapy.2021.5.22-32.
  20. Журавлева М.В., Мудунов А.М., Улумбекова ГЭ. Вектор на персонализированную медицину: от внедрения в практику до ожидаемых результатов. ОРГЗДРАВ: новости, мнения, обучение. Вестник ВШОУЗ. 2021; 4: 51-63. @@Zhuravleva M.V., Mudunov A.M., Ulumbekova G.E. Vector for personalized medicine: from practice implementation to expected results. ORGZDRAV: novosti, mneniya, obuchenie. Vestnik VSHOUZ = Healthcare management: News, Views, Education. Bulletin of Graduate School of Health Organization and Management. 2021; 4: 51-63 (In Russ.)]. https://dx.doi.org/10.33029/2411-8621-2021-7-4-51-63.
  21. Романовская А.А., Дурыманов А.М., Шаршов К.А. с соавт. Изучение чувствительности вирусов гриппа A(H1N1), вызвавших заболевания в апреле-мае 2009 года, к противовирусным препаратам в культуре клеток MDCK. Антибиотики и химиотерапия. 2009; 5-6: 41-47. @@Romanovskaya A.A., Durymanov A.M., Sharsov K.A. et al. Investigation of susceptibility of influenza viruses A (H1N1), the cause of infection in humans in April-May 2009, to Antivirals in MDCK Cell Culture. Antibiotiki i khimioterapiya = Antibiotics and Chemotherapy. 2009; 5-6: 41-47 (In Russ.)
  22. Кичатова В.С., Кюрегян К.К. Современный взгляд на резистентность к препаратам прямого противовирусного действия при лечении вирусного гепатита С. Инфекционные болезни: новости, мнения, обучение. 2019; 2: 64-71. @@Kichatova V.S., Kuregyan K.K. Modern view on resistance to direct antiviral drugs in the treatment of viral hepatitis C: analytical review. Infektsionnye bolezni: novosti, mneniya, obuchenie = Infectious Diseases: News, Opinions, Training. 2019; 2: 64-71 (In Russ.)]. https://dx.doi.org/10.24411/2305-3496-2019-12009.
  23. Negru P.A., Radu A.F., Vesa C.M. et al. Therapeutic dilemmas in addressing SARS-CoV-2 infection: Favipiravir versus remdesivir. Biomed Pharmacother. 2022; 147: 112700. https://dx.doi.org/10.1016/j.biopha.2022.112700.

补充文件

附件文件
动作
1. JATS XML
下载
##common.cookie##